Interferon-alpha Lozenges for Prevention of Relapse in Hepatitis C

January 29, 2024 updated by: Ainos, Inc. (f/k/a Amarillo Biosciences Inc.

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

169

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Changhua, Taiwan
        • Show-Chwan Memorial Hospital
      • Chiayi City, Taiwan
        • Chiayi Christian Hospital
      • Chiayi City, Taiwan
        • Chiayi Chang Gung Memorial Hospital
      • Keelung, Taiwan
        • Keelung Chang Gung Memorial Hospital
      • Taichung, Taiwan
        • China Medical University Hospital
      • Taipei, Taiwan, 105
        • Chang Gung memorial hospital
      • Taipei City, Taiwan
        • Taipei Veterans General Hospital
    • Chiayi County
      • Dalin, Chiayi County, Taiwan
        • Dalin Buddhist Tzu Chi General Hospital
    • Kaosiung County
      • Niaosong, Kaosiung County, Taiwan
        • Kaohsiung Chang Gung Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 500 IU qd
500 IU Interferon-alpha lozenge taken once per day plus 2 placebo lozenges per day
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
Other Names:
  • IFN-alpha
  • Veldona lozenges
  • oral interferon
  • IFN-alpha lozenges
  • oral interferon lozenges
Experimental: 500 IU tid
500 IU interferon-alpha lozenge taken 3 times per day
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
Other Names:
  • IFN-alpha
  • Veldona lozenges
  • oral interferon
  • IFN-alpha lozenges
  • oral interferon lozenges
Placebo Comparator: placebo
placebo lozenges taken 3 times per day
Drug: placebo lozenges
200 mg matching placebo lozenges
Other Names:
  • sugar pills

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Relapse Rate
Time Frame: 48 weeks

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.
48 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sustained Virologic Response Rate
Time Frame: 48 weeks
Percentage of participants who remained HCV RNA negative throughout the study
48 weeks
Normalization of ALT
Time Frame: 48 weeks
Percentage of participants with a normal serum ALT level at the end of the study
48 weeks
Change in Serum HCV RNA Concentration
Time Frame: 48 weeks
Change in serum HCV RNA concentration (log10 IU) from baseline to week 48
48 weeks
Change in Serum ALT
Time Frame: 48 weeks
Change in Serum ALT concentration from baseline to week 48
48 weeks
Change in Social Functioning
Time Frame: 48 weeks

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.
48 weeks
Change in Fibrotest Score
Time Frame: 48 weeks
Change in fibrotest score from baseline to week 48
48 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Collaborators

CytoPharm, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (Actual)

November 1, 2011

Study Completion (Actual)

February 1, 2012

Study Registration Dates

First Submitted

June 9, 2008

First Submitted That Met QC Criteria

June 10, 2008

First Posted (Estimated)

June 11, 2008

Study Record Updates

Last Update Posted (Estimated)

February 21, 2024

Last Update Submitted That Met QC Criteria

January 29, 2024

Last Verified

August 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 07HWHC09

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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