Trial Outcomes & Findings for Alisporivir With RBV in Chronic Hepatitis C Genotype 2 and 3 Participants for Whom Interferon is Not an Option (NCT NCT02094443)
NCT ID: NCT02094443
Last Updated: 2016-10-13
Results Overview
The change in log transformed Hepatitis-C Virus (HCV) Ribonucleic acid (RNA) from baseline to Week 12.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
52 participants
Primary outcome timeframe
Baseline, Week 12
Results posted on
2016-10-13
Participant Flow
Participant milestones
| Measure |
Alisporivir 300 mg BID
Alisporivir (ALV) 300 mg twice per day (BID) with ribavirin (RBV) for up to 24 weeks.
|
Alisporivir 400 mg BID
ALV 400 mg BID with RBV for up to 24 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
26
|
26
|
|
Overall Study
Completed at Week 12
|
0
|
1
|
|
Overall Study
Completed at Week 24
|
11
|
8
|
|
Overall Study
COMPLETED
|
11
|
9
|
|
Overall Study
NOT COMPLETED
|
15
|
17
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Alisporivir With RBV in Chronic Hepatitis C Genotype 2 and 3 Participants for Whom Interferon is Not an Option
Baseline characteristics by cohort
| Measure |
Alisporivir 300 mg BID
n=26 Participants
ALV 300 mg BID with RBV for up to 24 weeks.
|
Alisporivir 400 mg BID
n=26 Participants
ALV 400 mg BID with RBV for up to 24 weeks.
|
Total
n=52 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53.4 years
STANDARD_DEVIATION 8.25 • n=99 Participants
|
54.5 years
STANDARD_DEVIATION 7.62 • n=107 Participants
|
53.9 years
STANDARD_DEVIATION 7.88 • n=206 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
32 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 12Population: Full Analysis Set
The change in log transformed Hepatitis-C Virus (HCV) Ribonucleic acid (RNA) from baseline to Week 12.
Outcome measures
| Measure |
Alisporivir 300 mg BID
n=26 Participants
ALV 300 mg BID with RBV for up to 24 weeks.
|
Alisporivir 400 mg BID
n=26 Participants
ALV 400 mg BID with RBV for up to 24 weeks.
|
|---|---|---|
|
Change From Baseline in Hepatitis C Virus Ribonucleic Acid Viral Load at Week 12
Baseline
|
6.323 log10 IU/mL
Standard Deviation 0.4785
|
6.343 log10 IU/mL
Standard Deviation 0.6396
|
|
Change From Baseline in Hepatitis C Virus Ribonucleic Acid Viral Load at Week 12
Change from baseline
|
-3.935 log10 IU/mL
Standard Deviation 2.3361
|
-3.855 log10 IU/mL
Standard Deviation 2.7506
|
PRIMARY outcome
Timeframe: Baseline, Week 12Population: Participants in the safety set with available data at the given time point
ALT levels were assessed as part of clinical chemistry assessments throughout the study as a measure of biochemical liver recovery. A negative change from baseline indicates less liver damage.
Outcome measures
| Measure |
Alisporivir 300 mg BID
n=21 Participants
ALV 300 mg BID with RBV for up to 24 weeks.
|
Alisporivir 400 mg BID
n=19 Participants
ALV 400 mg BID with RBV for up to 24 weeks.
|
|---|---|---|
|
Change From Baseline in Alanine Aminotransferase (ALT) at Week 12
Baseline
|
77.3 U/L
Standard Deviation 48.57
|
67.9 U/L
Standard Deviation 42.94
|
|
Change From Baseline in Alanine Aminotransferase (ALT) at Week 12
Change from baseline
|
-67.4 U/L
Standard Deviation 45.99
|
-58.2 U/L
Standard Deviation 44.50
|
SECONDARY outcome
Timeframe: Up to 24 weeks posttreatmentPopulation: Full Analysis Set
SVR is defined as HCV RNA less than the lower limit of quantification (LLOQ), i.e., \<15 IU/mL, at 4 weeks (SVR4), 12 weeks (SVR12), and 24 weeks (SVR24) after treatment, respectively.
Outcome measures
| Measure |
Alisporivir 300 mg BID
n=26 Participants
ALV 300 mg BID with RBV for up to 24 weeks.
|
Alisporivir 400 mg BID
n=26 Participants
ALV 400 mg BID with RBV for up to 24 weeks.
|
|---|---|---|
|
Percentage of Participants Achieving Sustained Virologic Response (SVR) 4, 12, and 24 Weeks After Treatment
SVR4
|
30.8 percentage of participants
|
38.5 percentage of participants
|
|
Percentage of Participants Achieving Sustained Virologic Response (SVR) 4, 12, and 24 Weeks After Treatment
SVR12
|
19.2 percentage of participants
|
26.9 percentage of participants
|
|
Percentage of Participants Achieving Sustained Virologic Response (SVR) 4, 12, and 24 Weeks After Treatment
SVR24
|
19.2 percentage of participants
|
26.9 percentage of participants
|
SECONDARY outcome
Timeframe: 2 weeksPopulation: Full Analysis Set
Extended rapid virologic response (eRVR) was defined as serum HCV RNA \< LLOQ after 2 weeks of treatment
Outcome measures
| Measure |
Alisporivir 300 mg BID
n=26 Participants
ALV 300 mg BID with RBV for up to 24 weeks.
|
Alisporivir 400 mg BID
n=26 Participants
ALV 400 mg BID with RBV for up to 24 weeks.
|
|---|---|---|
|
Percentage of Participants With Extended Rapid Virologic Response
|
0.0 percentage of participants
|
3.8 percentage of participants
|
SECONDARY outcome
Timeframe: 4 weeksPopulation: Full Analysis Set
eRVR was defined as serum HCV RNA \< LLOQ after 4 weeks of treatment
Outcome measures
| Measure |
Alisporivir 300 mg BID
n=26 Participants
ALV 300 mg BID with RBV for up to 24 weeks.
|
Alisporivir 400 mg BID
n=26 Participants
ALV 400 mg BID with RBV for up to 24 weeks.
|
|---|---|---|
|
Percentage of Participants With Rapid Virologic Response (RVR)
|
3.8 percentage of participants
|
15.4 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 24 weeksPopulation: Full Analysis Set
ETR was defined as serum HCV RNA \< LLOQ at treatment end (completed or prematurely discontinued).
Outcome measures
| Measure |
Alisporivir 300 mg BID
n=26 Participants
ALV 300 mg BID with RBV for up to 24 weeks.
|
Alisporivir 400 mg BID
n=26 Participants
ALV 400 mg BID with RBV for up to 24 weeks.
|
|---|---|---|
|
Percentage of Participants With End of Treatment Response (ETR)
|
46.2 percentage of participants
|
50.0 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 24 weeksPopulation: Full Analysis Set
ALT is an enzyme found mostly in the cells of the liver and kidney. When the liver is damaged, ALT is released into the blood. This makes ALT a common test for liver damage, because higher ALT levels may indicate more liver damage. ALT upper limit of normal is commonly considered to be 40 international units per liter (IU/L), so abnormal ALT is above 40 IU/L.
Outcome measures
| Measure |
Alisporivir 300 mg BID
n=26 Participants
ALV 300 mg BID with RBV for up to 24 weeks.
|
Alisporivir 400 mg BID
n=26 Participants
ALV 400 mg BID with RBV for up to 24 weeks.
|
|---|---|---|
|
Percentage of Participants With Abnormal Alanine Aminotransferase (ALT) at Baseline Who Had Normalized ALT at Treatment End and Study End
End of Treatment
|
73.1 percentage of participants
|
61.5 percentage of participants
|
|
Percentage of Participants With Abnormal Alanine Aminotransferase (ALT) at Baseline Who Had Normalized ALT at Treatment End and Study End
End of Study
|
38.5 percentage of participants
|
42.3 percentage of participants
|
Adverse Events
Alisporivir 300 mg BID
Serious events: 3 serious events
Other events: 22 other events
Deaths: 0 deaths
Alisporivir 400 mg BID
Serious events: 3 serious events
Other events: 24 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Alisporivir 300 mg BID
n=26 participants at risk
ALV 300 mg BID with RBV for up to 24 weeks.
|
Alisporivir 400 mg BID
n=26 participants at risk
ALV 400 mg BID with RBV for up to 24 weeks.
|
|---|---|---|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/26 • Adverse events were collected from first subject first visit until last subject last visit. All reported serious adverse events occurred during treatment.
The mean exposure to alisporivir and ribavirin or to their combination regimen was 17 weeks for the 300 mg arm and 15 weeks for the 400 mg arm.
|
3.8%
1/26 • Adverse events were collected from first subject first visit until last subject last visit. All reported serious adverse events occurred during treatment.
The mean exposure to alisporivir and ribavirin or to their combination regimen was 17 weeks for the 300 mg arm and 15 weeks for the 400 mg arm.
|
|
General disorders
General physical health deterioration
|
3.8%
1/26 • Adverse events were collected from first subject first visit until last subject last visit. All reported serious adverse events occurred during treatment.
The mean exposure to alisporivir and ribavirin or to their combination regimen was 17 weeks for the 300 mg arm and 15 weeks for the 400 mg arm.
|
0.00%
0/26 • Adverse events were collected from first subject first visit until last subject last visit. All reported serious adverse events occurred during treatment.
The mean exposure to alisporivir and ribavirin or to their combination regimen was 17 weeks for the 300 mg arm and 15 weeks for the 400 mg arm.
|
|
Infections and infestations
Epiglottitis
|
3.8%
1/26 • Adverse events were collected from first subject first visit until last subject last visit. All reported serious adverse events occurred during treatment.
The mean exposure to alisporivir and ribavirin or to their combination regimen was 17 weeks for the 300 mg arm and 15 weeks for the 400 mg arm.
|
0.00%
0/26 • Adverse events were collected from first subject first visit until last subject last visit. All reported serious adverse events occurred during treatment.
The mean exposure to alisporivir and ribavirin or to their combination regimen was 17 weeks for the 300 mg arm and 15 weeks for the 400 mg arm.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/26 • Adverse events were collected from first subject first visit until last subject last visit. All reported serious adverse events occurred during treatment.
The mean exposure to alisporivir and ribavirin or to their combination regimen was 17 weeks for the 300 mg arm and 15 weeks for the 400 mg arm.
|
3.8%
1/26 • Adverse events were collected from first subject first visit until last subject last visit. All reported serious adverse events occurred during treatment.
The mean exposure to alisporivir and ribavirin or to their combination regimen was 17 weeks for the 300 mg arm and 15 weeks for the 400 mg arm.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
3.8%
1/26 • Adverse events were collected from first subject first visit until last subject last visit. All reported serious adverse events occurred during treatment.
The mean exposure to alisporivir and ribavirin or to their combination regimen was 17 weeks for the 300 mg arm and 15 weeks for the 400 mg arm.
|
0.00%
0/26 • Adverse events were collected from first subject first visit until last subject last visit. All reported serious adverse events occurred during treatment.
The mean exposure to alisporivir and ribavirin or to their combination regimen was 17 weeks for the 300 mg arm and 15 weeks for the 400 mg arm.
|
|
Vascular disorders
Hypertension
|
0.00%
0/26 • Adverse events were collected from first subject first visit until last subject last visit. All reported serious adverse events occurred during treatment.
The mean exposure to alisporivir and ribavirin or to their combination regimen was 17 weeks for the 300 mg arm and 15 weeks for the 400 mg arm.
|
3.8%
1/26 • Adverse events were collected from first subject first visit until last subject last visit. All reported serious adverse events occurred during treatment.
The mean exposure to alisporivir and ribavirin or to their combination regimen was 17 weeks for the 300 mg arm and 15 weeks for the 400 mg arm.
|
Other adverse events
| Measure |
Alisporivir 300 mg BID
n=26 participants at risk
ALV 300 mg BID with RBV for up to 24 weeks.
|
Alisporivir 400 mg BID
n=26 participants at risk
ALV 400 mg BID with RBV for up to 24 weeks.
|
|---|---|---|
|
Vascular disorders
Hypertension
|
15.4%
4/26 • Adverse events were collected from first subject first visit until last subject last visit. All reported serious adverse events occurred during treatment.
The mean exposure to alisporivir and ribavirin or to their combination regimen was 17 weeks for the 300 mg arm and 15 weeks for the 400 mg arm.
|
19.2%
5/26 • Adverse events were collected from first subject first visit until last subject last visit. All reported serious adverse events occurred during treatment.
The mean exposure to alisporivir and ribavirin or to their combination regimen was 17 weeks for the 300 mg arm and 15 weeks for the 400 mg arm.
|
|
General disorders
Fatigue
|
23.1%
6/26 • Adverse events were collected from first subject first visit until last subject last visit. All reported serious adverse events occurred during treatment.
The mean exposure to alisporivir and ribavirin or to their combination regimen was 17 weeks for the 300 mg arm and 15 weeks for the 400 mg arm.
|
23.1%
6/26 • Adverse events were collected from first subject first visit until last subject last visit. All reported serious adverse events occurred during treatment.
The mean exposure to alisporivir and ribavirin or to their combination regimen was 17 weeks for the 300 mg arm and 15 weeks for the 400 mg arm.
|
|
General disorders
Asthenia
|
19.2%
5/26 • Adverse events were collected from first subject first visit until last subject last visit. All reported serious adverse events occurred during treatment.
The mean exposure to alisporivir and ribavirin or to their combination regimen was 17 weeks for the 300 mg arm and 15 weeks for the 400 mg arm.
|
46.2%
12/26 • Adverse events were collected from first subject first visit until last subject last visit. All reported serious adverse events occurred during treatment.
The mean exposure to alisporivir and ribavirin or to their combination regimen was 17 weeks for the 300 mg arm and 15 weeks for the 400 mg arm.
|
|
Psychiatric disorders
Anxiety
|
3.8%
1/26 • Adverse events were collected from first subject first visit until last subject last visit. All reported serious adverse events occurred during treatment.
The mean exposure to alisporivir and ribavirin or to their combination regimen was 17 weeks for the 300 mg arm and 15 weeks for the 400 mg arm.
|
15.4%
4/26 • Adverse events were collected from first subject first visit until last subject last visit. All reported serious adverse events occurred during treatment.
The mean exposure to alisporivir and ribavirin or to their combination regimen was 17 weeks for the 300 mg arm and 15 weeks for the 400 mg arm.
|
|
Psychiatric disorders
Depression
|
3.8%
1/26 • Adverse events were collected from first subject first visit until last subject last visit. All reported serious adverse events occurred during treatment.
The mean exposure to alisporivir and ribavirin or to their combination regimen was 17 weeks for the 300 mg arm and 15 weeks for the 400 mg arm.
|
11.5%
3/26 • Adverse events were collected from first subject first visit until last subject last visit. All reported serious adverse events occurred during treatment.
The mean exposure to alisporivir and ribavirin or to their combination regimen was 17 weeks for the 300 mg arm and 15 weeks for the 400 mg arm.
|
|
Psychiatric disorders
Irritability
|
11.5%
3/26 • Adverse events were collected from first subject first visit until last subject last visit. All reported serious adverse events occurred during treatment.
The mean exposure to alisporivir and ribavirin or to their combination regimen was 17 weeks for the 300 mg arm and 15 weeks for the 400 mg arm.
|
7.7%
2/26 • Adverse events were collected from first subject first visit until last subject last visit. All reported serious adverse events occurred during treatment.
The mean exposure to alisporivir and ribavirin or to their combination regimen was 17 weeks for the 300 mg arm and 15 weeks for the 400 mg arm.
|
|
Psychiatric disorders
Insomnia
|
15.4%
4/26 • Adverse events were collected from first subject first visit until last subject last visit. All reported serious adverse events occurred during treatment.
The mean exposure to alisporivir and ribavirin or to their combination regimen was 17 weeks for the 300 mg arm and 15 weeks for the 400 mg arm.
|
15.4%
4/26 • Adverse events were collected from first subject first visit until last subject last visit. All reported serious adverse events occurred during treatment.
The mean exposure to alisporivir and ribavirin or to their combination regimen was 17 weeks for the 300 mg arm and 15 weeks for the 400 mg arm.
|
|
Blood and lymphatic system disorders
Anaemia
|
19.2%
5/26 • Adverse events were collected from first subject first visit until last subject last visit. All reported serious adverse events occurred during treatment.
The mean exposure to alisporivir and ribavirin or to their combination regimen was 17 weeks for the 300 mg arm and 15 weeks for the 400 mg arm.
|
26.9%
7/26 • Adverse events were collected from first subject first visit until last subject last visit. All reported serious adverse events occurred during treatment.
The mean exposure to alisporivir and ribavirin or to their combination regimen was 17 weeks for the 300 mg arm and 15 weeks for the 400 mg arm.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
19.2%
5/26 • Adverse events were collected from first subject first visit until last subject last visit. All reported serious adverse events occurred during treatment.
The mean exposure to alisporivir and ribavirin or to their combination regimen was 17 weeks for the 300 mg arm and 15 weeks for the 400 mg arm.
|
23.1%
6/26 • Adverse events were collected from first subject first visit until last subject last visit. All reported serious adverse events occurred during treatment.
The mean exposure to alisporivir and ribavirin or to their combination regimen was 17 weeks for the 300 mg arm and 15 weeks for the 400 mg arm.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
7.7%
2/26 • Adverse events were collected from first subject first visit until last subject last visit. All reported serious adverse events occurred during treatment.
The mean exposure to alisporivir and ribavirin or to their combination regimen was 17 weeks for the 300 mg arm and 15 weeks for the 400 mg arm.
|
0.00%
0/26 • Adverse events were collected from first subject first visit until last subject last visit. All reported serious adverse events occurred during treatment.
The mean exposure to alisporivir and ribavirin or to their combination regimen was 17 weeks for the 300 mg arm and 15 weeks for the 400 mg arm.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/26 • Adverse events were collected from first subject first visit until last subject last visit. All reported serious adverse events occurred during treatment.
The mean exposure to alisporivir and ribavirin or to their combination regimen was 17 weeks for the 300 mg arm and 15 weeks for the 400 mg arm.
|
7.7%
2/26 • Adverse events were collected from first subject first visit until last subject last visit. All reported serious adverse events occurred during treatment.
The mean exposure to alisporivir and ribavirin or to their combination regimen was 17 weeks for the 300 mg arm and 15 weeks for the 400 mg arm.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/26 • Adverse events were collected from first subject first visit until last subject last visit. All reported serious adverse events occurred during treatment.
The mean exposure to alisporivir and ribavirin or to their combination regimen was 17 weeks for the 300 mg arm and 15 weeks for the 400 mg arm.
|
11.5%
3/26 • Adverse events were collected from first subject first visit until last subject last visit. All reported serious adverse events occurred during treatment.
The mean exposure to alisporivir and ribavirin or to their combination regimen was 17 weeks for the 300 mg arm and 15 weeks for the 400 mg arm.
|
|
Nervous system disorders
Headache
|
15.4%
4/26 • Adverse events were collected from first subject first visit until last subject last visit. All reported serious adverse events occurred during treatment.
The mean exposure to alisporivir and ribavirin or to their combination regimen was 17 weeks for the 300 mg arm and 15 weeks for the 400 mg arm.
|
26.9%
7/26 • Adverse events were collected from first subject first visit until last subject last visit. All reported serious adverse events occurred during treatment.
The mean exposure to alisporivir and ribavirin or to their combination regimen was 17 weeks for the 300 mg arm and 15 weeks for the 400 mg arm.
|
|
Nervous system disorders
Syncope
|
7.7%
2/26 • Adverse events were collected from first subject first visit until last subject last visit. All reported serious adverse events occurred during treatment.
The mean exposure to alisporivir and ribavirin or to their combination regimen was 17 weeks for the 300 mg arm and 15 weeks for the 400 mg arm.
|
7.7%
2/26 • Adverse events were collected from first subject first visit until last subject last visit. All reported serious adverse events occurred during treatment.
The mean exposure to alisporivir and ribavirin or to their combination regimen was 17 weeks for the 300 mg arm and 15 weeks for the 400 mg arm.
|
|
Eye disorders
Ocular icterus
|
7.7%
2/26 • Adverse events were collected from first subject first visit until last subject last visit. All reported serious adverse events occurred during treatment.
The mean exposure to alisporivir and ribavirin or to their combination regimen was 17 weeks for the 300 mg arm and 15 weeks for the 400 mg arm.
|
3.8%
1/26 • Adverse events were collected from first subject first visit until last subject last visit. All reported serious adverse events occurred during treatment.
The mean exposure to alisporivir and ribavirin or to their combination regimen was 17 weeks for the 300 mg arm and 15 weeks for the 400 mg arm.
|
|
Eye disorders
Dry eye
|
7.7%
2/26 • Adverse events were collected from first subject first visit until last subject last visit. All reported serious adverse events occurred during treatment.
The mean exposure to alisporivir and ribavirin or to their combination regimen was 17 weeks for the 300 mg arm and 15 weeks for the 400 mg arm.
|
7.7%
2/26 • Adverse events were collected from first subject first visit until last subject last visit. All reported serious adverse events occurred during treatment.
The mean exposure to alisporivir and ribavirin or to their combination regimen was 17 weeks for the 300 mg arm and 15 weeks for the 400 mg arm.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/26 • Adverse events were collected from first subject first visit until last subject last visit. All reported serious adverse events occurred during treatment.
The mean exposure to alisporivir and ribavirin or to their combination regimen was 17 weeks for the 300 mg arm and 15 weeks for the 400 mg arm.
|
7.7%
2/26 • Adverse events were collected from first subject first visit until last subject last visit. All reported serious adverse events occurred during treatment.
The mean exposure to alisporivir and ribavirin or to their combination regimen was 17 weeks for the 300 mg arm and 15 weeks for the 400 mg arm.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/26 • Adverse events were collected from first subject first visit until last subject last visit. All reported serious adverse events occurred during treatment.
The mean exposure to alisporivir and ribavirin or to their combination regimen was 17 weeks for the 300 mg arm and 15 weeks for the 400 mg arm.
|
7.7%
2/26 • Adverse events were collected from first subject first visit until last subject last visit. All reported serious adverse events occurred during treatment.
The mean exposure to alisporivir and ribavirin or to their combination regimen was 17 weeks for the 300 mg arm and 15 weeks for the 400 mg arm.
|
|
Gastrointestinal disorders
Constipation
|
11.5%
3/26 • Adverse events were collected from first subject first visit until last subject last visit. All reported serious adverse events occurred during treatment.
The mean exposure to alisporivir and ribavirin or to their combination regimen was 17 weeks for the 300 mg arm and 15 weeks for the 400 mg arm.
|
3.8%
1/26 • Adverse events were collected from first subject first visit until last subject last visit. All reported serious adverse events occurred during treatment.
The mean exposure to alisporivir and ribavirin or to their combination regimen was 17 weeks for the 300 mg arm and 15 weeks for the 400 mg arm.
|
|
Gastrointestinal disorders
Diarrhoea
|
7.7%
2/26 • Adverse events were collected from first subject first visit until last subject last visit. All reported serious adverse events occurred during treatment.
The mean exposure to alisporivir and ribavirin or to their combination regimen was 17 weeks for the 300 mg arm and 15 weeks for the 400 mg arm.
|
15.4%
4/26 • Adverse events were collected from first subject first visit until last subject last visit. All reported serious adverse events occurred during treatment.
The mean exposure to alisporivir and ribavirin or to their combination regimen was 17 weeks for the 300 mg arm and 15 weeks for the 400 mg arm.
|
|
Gastrointestinal disorders
Dry mouth
|
7.7%
2/26 • Adverse events were collected from first subject first visit until last subject last visit. All reported serious adverse events occurred during treatment.
The mean exposure to alisporivir and ribavirin or to their combination regimen was 17 weeks for the 300 mg arm and 15 weeks for the 400 mg arm.
|
3.8%
1/26 • Adverse events were collected from first subject first visit until last subject last visit. All reported serious adverse events occurred during treatment.
The mean exposure to alisporivir and ribavirin or to their combination regimen was 17 weeks for the 300 mg arm and 15 weeks for the 400 mg arm.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/26 • Adverse events were collected from first subject first visit until last subject last visit. All reported serious adverse events occurred during treatment.
The mean exposure to alisporivir and ribavirin or to their combination regimen was 17 weeks for the 300 mg arm and 15 weeks for the 400 mg arm.
|
7.7%
2/26 • Adverse events were collected from first subject first visit until last subject last visit. All reported serious adverse events occurred during treatment.
The mean exposure to alisporivir and ribavirin or to their combination regimen was 17 weeks for the 300 mg arm and 15 weeks for the 400 mg arm.
|
|
Gastrointestinal disorders
Nausea
|
15.4%
4/26 • Adverse events were collected from first subject first visit until last subject last visit. All reported serious adverse events occurred during treatment.
The mean exposure to alisporivir and ribavirin or to their combination regimen was 17 weeks for the 300 mg arm and 15 weeks for the 400 mg arm.
|
15.4%
4/26 • Adverse events were collected from first subject first visit until last subject last visit. All reported serious adverse events occurred during treatment.
The mean exposure to alisporivir and ribavirin or to their combination regimen was 17 weeks for the 300 mg arm and 15 weeks for the 400 mg arm.
|
|
Gastrointestinal disorders
Vomiting
|
7.7%
2/26 • Adverse events were collected from first subject first visit until last subject last visit. All reported serious adverse events occurred during treatment.
The mean exposure to alisporivir and ribavirin or to their combination regimen was 17 weeks for the 300 mg arm and 15 weeks for the 400 mg arm.
|
11.5%
3/26 • Adverse events were collected from first subject first visit until last subject last visit. All reported serious adverse events occurred during treatment.
The mean exposure to alisporivir and ribavirin or to their combination regimen was 17 weeks for the 300 mg arm and 15 weeks for the 400 mg arm.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/26 • Adverse events were collected from first subject first visit until last subject last visit. All reported serious adverse events occurred during treatment.
The mean exposure to alisporivir and ribavirin or to their combination regimen was 17 weeks for the 300 mg arm and 15 weeks for the 400 mg arm.
|
7.7%
2/26 • Adverse events were collected from first subject first visit until last subject last visit. All reported serious adverse events occurred during treatment.
The mean exposure to alisporivir and ribavirin or to their combination regimen was 17 weeks for the 300 mg arm and 15 weeks for the 400 mg arm.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
3.8%
1/26 • Adverse events were collected from first subject first visit until last subject last visit. All reported serious adverse events occurred during treatment.
The mean exposure to alisporivir and ribavirin or to their combination regimen was 17 weeks for the 300 mg arm and 15 weeks for the 400 mg arm.
|
7.7%
2/26 • Adverse events were collected from first subject first visit until last subject last visit. All reported serious adverse events occurred during treatment.
The mean exposure to alisporivir and ribavirin or to their combination regimen was 17 weeks for the 300 mg arm and 15 weeks for the 400 mg arm.
|
|
Skin and subcutaneous tissue disorders
Pruritis generalised
|
3.8%
1/26 • Adverse events were collected from first subject first visit until last subject last visit. All reported serious adverse events occurred during treatment.
The mean exposure to alisporivir and ribavirin or to their combination regimen was 17 weeks for the 300 mg arm and 15 weeks for the 400 mg arm.
|
7.7%
2/26 • Adverse events were collected from first subject first visit until last subject last visit. All reported serious adverse events occurred during treatment.
The mean exposure to alisporivir and ribavirin or to their combination regimen was 17 weeks for the 300 mg arm and 15 weeks for the 400 mg arm.
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
19.2%
5/26 • Adverse events were collected from first subject first visit until last subject last visit. All reported serious adverse events occurred during treatment.
The mean exposure to alisporivir and ribavirin or to their combination regimen was 17 weeks for the 300 mg arm and 15 weeks for the 400 mg arm.
|
15.4%
4/26 • Adverse events were collected from first subject first visit until last subject last visit. All reported serious adverse events occurred during treatment.
The mean exposure to alisporivir and ribavirin or to their combination regimen was 17 weeks for the 300 mg arm and 15 weeks for the 400 mg arm.
|
|
Skin and subcutaneous tissue disorders
Rash
|
11.5%
3/26 • Adverse events were collected from first subject first visit until last subject last visit. All reported serious adverse events occurred during treatment.
The mean exposure to alisporivir and ribavirin or to their combination regimen was 17 weeks for the 300 mg arm and 15 weeks for the 400 mg arm.
|
11.5%
3/26 • Adverse events were collected from first subject first visit until last subject last visit. All reported serious adverse events occurred during treatment.
The mean exposure to alisporivir and ribavirin or to their combination regimen was 17 weeks for the 300 mg arm and 15 weeks for the 400 mg arm.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
7.7%
2/26 • Adverse events were collected from first subject first visit until last subject last visit. All reported serious adverse events occurred during treatment.
The mean exposure to alisporivir and ribavirin or to their combination regimen was 17 weeks for the 300 mg arm and 15 weeks for the 400 mg arm.
|
11.5%
3/26 • Adverse events were collected from first subject first visit until last subject last visit. All reported serious adverse events occurred during treatment.
The mean exposure to alisporivir and ribavirin or to their combination regimen was 17 weeks for the 300 mg arm and 15 weeks for the 400 mg arm.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
7.7%
2/26 • Adverse events were collected from first subject first visit until last subject last visit. All reported serious adverse events occurred during treatment.
The mean exposure to alisporivir and ribavirin or to their combination regimen was 17 weeks for the 300 mg arm and 15 weeks for the 400 mg arm.
|
3.8%
1/26 • Adverse events were collected from first subject first visit until last subject last visit. All reported serious adverse events occurred during treatment.
The mean exposure to alisporivir and ribavirin or to their combination regimen was 17 weeks for the 300 mg arm and 15 weeks for the 400 mg arm.
|
|
Infections and infestations
Bronchitis
|
7.7%
2/26 • Adverse events were collected from first subject first visit until last subject last visit. All reported serious adverse events occurred during treatment.
The mean exposure to alisporivir and ribavirin or to their combination regimen was 17 weeks for the 300 mg arm and 15 weeks for the 400 mg arm.
|
3.8%
1/26 • Adverse events were collected from first subject first visit until last subject last visit. All reported serious adverse events occurred during treatment.
The mean exposure to alisporivir and ribavirin or to their combination regimen was 17 weeks for the 300 mg arm and 15 weeks for the 400 mg arm.
|
|
Infections and infestations
Nasopharyngitis
|
7.7%
2/26 • Adverse events were collected from first subject first visit until last subject last visit. All reported serious adverse events occurred during treatment.
The mean exposure to alisporivir and ribavirin or to their combination regimen was 17 weeks for the 300 mg arm and 15 weeks for the 400 mg arm.
|
0.00%
0/26 • Adverse events were collected from first subject first visit until last subject last visit. All reported serious adverse events occurred during treatment.
The mean exposure to alisporivir and ribavirin or to their combination regimen was 17 weeks for the 300 mg arm and 15 weeks for the 400 mg arm.
|
|
Infections and infestations
Urinary tract infection
|
11.5%
3/26 • Adverse events were collected from first subject first visit until last subject last visit. All reported serious adverse events occurred during treatment.
The mean exposure to alisporivir and ribavirin or to their combination regimen was 17 weeks for the 300 mg arm and 15 weeks for the 400 mg arm.
|
3.8%
1/26 • Adverse events were collected from first subject first visit until last subject last visit. All reported serious adverse events occurred during treatment.
The mean exposure to alisporivir and ribavirin or to their combination regimen was 17 weeks for the 300 mg arm and 15 weeks for the 400 mg arm.
|
Additional Information
Vice President Clinical Research & Development
Debiopharm International S.A.
Phone: 4121 321 01 11
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER