Status:
COMPLETED
Interferon-alpha Lozenges for Prevention of Relapse in Hepatitis C
Lead Sponsor:
Ainos, Inc. (f/k/a Amarillo Biosciences Inc.
Collaborating Sponsors:
CytoPharm, Inc.
Conditions:
Hepatitis C, Chronic
Eligibility:
All Genders
21+ years
Phase:
PHASE2
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 virol...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2012
Estimated Enrollment :
169 Patients enrolled
Trial Details
Trial ID
NCT00695019
Start Date
June 1 2009
End Date
February 1 2012
Last Update
February 21 2024
Active Locations (9)
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1
Dalin Buddhist Tzu Chi General Hospital
Dalin, Chiayi County, Taiwan
2
Kaohsiung Chang Gung Memorial Hospital
Niaosong, Kaosiung County, Taiwan
3
Show-Chwan Memorial Hospital
Changhua, Taiwan
4
Chiayi Chang Gung Memorial Hospital
Chiayi City, Taiwan