Interferon-alpha Lozenges for Prevention of Relapse in Hepatitis C

Phase 2

Completed

• Conditions: Hepatitis C, Chronic
• Interventions: Drug: interferon-alpha lozenges; Drug: placebo lozenges

• Registration Number: NCT00695019
• Lead Sponsor: Ainos, Inc. (f/k/a Amarillo Biosciences Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-06-09
• Study First Submitted QC: 2008-06-10
• Study First Posted: 2008-06-11
• Study Start: 2009-06
• Primary Completion: 2011-11
• Study Completion: 2012-02
• Results First Submitted: 2013-02-05
• Status Verified: 2013-08
• Results First Submitted QC: 2013-08-27
• Results First Posted: 2013-10-31
• Last Update Submitted: 2024-01-29
• Last Update Posted: 2024-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 169

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
500 IU qd	interferon-alpha lozenges	500 IU Interferon-alpha lozenge taken once per day plus 2 placebo lozenges per day
500 IU tid	interferon-alpha lozenges	500 IU interferon-alpha lozenge taken 3 times per day
placebo	placebo lozenges	placebo lozenges taken 3 times per day

Primary Outcome Measures

Name	Time	Method
Relapse Rate	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 Outcome Measures

Name	Time	Method
Sustained Virologic Response Rate	48 weeks	Percentage of participants who remained HCV RNA negative throughout the study
Normalization of ALT	48 weeks	Percentage of participants with a normal serum ALT level at the end of the study
Change in Serum HCV RNA Concentration	48 weeks	Change in serum HCV RNA concentration (log10 IU) from baseline to week 48
Change in Serum ALT	48 weeks	Change in Serum ALT concentration from baseline to week 48
Change in Fibrotest Score	48 weeks	Change in fibrotest score from baseline to week 48
Change in Social Functioning	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.

Trial Locations

Locations (9)

Dalin Buddhist Tzu Chi General Hospital; 🇨🇳 Dalin, Chiayi County, Taiwan

Kaohsiung Chang Gung Memorial Hospital; 🇨🇳 Niaosong, Kaosiung County, Taiwan

Show-Chwan Memorial Hospital; 🇨🇳 Changhua, Taiwan

Chiayi Chang Gung Memorial Hospital; 🇨🇳 Chiayi City, Taiwan

Chiayi Christian Hospital; 🇨🇳 Chiayi City, Taiwan

Keelung Chang Gung Memorial Hospital; 🇨🇳 Keelung, Taiwan

China Medical University Hospital; 🇨🇳 Taichung, Taiwan

Taipei Veterans General Hospital; 🇨🇳 Taipei City, Taiwan

Chang Gung Memorial Hospital; 🇨🇳 Taipei, Taiwan