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Completed

NCT Number: NCT00695019

Interferon-alpha Lozenges for Prevention of Relapse in Hepatitis C

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.

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Key information

Conditions

Hepatitis C, Chronic Blood-Borne Infections Chronic Disease Communicable Diseases Digestive System Diseases Disease Attributes Flaviviridae Infections Hepatitis Hepatitis C Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Recurrence Virus Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Dalin Buddhist Tzu Chi General Hospital, Dalin, Chiayi County, Taiwan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

interferon-alpha lozenges

Drug

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 lozenges

Drug

200 mg matching placebo lozenges

Other names: sugar pills

Primary outcomes

  1. 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.

Secondary outcomes

  1. Sustained Virologic Response Rate

    Time frame: 48 weeks

    Percentage of participants who remained HCV RNA negative throughout the study

  2. Normalization of ALT

    Time frame: 48 weeks

    Percentage of participants with a normal serum ALT level at the end of the study

  3. Change in Serum HCV RNA Concentration

    Time frame: 48 weeks

    Change in serum HCV RNA concentration (log10 IU) from baseline to week 48

  4. Change in Serum ALT

    Time frame: 48 weeks

    Change in Serum ALT concentration from baseline to week 48

  5. 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.

  6. Change in Fibrotest Score

    Time frame: 48 weeks

    Change in fibrotest score from baseline to week 48

Sponsors and collaborators

Lead sponsor

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

Industry

Collaborators

  • CytoPharm, Inc.

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2011
Study completion
2012
First posted
Jun 11, 2008
Registry last updated
Feb 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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