Trials / Completed
CompletedNCT00695019
Interferon-alpha Lozenges for Prevention of Relapse in Hepatitis C
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
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 169 (actual)
- Sponsor
- Ainos, Inc. (f/k/a Amarillo Biosciences Inc. · Industry
- Sex
- All
- Age
- 21 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | interferon-alpha lozenges | 500 IU lozenges of natural human interferon-alpha for oral dissolution given once or three times per day for 24 weeks |
| DRUG | placebo lozenges | 200 mg matching placebo lozenges |
Timeline
- Start date
- 2009-06-01
- Primary completion
- 2011-11-01
- Completion
- 2012-02-01
- First posted
- 2008-06-11
- Last updated
- 2024-02-21
- Results posted
- 2013-10-31
Locations
9 sites across 1 country: Taiwan
Source: ClinicalTrials.gov record NCT00695019. Inclusion in this directory is not an endorsement.