Interferon-alpha Lozenges for Prevention of Relapse in Hepatitis C

Study Overview
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Brief Summary
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The purpose of this study is to determine whether lozenges of interferon-alpha that are dissolved in the mouth can prevent relapse in patients with hepatitis C virus infection who had a complete virologic response after receiving a combination of injected interferon-alpha and oral ribavirin.

Official Title
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A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Low-Dose Human Interferon-alpha by the Oral Mucosal Route During the 6-Month Follow-up Period of Standard Combination Therapy for Hepatitis C Virus Infection

Conditions
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Hepatitis C, Chronic

Intervention / Treatment
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* Drug: interferon-alpha lozenges
* Drug: placebo lozenges


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: HCV genotype 1b Will be completing pegylated IFN-alpha and ribavirin therapy within 4 weeks Serum HCV RNA negative within 4 weeks of study entry Exclusion Criteria: Child-Pugh score of B or C Decompensated liver function History of malignancy within past 5 years Other causes of liver disease besides HCV infection Uncontrolled diabetes or hypertension Unwilling to use two forms of birth control during study treatment

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 500 IU qd<br>500 IU Interferon-alpha lozenge taken once per day plus 2 placebo lozenges per day | Drug: interferon-alpha lozenges<br>* 500 IU lozenges of natural human interferon-alpha for oral dissolution given once or three times per day for 24 weeks<br>* Other names: oral interferon lozenges;|
| Experimental: 500 IU tid<br>500 IU interferon-alpha lozenge taken 3 times per day | Drug: interferon-alpha lozenges<br>* 500 IU lozenges of natural human interferon-alpha for oral dissolution given once or three times per day for 24 weeks<br>* Other names: oral interferon lozenges;|
| Placebo Comparator: placebo<br>placebo lozenges taken 3 times per day | Drug: placebo lozenges<br>* 200 mg matching placebo lozenges<br>* Other names: sugar pills;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relapse Rate | 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. | 48 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sustained Virologic Response Rate | Percentage of participants who remained HCV RNA negative throughout the study | 48 weeks | 
| Normalization of ALT | Percentage of participants with a normal serum ALT level at the end of the study | 48 weeks | 
| Change in Serum HCV RNA Concentration | Change in serum HCV RNA concentration (log10 IU) from baseline to week 48 | 48 weeks | 
| Change in Serum ALT | Change in Serum ALT concentration from baseline to week 48 | 48 weeks | 
| Change in Social Functioning | 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. | 48 weeks | 
| Change in Fibrotest Score | Change in fibrotest score from baseline to week 48 | 48 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prevention of Relapse, HCV genotype 1b, Recurrence