Trial Outcomes & Findings for Study of Nitazoxanide, Peginterferon Alfa-2a and Ribavirin for the Treatment of Hepatitis C (NCT NCT00495391)
NCT ID: NCT00495391
Last Updated: 2014-05-08
Results Overview
Hepatitis C Virus Ribonucleic Acid (HCV RNA) below lower limit of detection 24 weeks after the end of treatment. All others were considered non-responders.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
64 participants
Primary outcome timeframe
24 weeks after end of treatment
Results posted on
2014-05-08
Participant Flow
This study recruited patients from 10 study sites in the United States, including a Veterans Administrations hospital.
Participant milestones
| Measure |
NTZ+PR
Oral 500 mg nitazoxanide twice daily for 4 weeks followed by oral 500 mg nitazoxanide twice daily plus weekly injections of peginterferon alfa-2a plus oral ribavirin (1000 mg if \<75 kg body weight or 1200 mg if ≥75 kg body weight) in daily divided doses for 48 weeks.
Ribavirin : 1000 mg (if \<75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks.
Nitazoxanide : One oral 500 mg nitazoxanide tablet twice daily for 52 weeks.
Peginterferon alfa-2a : Weekly injections of 180µg peginterferon alfa-2a for 48 weeks.
|
Placebo+PR
Oral placebo twice daily for 4 weeks followed by oral placebo twice daily plus weekly injections of peginterferon alfa-2a plus oral ribavirin (1000 mg if \<75 kg body weight or 1200 mg if ≥75 kg body weight) in daily divided doses for 48 weeks.
Ribavirin : 1000 mg (if \<75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks.
Peginterferon alfa-2a : Weekly injections of 180µg peginterferon alfa-2a for 48 weeks.
Placebo : One oral placebo tablet twice daily for 52 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
42
|
22
|
|
Overall Study
From Baseline to Week 8
|
31
|
20
|
|
Overall Study
From Baseline to Week 16
|
24
|
11
|
|
Overall Study
From Baseline to End of Treatment
|
6
|
1
|
|
Overall Study
From Baseline to End of Follow up
|
6
|
1
|
|
Overall Study
COMPLETED
|
6
|
1
|
|
Overall Study
NOT COMPLETED
|
36
|
21
|
Reasons for withdrawal
| Measure |
NTZ+PR
Oral 500 mg nitazoxanide twice daily for 4 weeks followed by oral 500 mg nitazoxanide twice daily plus weekly injections of peginterferon alfa-2a plus oral ribavirin (1000 mg if \<75 kg body weight or 1200 mg if ≥75 kg body weight) in daily divided doses for 48 weeks.
Ribavirin : 1000 mg (if \<75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks.
Nitazoxanide : One oral 500 mg nitazoxanide tablet twice daily for 52 weeks.
Peginterferon alfa-2a : Weekly injections of 180µg peginterferon alfa-2a for 48 weeks.
|
Placebo+PR
Oral placebo twice daily for 4 weeks followed by oral placebo twice daily plus weekly injections of peginterferon alfa-2a plus oral ribavirin (1000 mg if \<75 kg body weight or 1200 mg if ≥75 kg body weight) in daily divided doses for 48 weeks.
Ribavirin : 1000 mg (if \<75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks.
Peginterferon alfa-2a : Weekly injections of 180µg peginterferon alfa-2a for 48 weeks.
Placebo : One oral placebo tablet twice daily for 52 weeks.
|
|---|---|---|
|
Overall Study
Lack of Efficacy
|
34
|
18
|
|
Overall Study
Withdrawal by Subject
|
2
|
3
|
Baseline Characteristics
Study of Nitazoxanide, Peginterferon Alfa-2a and Ribavirin for the Treatment of Hepatitis C
Baseline characteristics by cohort
| Measure |
NTZ+PR
n=42 Participants
Oral 500 mg nitazoxanide twice daily for 4 weeks followed by oral 500 mg nitazoxanide twice daily plus weekly injections of peginterferon alfa-2a plus oral ribavirin (1000 mg if \<75 kg body weight or 1200 mg if ≥75 kg body weight) in daily divided doses for 48 weeks.
Ribavirin : 1000 mg (if \<75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks.
Nitazoxanide : One oral 500 mg nitazoxanide tablet twice daily for 52 weeks.
Peginterferon alfa-2a : Weekly injections of 180µg peginterferon alfa-2a for 48 weeks.
|
Placebo+PR
n=22 Participants
Oral placebo twice daily for 4 weeks followed by oral placebo twice daily plus weekly injections of peginterferon alfa-2a plus oral ribavirin (1000 mg if \<75 kg body weight or 1200 mg if ≥75 kg body weight) in daily divided doses for 48 weeks.
Ribavirin : 1000 mg (if \<75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks.
Peginterferon alfa-2a : Weekly injections of 180µg peginterferon alfa-2a for 48 weeks.
Placebo : One oral placebo tablet twice daily for 52 weeks.
|
Total
n=64 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
39 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
60 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Age, Continuous
|
54 years
STANDARD_DEVIATION 8 • n=99 Participants
|
53 years
STANDARD_DEVIATION 6 • n=107 Participants
|
53.5 years
STANDARD_DEVIATION 6.9 • n=206 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
43 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
42 participants
n=99 Participants
|
22 participants
n=107 Participants
|
64 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 24 weeks after end of treatmentHepatitis C Virus Ribonucleic Acid (HCV RNA) below lower limit of detection 24 weeks after the end of treatment. All others were considered non-responders.
Outcome measures
| Measure |
NTZ+PR
n=42 Participants
Oral 500 mg nitazoxanide twice daily for 4 weeks followed by oral 500 mg nitazoxanide twice daily plus weekly injections of peginterferon alfa-2a plus oral ribavirin (1000 mg if \<75 kg body weight or 1200 mg if ≥75 kg body weight) in daily divided doses for 48 weeks.
Ribavirin : 1000 mg (if \<75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks.
Nitazoxanide : One oral 500 mg nitazoxanide tablet twice daily for 52 weeks.
Peginterferon alfa-2a : Weekly injections of 180µg peginterferon alfa-2a for 48 weeks.
|
Placebo+PR
n=22 Participants
Oral placebo twice daily for 4 weeks followed by oral placebo twice daily plus weekly injections of peginterferon alfa-2a plus oral ribavirin (1000 mg if \<75 kg body weight or 1200 mg if ≥75 kg body weight) in daily divided doses for 48 weeks.
Ribavirin : 1000 mg (if \<75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks.
Peginterferon alfa-2a : Weekly injections of 180µg peginterferon alfa-2a for 48 weeks.
Placebo : One oral placebo tablet twice daily for 52 weeks.
|
|---|---|---|
|
Sustained Virologic Response (HCV RNA Below Lower Limit of Detection)
Responders
|
3 participants
|
0 participants
|
|
Sustained Virologic Response (HCV RNA Below Lower Limit of Detection)
Non-responders
|
39 participants
|
22 participants
|
SECONDARY outcome
Timeframe: At end of treatmentHepatitis C Virus Ribonucleic Acid (HCV RNA) below lower limit of detection at the end of treatment. All others were considered non-responders.
Outcome measures
| Measure |
NTZ+PR
n=42 Participants
Oral 500 mg nitazoxanide twice daily for 4 weeks followed by oral 500 mg nitazoxanide twice daily plus weekly injections of peginterferon alfa-2a plus oral ribavirin (1000 mg if \<75 kg body weight or 1200 mg if ≥75 kg body weight) in daily divided doses for 48 weeks.
Ribavirin : 1000 mg (if \<75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks.
Nitazoxanide : One oral 500 mg nitazoxanide tablet twice daily for 52 weeks.
Peginterferon alfa-2a : Weekly injections of 180µg peginterferon alfa-2a for 48 weeks.
|
Placebo+PR
n=22 Participants
Oral placebo twice daily for 4 weeks followed by oral placebo twice daily plus weekly injections of peginterferon alfa-2a plus oral ribavirin (1000 mg if \<75 kg body weight or 1200 mg if ≥75 kg body weight) in daily divided doses for 48 weeks.
Ribavirin : 1000 mg (if \<75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks.
Peginterferon alfa-2a : Weekly injections of 180µg peginterferon alfa-2a for 48 weeks.
Placebo : One oral placebo tablet twice daily for 52 weeks.
|
|---|---|---|
|
End of Treatment Response (HCV RNA Below Lower Limit of Detection)
Responders
|
6 participants
|
1 participants
|
|
End of Treatment Response (HCV RNA Below Lower Limit of Detection)
Non-responders
|
36 participants
|
21 participants
|
SECONDARY outcome
Timeframe: After 12 weeks combination treatmentHepatitis C Virus Ribonucleic Acid (HCV RNA) below lower limit of detection after 12 weeks of combination therapy.
Outcome measures
| Measure |
NTZ+PR
n=42 Participants
Oral 500 mg nitazoxanide twice daily for 4 weeks followed by oral 500 mg nitazoxanide twice daily plus weekly injections of peginterferon alfa-2a plus oral ribavirin (1000 mg if \<75 kg body weight or 1200 mg if ≥75 kg body weight) in daily divided doses for 48 weeks.
Ribavirin : 1000 mg (if \<75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks.
Nitazoxanide : One oral 500 mg nitazoxanide tablet twice daily for 52 weeks.
Peginterferon alfa-2a : Weekly injections of 180µg peginterferon alfa-2a for 48 weeks.
|
Placebo+PR
n=22 Participants
Oral placebo twice daily for 4 weeks followed by oral placebo twice daily plus weekly injections of peginterferon alfa-2a plus oral ribavirin (1000 mg if \<75 kg body weight or 1200 mg if ≥75 kg body weight) in daily divided doses for 48 weeks.
Ribavirin : 1000 mg (if \<75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks.
Peginterferon alfa-2a : Weekly injections of 180µg peginterferon alfa-2a for 48 weeks.
Placebo : One oral placebo tablet twice daily for 52 weeks.
|
|---|---|---|
|
Early Virologic Response (HCV RNA Below Lower Limit of Detection)
Responders
|
3 participants
|
0 participants
|
|
Early Virologic Response (HCV RNA Below Lower Limit of Detection)
Non-responders
|
39 participants
|
22 participants
|
SECONDARY outcome
Timeframe: After 4 weeks combination treatmentHepatitis C Virus Ribonucleic Acid (HCV RNA) below lower limit of detection after 4 weeks of combination therapy.
Outcome measures
| Measure |
NTZ+PR
n=42 Participants
Oral 500 mg nitazoxanide twice daily for 4 weeks followed by oral 500 mg nitazoxanide twice daily plus weekly injections of peginterferon alfa-2a plus oral ribavirin (1000 mg if \<75 kg body weight or 1200 mg if ≥75 kg body weight) in daily divided doses for 48 weeks.
Ribavirin : 1000 mg (if \<75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks.
Nitazoxanide : One oral 500 mg nitazoxanide tablet twice daily for 52 weeks.
Peginterferon alfa-2a : Weekly injections of 180µg peginterferon alfa-2a for 48 weeks.
|
Placebo+PR
n=22 Participants
Oral placebo twice daily for 4 weeks followed by oral placebo twice daily plus weekly injections of peginterferon alfa-2a plus oral ribavirin (1000 mg if \<75 kg body weight or 1200 mg if ≥75 kg body weight) in daily divided doses for 48 weeks.
Ribavirin : 1000 mg (if \<75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks.
Peginterferon alfa-2a : Weekly injections of 180µg peginterferon alfa-2a for 48 weeks.
Placebo : One oral placebo tablet twice daily for 52 weeks.
|
|---|---|---|
|
Rapid Virologic Response (HCV RNA Below Lower Limit of Detection)
Non-responders
|
40 participants
|
22 participants
|
|
Rapid Virologic Response (HCV RNA Below Lower Limit of Detection)
Responders
|
2 participants
|
0 participants
|
SECONDARY outcome
Timeframe: From baseline to week 8This analysis was conducted using a comparison of changes in Alanine aminotransferase (ALT) from baseline through week 8, week 16, end of treatment and end of follow up.
Outcome measures
| Measure |
NTZ+PR
n=31 Participants
Oral 500 mg nitazoxanide twice daily for 4 weeks followed by oral 500 mg nitazoxanide twice daily plus weekly injections of peginterferon alfa-2a plus oral ribavirin (1000 mg if \<75 kg body weight or 1200 mg if ≥75 kg body weight) in daily divided doses for 48 weeks.
Ribavirin : 1000 mg (if \<75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks.
Nitazoxanide : One oral 500 mg nitazoxanide tablet twice daily for 52 weeks.
Peginterferon alfa-2a : Weekly injections of 180µg peginterferon alfa-2a for 48 weeks.
|
Placebo+PR
n=20 Participants
Oral placebo twice daily for 4 weeks followed by oral placebo twice daily plus weekly injections of peginterferon alfa-2a plus oral ribavirin (1000 mg if \<75 kg body weight or 1200 mg if ≥75 kg body weight) in daily divided doses for 48 weeks.
Ribavirin : 1000 mg (if \<75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks.
Peginterferon alfa-2a : Weekly injections of 180µg peginterferon alfa-2a for 48 weeks.
Placebo : One oral placebo tablet twice daily for 52 weeks.
|
|---|---|---|
|
Changes in ALT
Remains Elevated
|
14 participants
|
8 participants
|
|
Changes in ALT
Elevated to Normal
|
7 participants
|
2 participants
|
|
Changes in ALT
Remains Normal
|
9 participants
|
9 participants
|
|
Changes in ALT
Normal to Elevated
|
1 participants
|
1 participants
|
SECONDARY outcome
Timeframe: From baseline to week 16This analysis was conducted using a comparison of changes in Alanine aminotransferase (ALT) from baseline through week 8, week 16, end of treatment and end of follow up.
Outcome measures
| Measure |
NTZ+PR
n=24 Participants
Oral 500 mg nitazoxanide twice daily for 4 weeks followed by oral 500 mg nitazoxanide twice daily plus weekly injections of peginterferon alfa-2a plus oral ribavirin (1000 mg if \<75 kg body weight or 1200 mg if ≥75 kg body weight) in daily divided doses for 48 weeks.
Ribavirin : 1000 mg (if \<75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks.
Nitazoxanide : One oral 500 mg nitazoxanide tablet twice daily for 52 weeks.
Peginterferon alfa-2a : Weekly injections of 180µg peginterferon alfa-2a for 48 weeks.
|
Placebo+PR
n=11 Participants
Oral placebo twice daily for 4 weeks followed by oral placebo twice daily plus weekly injections of peginterferon alfa-2a plus oral ribavirin (1000 mg if \<75 kg body weight or 1200 mg if ≥75 kg body weight) in daily divided doses for 48 weeks.
Ribavirin : 1000 mg (if \<75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks.
Peginterferon alfa-2a : Weekly injections of 180µg peginterferon alfa-2a for 48 weeks.
Placebo : One oral placebo tablet twice daily for 52 weeks.
|
|---|---|---|
|
Changes in ALT
Remains Elevated
|
6 participants
|
2 participants
|
|
Changes in ALT
Elevated to Normal
|
6 participants
|
2 participants
|
|
Changes in ALT
Remains Normal
|
12 participants
|
6 participants
|
|
Changes in ALT
Normal to Elevated
|
0 participants
|
1 participants
|
SECONDARY outcome
Timeframe: From baseline to end of treatmentThis analysis was conducted using a comparison of changes in Alanine aminotransferase (ALT) from baseline through week 8, week 16, end of treatment and end of follow up.
Outcome measures
| Measure |
NTZ+PR
n=6 Participants
Oral 500 mg nitazoxanide twice daily for 4 weeks followed by oral 500 mg nitazoxanide twice daily plus weekly injections of peginterferon alfa-2a plus oral ribavirin (1000 mg if \<75 kg body weight or 1200 mg if ≥75 kg body weight) in daily divided doses for 48 weeks.
Ribavirin : 1000 mg (if \<75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks.
Nitazoxanide : One oral 500 mg nitazoxanide tablet twice daily for 52 weeks.
Peginterferon alfa-2a : Weekly injections of 180µg peginterferon alfa-2a for 48 weeks.
|
Placebo+PR
n=1 Participants
Oral placebo twice daily for 4 weeks followed by oral placebo twice daily plus weekly injections of peginterferon alfa-2a plus oral ribavirin (1000 mg if \<75 kg body weight or 1200 mg if ≥75 kg body weight) in daily divided doses for 48 weeks.
Ribavirin : 1000 mg (if \<75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks.
Peginterferon alfa-2a : Weekly injections of 180µg peginterferon alfa-2a for 48 weeks.
Placebo : One oral placebo tablet twice daily for 52 weeks.
|
|---|---|---|
|
Changes in ALT
Remains Elevated
|
0 participants
|
0 participants
|
|
Changes in ALT
Elevated to Normal
|
1 participants
|
0 participants
|
|
Changes in ALT
Remains Normal
|
5 participants
|
1 participants
|
|
Changes in ALT
Normal to Elevated
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: From baseline to end of follow upThis analysis was conducted using a comparison of changes in Alanine aminotransferase (ALT) from baseline through week 8, week 16, end of treatment and end of follow up.
Outcome measures
| Measure |
NTZ+PR
n=6 Participants
Oral 500 mg nitazoxanide twice daily for 4 weeks followed by oral 500 mg nitazoxanide twice daily plus weekly injections of peginterferon alfa-2a plus oral ribavirin (1000 mg if \<75 kg body weight or 1200 mg if ≥75 kg body weight) in daily divided doses for 48 weeks.
Ribavirin : 1000 mg (if \<75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks.
Nitazoxanide : One oral 500 mg nitazoxanide tablet twice daily for 52 weeks.
Peginterferon alfa-2a : Weekly injections of 180µg peginterferon alfa-2a for 48 weeks.
|
Placebo+PR
n=1 Participants
Oral placebo twice daily for 4 weeks followed by oral placebo twice daily plus weekly injections of peginterferon alfa-2a plus oral ribavirin (1000 mg if \<75 kg body weight or 1200 mg if ≥75 kg body weight) in daily divided doses for 48 weeks.
Ribavirin : 1000 mg (if \<75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks.
Peginterferon alfa-2a : Weekly injections of 180µg peginterferon alfa-2a for 48 weeks.
Placebo : One oral placebo tablet twice daily for 52 weeks.
|
|---|---|---|
|
Changes in ALT
Normal to Elevated
|
1 participants
|
0 participants
|
|
Changes in ALT
Remains Elevated
|
0 participants
|
0 participants
|
|
Changes in ALT
Elevated to Normal
|
1 participants
|
0 participants
|
|
Changes in ALT
Remains Normal
|
4 participants
|
1 participants
|
Adverse Events
NTZ+PR
Serious events: 1 serious events
Other events: 42 other events
Deaths: 0 deaths
Placebo+PR
Serious events: 1 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
NTZ+PR
n=42 participants at risk
Oral 500 mg nitazoxanide twice daily for 4 weeks followed by oral 500 mg nitazoxanide twice daily plus weekly injections of peginterferon alfa-2a plus oral ribavirin (1000 mg if \<75 kg body weight or 1200 mg if ≥75 kg body weight) in daily divided doses for 48 weeks.
Ribavirin : 1000 mg (if \<75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks.
Nitazoxanide : One oral 500 mg nitazoxanide tablet twice daily for 52 weeks.
Peginterferon alfa-2a : Weekly injections of 180µg peginterferon alfa-2a for 48 weeks.
|
Placebo+PR
n=22 participants at risk
Oral placebo twice daily for 4 weeks followed by oral placebo twice daily plus weekly injections of peginterferon alfa-2a plus oral ribavirin (1000 mg if \<75 kg body weight or 1200 mg if ≥75 kg body weight) in daily divided doses for 48 weeks.
Ribavirin : 1000 mg (if \<75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks.
Peginterferon alfa-2a : Weekly injections of 180µg peginterferon alfa-2a for 48 weeks.
Placebo : One oral placebo tablet twice daily for 52 weeks.
|
|---|---|---|
|
Renal and urinary disorders
Pyelonephritis
|
2.4%
1/42 • Number of events 1 • 2 years, 1 month
|
0.00%
0/22 • 2 years, 1 month
|
|
Renal and urinary disorders
Kidney Calculus
|
2.4%
1/42 • Number of events 1 • 2 years, 1 month
|
0.00%
0/22 • 2 years, 1 month
|
|
Respiratory, thoracic and mediastinal disorders
Edema Larynx
|
0.00%
0/42 • 2 years, 1 month
|
4.5%
1/22 • Number of events 1 • 2 years, 1 month
|
Other adverse events
| Measure |
NTZ+PR
n=42 participants at risk
Oral 500 mg nitazoxanide twice daily for 4 weeks followed by oral 500 mg nitazoxanide twice daily plus weekly injections of peginterferon alfa-2a plus oral ribavirin (1000 mg if \<75 kg body weight or 1200 mg if ≥75 kg body weight) in daily divided doses for 48 weeks.
Ribavirin : 1000 mg (if \<75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks.
Nitazoxanide : One oral 500 mg nitazoxanide tablet twice daily for 52 weeks.
Peginterferon alfa-2a : Weekly injections of 180µg peginterferon alfa-2a for 48 weeks.
|
Placebo+PR
n=22 participants at risk
Oral placebo twice daily for 4 weeks followed by oral placebo twice daily plus weekly injections of peginterferon alfa-2a plus oral ribavirin (1000 mg if \<75 kg body weight or 1200 mg if ≥75 kg body weight) in daily divided doses for 48 weeks.
Ribavirin : 1000 mg (if \<75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks.
Peginterferon alfa-2a : Weekly injections of 180µg peginterferon alfa-2a for 48 weeks.
Placebo : One oral placebo tablet twice daily for 52 weeks.
|
|---|---|---|
|
General disorders
Asthenia
|
54.8%
23/42 • Number of events 23 • 2 years, 1 month
|
45.5%
10/22 • Number of events 10 • 2 years, 1 month
|
|
Gastrointestinal disorders
Pain Abdo
|
21.4%
9/42 • Number of events 9 • 2 years, 1 month
|
9.1%
2/22 • Number of events 2 • 2 years, 1 month
|
|
General disorders
Headache
|
21.4%
9/42 • Number of events 9 • 2 years, 1 month
|
27.3%
6/22 • Number of events 6 • 2 years, 1 month
|
|
General disorders
Pain Back
|
14.3%
6/42 • Number of events 6 • 2 years, 1 month
|
0.00%
0/22 • 2 years, 1 month
|
|
General disorders
Flu Synd
|
11.9%
5/42 • Number of events 5 • 2 years, 1 month
|
9.1%
2/22 • Number of events 2 • 2 years, 1 month
|
|
Gastrointestinal disorders
Diarrhea
|
40.5%
17/42 • Number of events 17 • 2 years, 1 month
|
13.6%
3/22 • Number of events 3 • 2 years, 1 month
|
|
Gastrointestinal disorders
Nausea
|
23.8%
10/42 • Number of events 10 • 2 years, 1 month
|
18.2%
4/22 • Number of events 4 • 2 years, 1 month
|
|
Gastrointestinal disorders
Anorexia
|
14.3%
6/42 • Number of events 6 • 2 years, 1 month
|
4.5%
1/22 • Number of events 1 • 2 years, 1 month
|
|
Gastrointestinal disorders
Constip
|
11.9%
5/42 • Number of events 5 • 2 years, 1 month
|
9.1%
2/22 • Number of events 2 • 2 years, 1 month
|
|
Gastrointestinal disorders
Liver Func Abnorm
|
9.5%
4/42 • Number of events 4 • 2 years, 1 month
|
4.5%
1/22 • Number of events 1 • 2 years, 1 month
|
|
Gastrointestinal disorders
Dry Mouth
|
2.4%
1/42 • Number of events 1 • 2 years, 1 month
|
13.6%
3/22 • Number of events 3 • 2 years, 1 month
|
|
Blood and lymphatic system disorders
Leukopenia
|
47.6%
20/42 • Number of events 20 • 2 years, 1 month
|
36.4%
8/22 • Number of events 8 • 2 years, 1 month
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
28.6%
12/42 • Number of events 12 • 2 years, 1 month
|
13.6%
3/22 • Number of events 3 • 2 years, 1 month
|
|
Blood and lymphatic system disorders
Anemia
|
26.2%
11/42 • Number of events 11 • 2 years, 1 month
|
22.7%
5/22 • Number of events 5 • 2 years, 1 month
|
|
Nervous system disorders
Agitation
|
28.6%
12/42 • Number of events 12 • 2 years, 1 month
|
27.3%
6/22 • Number of events 6 • 2 years, 1 month
|
|
Nervous system disorders
Depression
|
19.0%
8/42 • Number of events 8 • 2 years, 1 month
|
22.7%
5/22 • Number of events 5 • 2 years, 1 month
|
|
Nervous system disorders
Insomnia
|
19.0%
8/42 • Number of events 8 • 2 years, 1 month
|
18.2%
4/22 • Number of events 4 • 2 years, 1 month
|
|
Nervous system disorders
Anxiety
|
2.4%
1/42 • Number of events 1 • 2 years, 1 month
|
18.2%
4/22 • Number of events 4 • 2 years, 1 month
|
|
Nervous system disorders
Dizziness
|
16.7%
7/42 • Number of events 7 • 2 years, 1 month
|
13.6%
3/22 • Number of events 3 • 2 years, 1 month
|
|
Skin and subcutaneous tissue disorders
Rash
|
21.4%
9/42 • Number of events 9 • 2 years, 1 month
|
22.7%
5/22 • Number of events 5 • 2 years, 1 month
|
|
Skin and subcutaneous tissue disorders
Skin Dry
|
16.7%
7/42 • Number of events 7 • 2 years, 1 month
|
9.1%
2/22 • Number of events 2 • 2 years, 1 month
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
11.9%
5/42 • Number of events 5 • 2 years, 1 month
|
9.1%
2/22 • Number of events 2 • 2 years, 1 month
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
9.5%
4/42 • Number of events 4 • 2 years, 1 month
|
13.6%
3/22 • Number of events 3 • 2 years, 1 month
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngitis
|
14.3%
6/42 • Number of events 6 • 2 years, 1 month
|
4.5%
1/22 • Number of events 1 • 2 years, 1 month
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis
|
9.5%
4/42 • Number of events 4 • 2 years, 1 month
|
13.6%
3/22 • Number of events 3 • 2 years, 1 month
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
7.1%
3/42 • Number of events 3 • 2 years, 1 month
|
13.6%
3/22 • Number of events 3 • 2 years, 1 month
|
|
Respiratory, thoracic and mediastinal disorders
Cough Inc
|
7.1%
3/42 • Number of events 3 • 2 years, 1 month
|
13.6%
3/22 • Number of events 3 • 2 years, 1 month
|
|
Metabolism and nutrition disorders
Albuminuria
|
14.3%
6/42 • Number of events 6 • 2 years, 1 month
|
13.6%
3/22 • Number of events 3 • 2 years, 1 month
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
16.7%
7/42 • Number of events 7 • 2 years, 1 month
|
9.1%
2/22 • Number of events 2 • 2 years, 1 month
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
9.5%
4/42 • Number of events 4 • 2 years, 1 month
|
0.00%
0/22 • 2 years, 1 month
|
|
Musculoskeletal and connective tissue disorders
Cramps Leg
|
9.5%
4/42 • Number of events 4 • 2 years, 1 month
|
0.00%
0/22 • 2 years, 1 month
|
|
Renal and urinary disorders
Polyuria
|
11.9%
5/42 • Number of events 5 • 2 years, 1 month
|
9.1%
2/22 • Number of events 2 • 2 years, 1 month
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Presentation and/or publication is encouraged provided the Sponsor is notified in advance and given the opportunity to review the manuscript or abstract 30 days prior to its submission for presentation at a scientific meeting or for publication in a scientific journal. The investigators will have complete autonomy regarding the content and wording including the decision of whether or not to publish.
- Publication restrictions are in place
Restriction type: OTHER