At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 169 enrolled
Drug / intervention
interferon-alpha lozenges +1 moredrug
Likely dose
interferon-alpha lozenges 500 IUfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
Ainos, Inc. (f/k/a Amarillo Biosciences Inc.·interventional·Posted Jun 11, 2008·Updated Feb 21, 2024
In Brief
A Phase 2 clinical trial evaluating interferon-alpha lozenges and placebo lozenges for Hepatitis C, Chronic. Completed, enrolled 169 participants across 9 sites.
Detailed Summary
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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis C, Chronic
CountriesTaiwan
CollaboratorsCytoPharm, Inc.
Timeline
Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 2008
Enrollment StartJun 2009
Primary CompletionNov 2011
Study CompletionFeb 2012
TodayJul 2026
First PostedJun 11, 2008
Enrollment StartJun 1, 2009
Primary CompletionNov 1, 2011
Study CompletionFeb 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 18.1 years ago
Interventions
interferon-alpha lozengesdrug
500 IU lozenges of natural human interferon-alpha for oral dissolution given once or three times per day for 24 weeks
placebo lozengesdrug
200 mg matching placebo lozenges