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

07HWHC09

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.

2009-06-01

2011-11-01

2012-02-01

Completed

Early phase I

169

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 169, 'type': 'ACTUAL'}}

2024-02-21