Trial Outcomes & Findings for Interferon-alpha Lozenges for Prevention of Relapse in Hepatitis C (NCT NCT00695019)
NCT ID: NCT00695019
Last Updated: 2024-02-21
Results Overview
Percentage of participants with a positive seum HCV RNA level at any post-baseline evaluation Serum HCV RNA was tested using a commercially available real-time polymerase-chain-reaction (PCR) assay kit (Roche Cobas TaqMan HCV assay kit) with a limit of detection of 15 IU/ml.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
169 participants
Primary outcome timeframe
48 weeks
Results posted on
2024-02-21
Participant Flow
Subjects undergoing treatment for HCV infection at one of the 9 participating hospitals were approached, and those willing to sign informed consent were screened for eligibility.
A total of 196 subjects were screened. All 169 subjects meeting eligibility criteria were randomized to one of the 3 treatment groups and all 169 were included in the intent-to-treat analysis.
Participant milestones
| Measure |
500 IU qd
500 IU Interferon-alpha lozenge taken once per day plus 2 placebo lozenges
|
500 IU Tid
500 IU interferon-alpha lozenge taken 3 times per day
|
Placebo
placebo lozenges taken 3 times per day
|
|---|---|---|---|
|
Overall Study
STARTED
|
59
|
53
|
57
|
|
Overall Study
COMPLETED
|
46
|
39
|
47
|
|
Overall Study
NOT COMPLETED
|
13
|
14
|
10
|
Reasons for withdrawal
| Measure |
500 IU qd
500 IU Interferon-alpha lozenge taken once per day plus 2 placebo lozenges
|
500 IU Tid
500 IU interferon-alpha lozenge taken 3 times per day
|
Placebo
placebo lozenges taken 3 times per day
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
8
|
6
|
4
|
|
Overall Study
Protocol Violation
|
1
|
3
|
1
|
|
Overall Study
Lack of Efficacy
|
0
|
0
|
1
|
|
Overall Study
Various
|
4
|
5
|
4
|
Baseline Characteristics
Interferon-alpha Lozenges for Prevention of Relapse in Hepatitis C
Baseline characteristics by cohort
| Measure |
500 IU qd
n=59 Participants
500 IU Interferon-alpha lozenge taken once per day plus 2 placebo lozenges
|
500 IU Tid
n=53 Participants
500 IU interferon-alpha lozenge taken 3 times per day
|
Placebo
n=57 Participants
placebo lozenges taken 3 times per day
|
Total
n=169 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
|
0 Participants
n=7 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
47 Participants
n=99 Participants
|
44 Participants
n=107 Participants
|
47 Participants
n=206 Participants
|
138 Participants
n=7 Participants
|
|
Age, Categorical
>=65 years
|
12 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
31 Participants
n=7 Participants
|
|
Age, Continuous
|
54.9 years
STANDARD_DEVIATION 11.9 • n=99 Participants
|
55.7 years
STANDARD_DEVIATION 10.8 • n=107 Participants
|
56.8 years
STANDARD_DEVIATION 9.5 • n=206 Participants
|
55.8 years
STANDARD_DEVIATION 10.8 • n=7 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=99 Participants
|
26 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
78 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=99 Participants
|
27 Participants
n=107 Participants
|
32 Participants
n=206 Participants
|
91 Participants
n=7 Participants
|
|
Region of Enrollment
Taiwan
|
59 participants
n=99 Participants
|
53 participants
n=107 Participants
|
57 participants
n=206 Participants
|
169 participants
n=7 Participants
|
PRIMARY outcome
Timeframe: 48 weeksPopulation: Intent-to-treat
Percentage of participants with a positive seum HCV RNA level at any post-baseline evaluation Serum HCV RNA was tested using a commercially available real-time polymerase-chain-reaction (PCR) assay kit (Roche Cobas TaqMan HCV assay kit) with a limit of detection of 15 IU/ml.
Outcome measures
| Measure |
500 IU qd
n=59 Participants
500 IU Interferon-alpha lozenge taken once per day plus 2 placebo lozenges per day
|
500 IU Tid
n=53 Participants
500 IU interferon-alpha lozenge taken 3 times per day
|
Placebo
n=57 Participants
placebo lozenges taken 3 times per day
|
|---|---|---|---|
|
Relapse Rate
|
30.5 percentage of participants
|
37.7 percentage of participants
|
35.1 percentage of participants
|
SECONDARY outcome
Timeframe: 48 weeksPopulation: Intent-to-treat
Percentage of participants who remained HCV RNA negative throughout the study
Outcome measures
| Measure |
500 IU qd
n=59 Participants
500 IU Interferon-alpha lozenge taken once per day plus 2 placebo lozenges per day
|
500 IU Tid
n=53 Participants
500 IU interferon-alpha lozenge taken 3 times per day
|
Placebo
n=57 Participants
placebo lozenges taken 3 times per day
|
|---|---|---|---|
|
Sustained Virologic Response Rate
|
71.2 percentage of participants
|
62.3 percentage of participants
|
66.7 percentage of participants
|
SECONDARY outcome
Timeframe: 48 weeksPopulation: Intent-to-treat
Percentage of participants with a normal serum ALT level at the end of the study
Outcome measures
| Measure |
500 IU qd
n=59 Participants
500 IU Interferon-alpha lozenge taken once per day plus 2 placebo lozenges per day
|
500 IU Tid
n=53 Participants
500 IU interferon-alpha lozenge taken 3 times per day
|
Placebo
n=57 Participants
placebo lozenges taken 3 times per day
|
|---|---|---|---|
|
Normalization of ALT
|
71.2 percentage of participants
|
60.4 percentage of participants
|
64.9 percentage of participants
|
SECONDARY outcome
Timeframe: 48 weeksPopulation: Intent-to-treat population
Change in serum HCV RNA concentration (log10 IU) from baseline to week 48
Outcome measures
| Measure |
500 IU qd
n=59 Participants
500 IU Interferon-alpha lozenge taken once per day plus 2 placebo lozenges per day
|
500 IU Tid
n=53 Participants
500 IU interferon-alpha lozenge taken 3 times per day
|
Placebo
n=57 Participants
placebo lozenges taken 3 times per day
|
|---|---|---|---|
|
Change in Serum HCV RNA Concentration
|
1.6 log10 IU
Standard Deviation 2.4
|
1.9 log10 IU
Standard Deviation 2.5
|
1.7 log10 IU
Standard Deviation 2.5
|
SECONDARY outcome
Timeframe: 48 weeksPopulation: Intent-to-treat
Change in Serum ALT concentration from baseline to week 48
Outcome measures
| Measure |
500 IU qd
n=59 Participants
500 IU Interferon-alpha lozenge taken once per day plus 2 placebo lozenges per day
|
500 IU Tid
n=53 Participants
500 IU interferon-alpha lozenge taken 3 times per day
|
Placebo
n=57 Participants
placebo lozenges taken 3 times per day
|
|---|---|---|---|
|
Change in Serum ALT
|
7.8 U/L
Standard Deviation 75.5
|
0.6 U/L
Standard Deviation 36.6
|
8.6 U/L
Standard Deviation 52.6
|
SECONDARY outcome
Timeframe: 48 weeksPopulation: Intent-to-treat
Change in the Social Functioning domain of the SF-36 quality-of-life questionnaire from baseline to week 48 Social Functioning (SF) scores range from 0-100, with lower scores indicating that health/emotional problems have had a greater negative impact on social activities, compared to higher scores. SF scores are calculated using a proprietary algorithm based on responses to questions #6 and #10 on the SF-36, which are 5-point likert scales about the extent to which, and the amount of time with which physical or emotional problems have interfered with social activities.
Outcome measures
| Measure |
500 IU qd
n=59 Participants
500 IU Interferon-alpha lozenge taken once per day plus 2 placebo lozenges per day
|
500 IU Tid
n=53 Participants
500 IU interferon-alpha lozenge taken 3 times per day
|
Placebo
n=57 Participants
placebo lozenges taken 3 times per day
|
|---|---|---|---|
|
Change in Social Functioning
|
21.6 change in score
Standard Deviation 17.7
|
16.3 change in score
Standard Deviation 20.9
|
8.8 change in score
Standard Deviation 20.5
|
SECONDARY outcome
Timeframe: 48 weeksChange in fibrotest score from baseline to week 48
Outcome measures
| Measure |
500 IU qd
n=59 Participants
500 IU Interferon-alpha lozenge taken once per day plus 2 placebo lozenges per day
|
500 IU Tid
n=53 Participants
500 IU interferon-alpha lozenge taken 3 times per day
|
Placebo
n=57 Participants
placebo lozenges taken 3 times per day
|
|---|---|---|---|
|
Change in Fibrotest Score
|
-0.37 units on a scale
Standard Deviation 0.48
|
-0.19 units on a scale
Standard Deviation 0.46
|
-0.31 units on a scale
Standard Deviation 0.37
|
POST_HOC outcome
Timeframe: 48 weeksPopulation: Participants with a baseline platelet count below 150 who were evaluable for response at week 48 were included in the analysis
Percentage of participants with a low platelet count at baseline who had a normal platelet count at the end of the study
Outcome measures
| Measure |
500 IU qd
n=21 Participants
500 IU Interferon-alpha lozenge taken once per day plus 2 placebo lozenges per day
|
500 IU Tid
n=24 Participants
500 IU interferon-alpha lozenge taken 3 times per day
|
Placebo
n=31 Participants
placebo lozenges taken 3 times per day
|
|---|---|---|---|
|
Normalization of Platelets
|
81.0 percentage of participants
|
50.0 percentage of participants
|
41.9 percentage of participants
|
Adverse Events
500 IU qd
Serious events: 2 serious events
Other events: 52 other events
Deaths: 0 deaths
500 IU Tid
Serious events: 6 serious events
Other events: 46 other events
Deaths: 0 deaths
Placebo
Serious events: 6 serious events
Other events: 41 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
500 IU qd
n=59 participants at risk
500 IU Interferon-alpha lozenge taken once per day plus 2 placebo lozenges per day
|
500 IU Tid
n=53 participants at risk
500 IU interferon-alpha lozenge taken 3 times per day
|
Placebo
n=57 participants at risk
placebo lozenges taken 3 times per day
|
|---|---|---|---|
|
Infections and infestations
Fever and loss of consciousness
|
1.7%
1/59 • Number of events 1 • 48 weeks
|
0.00%
0/53 • 48 weeks
|
0.00%
0/57 • 48 weeks
|
|
Gastrointestinal disorders
Esophageal ulcers with bleeding
|
0.00%
0/59 • 48 weeks
|
1.9%
1/53 • Number of events 1 • 48 weeks
|
0.00%
0/57 • 48 weeks
|
|
Renal and urinary disorders
Urinary Tract Infection
|
0.00%
0/59 • 48 weeks
|
3.8%
2/53 • Number of events 2 • 48 weeks
|
1.8%
1/57 • Number of events 1 • 48 weeks
|
|
Gastrointestinal disorders
Cirrhotic liver nodule
|
0.00%
0/59 • 48 weeks
|
1.9%
1/53 • Number of events 1 • 48 weeks
|
0.00%
0/57 • 48 weeks
|
|
Renal and urinary disorders
Worsening of benign prostate hyperplasia
|
0.00%
0/59 • 48 weeks
|
1.9%
1/53 • Number of events 1 • 48 weeks
|
0.00%
0/57 • 48 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
1.7%
1/59 • Number of events 1 • 48 weeks
|
0.00%
0/53 • 48 weeks
|
0.00%
0/57 • 48 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Influenza
|
0.00%
0/59 • 48 weeks
|
1.9%
1/53 • Number of events 1 • 48 weeks
|
0.00%
0/57 • 48 weeks
|
|
Gastrointestinal disorders
Gastric ulcers and anemia
|
0.00%
0/59 • 48 weeks
|
0.00%
0/53 • 48 weeks
|
1.8%
1/57 • Number of events 1 • 48 weeks
|
|
Nervous system disorders
right knee arthritis with synovitis
|
0.00%
0/59 • 48 weeks
|
0.00%
0/53 • 48 weeks
|
1.8%
1/57 • Number of events 1 • 48 weeks
|
|
Vascular disorders
Right middle cerebral artery infarction
|
0.00%
0/59 • 48 weeks
|
0.00%
0/53 • 48 weeks
|
1.8%
1/57 • Number of events 1 • 48 weeks
|
|
Cardiac disorders
Thoracic aortic aneurysm
|
0.00%
0/59 • 48 weeks
|
0.00%
0/53 • 48 weeks
|
1.8%
1/57 • Number of events 1 • 48 weeks
|
|
Nervous system disorders
Dizziness with associated nausea and vomiting
|
0.00%
0/59 • 48 weeks
|
0.00%
0/53 • 48 weeks
|
1.8%
1/57 • Number of events 1 • 48 weeks
|
Other adverse events
| Measure |
500 IU qd
n=59 participants at risk
500 IU Interferon-alpha lozenge taken once per day plus 2 placebo lozenges per day
|
500 IU Tid
n=53 participants at risk
500 IU interferon-alpha lozenge taken 3 times per day
|
Placebo
n=57 participants at risk
placebo lozenges taken 3 times per day
|
|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Pruritus
|
15.3%
9/59 • Number of events 9 • 48 weeks
|
11.3%
6/53 • Number of events 6 • 48 weeks
|
12.3%
7/57 • Number of events 8 • 48 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Tract Infection
|
11.9%
7/59 • Number of events 7 • 48 weeks
|
18.9%
10/53 • Number of events 11 • 48 weeks
|
7.0%
4/57 • Number of events 4 • 48 weeks
|
|
Nervous system disorders
Insomnia
|
10.2%
6/59 • Number of events 6 • 48 weeks
|
11.3%
6/53 • Number of events 6 • 48 weeks
|
10.5%
6/57 • Number of events 8 • 48 weeks
|
|
Nervous system disorders
Headache
|
8.5%
5/59 • Number of events 7 • 48 weeks
|
7.5%
4/53 • Number of events 4 • 48 weeks
|
10.5%
6/57 • Number of events 6 • 48 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.5%
5/59 • Number of events 5 • 48 weeks
|
7.5%
4/53 • Number of events 5 • 48 weeks
|
3.5%
2/57 • Number of events 3 • 48 weeks
|
|
Gastrointestinal disorders
Abdominal Distension
|
6.8%
4/59 • Number of events 4 • 48 weeks
|
1.9%
1/53 • Number of events 1 • 48 weeks
|
3.5%
2/57 • Number of events 2 • 48 weeks
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
6.8%
4/59 • Number of events 4 • 48 weeks
|
3.8%
2/53 • Number of events 2 • 48 weeks
|
8.8%
5/57 • Number of events 5 • 48 weeks
|
|
Gastrointestinal disorders
Constipation
|
6.8%
4/59 • Number of events 4 • 48 weeks
|
1.9%
1/53 • Number of events 1 • 48 weeks
|
5.3%
3/57 • Number of events 3 • 48 weeks
|
|
Vascular disorders
Hypertension
|
6.8%
4/59 • Number of events 4 • 48 weeks
|
0.00%
0/53 • 48 weeks
|
1.8%
1/57 • Number of events 1 • 48 weeks
|
|
Gastrointestinal disorders
Diarrhea
|
5.1%
3/59 • Number of events 3 • 48 weeks
|
3.8%
2/53 • Number of events 2 • 48 weeks
|
5.3%
3/57 • Number of events 3 • 48 weeks
|
|
Gastrointestinal disorders
Irritable Bowel Syndrome
|
5.1%
3/59 • Number of events 3 • 48 weeks
|
0.00%
0/53 • 48 weeks
|
7.0%
4/57 • Number of events 4 • 48 weeks
|
|
Renal and urinary disorders
Nephrolithiasis
|
5.1%
3/59 • Number of events 3 • 48 weeks
|
1.9%
1/53 • Number of events 1 • 48 weeks
|
1.8%
1/57 • Number of events 1 • 48 weeks
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.1%
3/59 • Number of events 3 • 48 weeks
|
1.9%
1/53 • Number of events 1 • 48 weeks
|
1.8%
1/57 • Number of events 1 • 48 weeks
|
|
Renal and urinary disorders
Bile Duct Stone
|
3.4%
2/59 • Number of events 2 • 48 weeks
|
1.9%
1/53 • Number of events 1 • 48 weeks
|
5.3%
3/57 • Number of events 3 • 48 weeks
|
|
Nervous system disorders
Dizziness
|
3.4%
2/59 • Number of events 2 • 48 weeks
|
5.7%
3/53 • Number of events 3 • 48 weeks
|
1.8%
1/57 • Number of events 1 • 48 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.7%
1/59 • Number of events 1 • 48 weeks
|
0.00%
0/53 • 48 weeks
|
5.3%
3/57 • Number of events 3 • 48 weeks
|
|
General disorders
Malaise
|
1.7%
1/59 • Number of events 1 • 48 weeks
|
3.8%
2/53 • Number of events 2 • 48 weeks
|
7.0%
4/57 • Number of events 4 • 48 weeks
|
|
Cardiac disorders
Palpitations
|
1.7%
1/59 • Number of events 1 • 48 weeks
|
5.7%
3/53 • Number of events 3 • 48 weeks
|
0.00%
0/57 • 48 weeks
|
|
Gastrointestinal disorders
Dry Mouth
|
0.00%
0/59 • 48 weeks
|
1.9%
1/53 • Number of events 1 • 48 weeks
|
5.3%
3/57 • Number of events 3 • 48 weeks
|
|
General disorders
Fatigue
|
0.00%
0/59 • 48 weeks
|
5.7%
3/53 • Number of events 3 • 48 weeks
|
0.00%
0/57 • 48 weeks
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.00%
0/59 • 48 weeks
|
5.7%
3/53 • Number of events 3 • 48 weeks
|
0.00%
0/57 • 48 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Nasopharyngitis
|
0.00%
0/59 • 48 weeks
|
5.7%
3/53 • Number of events 3 • 48 weeks
|
0.00%
0/57 • 48 weeks
|
|
Renal and urinary disorders
Urinary Tract Infection
|
0.00%
0/59 • 48 weeks
|
5.7%
3/53 • Number of events 3 • 48 weeks
|
1.8%
1/57 • Number of events 1 • 48 weeks
|
Additional Information
Martin J. Cummins, Director of Clinical & Regulatory Affairs
Amarillo Biosciences, Inc.
Phone: 806-376-1741
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place