Interferon-alpha Lozenges for Prevention of Relapse in Hepatitis C

Ainos, Inc. (f/k/a Amarillo Biosciences Inc.169 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

169

Conditions

Hepatitis C, Chronic

Interventions

interferon-alpha lozengesDRUG

500 IU lozenges of natural human interferon-alpha for oral dissolution given once or three times per day for 24 weeks

placebo lozengesDRUG

200 mg matching placebo lozenges

Eligibility

Sex: ALLMin age: 21 Years

Medical Language ↔ Plain English

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

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

Outcomes

Primary Outcomes

Relapse Rate

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.

Time frame: 48 weeks

Secondary Outcomes

Sustained Virologic Response Rate

Percentage of participants who remained HCV RNA negative throughout the study

Time frame: 48 weeks

Normalization of ALT

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

Time frame: 48 weeks

Change in Serum HCV RNA Concentration

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

Time frame: 48 weeks

Change in Serum ALT

Change in Serum ALT concentration from baseline to week 48

Time frame: 48 weeks

Change in Social Functioning

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.

Time frame: 48 weeks

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.