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Interferon-alpha Lozenges for Prevention of Relapse in Hepatitis C

NCT00695019 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 169

Last updated 2024-02-21

Study results available
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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

  • Hepatitis C, Chronic

Interventions

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

Sponsors & Collaborators

  • CytoPharm, Inc.

    collaborator INDUSTRY

  • Ainos, Inc. (f/k/a Amarillo Biosciences Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-06-30
Primary Completion
2011-11-30
Completion
2012-02-29

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00695019 on ClinicalTrials.gov