Title
Interferon-alpha Lozenges for Prevention of Relapse in Hepatitis C
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
Phase
Phase 2Lead Sponsor
Amarillo Biosciences, Inc.Study Type
InterventionalStatus
Completed Results PostedIndication/Condition
Hepatitis C, ChronicIntervention/Treatment
interferon alpha-2b ...Study Participants
169The 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.
500 IU lozenges of natural human interferon-alpha for oral dissolution given once or three times per day for 24 weeks
200 mg matching placebo lozenges
500 IU Interferon-alpha lozenge taken once per day plus 2 placebo lozenges per day
500 IU interferon-alpha lozenge taken 3 times per day
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
| Event Type | Organ System | Event Term | 500 IU qd | 500 IU Tid | Placebo |
|---|
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.
Percentage of participants with a normal serum ALT level at the end of the study
Change in serum HCV RNA concentration (log10 IU) from baseline to week 48
Change in Serum ALT concentration from baseline to week 48
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.
Change in fibrotest score from baseline to week 48
Percentage of participants who remained HCV RNA negative throughout the study
Percentage of participants with a low platelet count at baseline who had a normal platelet count at the end of the study
