Interferon-alpha Lozenges for Prevention of Relapse in Hepatitis C

Hepatitis C, Chronic Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00695019
• Other study ID #: 07HWHC09
• Status: Completed
• Phase: Phase 2
• Start date: June 2009
• Est. completion date: February 2012

Study information

• Verified date: August 2013
• Source: Ainos, Inc. (f/k/a Amarillo Biosciences Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 169
• Est. completion date: February 2012
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic

Intervention

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
• placebo lozenges
200 mg matching placebo lozenges

Locations

Country	Name	City	State
Taiwan	Show-Chwan Memorial Hospital	Changhua
Taiwan	Chiayi Chang Gung Memorial Hospital	Chiayi City
Taiwan	Chiayi Christian Hospital	Chiayi City
Taiwan	Dalin Buddhist Tzu Chi General Hospital	Dalin	Chiayi County
Taiwan	Keelung Chang Gung Memorial Hospital	Keelung
Taiwan	Kaohsiung Chang Gung Memorial Hospital	Niaosong	Kaosiung County
Taiwan	China Medical University Hospital	Taichung
Taiwan	Chang Gung Memorial Hospital	Taipei
Taiwan	Taipei Veterans General Hospital	Taipei City

Sponsors (2)

Lead Sponsor	Collaborator
Ainos, Inc. (f/k/a Amarillo Biosciences Inc.	CytoPharm, Inc.

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	48 weeks
Secondary	Sustained Virologic Response Rate	Percentage of participants who remained HCV RNA negative throughout the study	48 weeks
Secondary	Normalization of ALT	Percentage of participants with a normal serum ALT level at the end of the study	48 weeks
Secondary	Change in Serum HCV RNA Concentration	Change in serum HCV RNA concentration (log10 IU) from baseline to week 48	48 weeks
Secondary	Change in Serum ALT	Change in Serum ALT concentration from baseline to week 48	48 weeks
Secondary	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.	48 weeks
Secondary	Change in Fibrotest Score	Change in fibrotest score from baseline to week 48	48 weeks