Status:
COMPLETED
A Phase 1b/2a Study of SC Hanferon™ in Combination With Ribavirin in Treatment-naïve Subjects With Genotype 1 Hepatitis C
Lead Sponsor:
HanAll BioPharma Co., Ltd.
Conditions:
Chronic Hepatitis C Infection
Genotype 1
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
PHASE2
Brief Summary
This is an open-label, randomized, safety, tolerability, dose-finding, PK/PD, and preliminary efficacy study of subcutaneous Hanferon™ in combination with ribavirin(RBV) in treatment-naïve subjects wi...
Detailed Description
The primary objective of this study is to evaluate the safety and tolerability of ascending doses of Hanferon™ in combination with ribavirin (RBV). The secondary objective of this study is to define ...
Eligibility Criteria
Inclusion
- Diagnosis of chronic hepatitis C genotype 1a or 1b
- Male or female aged 18 to 65 years, inclusive
- Compensated liver disease without evidence of cirrhosis
- No evidence of type 1 or 2 diabetes mellitus, lipodystrophy or polycystic ovary syndrome
- No history or presence of autoimmune or lymphoproliferative disease or hemoglobinopathies
- Stable medication doses for 1 month for the chronic disease if subjects have chronic diseases, including but not limited to hypertension and dyslipidemia
Exclusion
- History of previous treatment of hepatitis C
- Currently use medication for psychiatric illness including depression, suicidal ideation, and psychosis
- History or presence of chronic liver disease
- History of drug or alcohol abuse within the past year
- Evidence of active illicit drug use
- Clinically significant abnormal electrocardiogram (ECG) or rhythm strip
- Female subject who has a positive urine pregnancy test or who is lactating
Key Trial Info
Start Date :
June 23 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 28 2011
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01194037
Start Date
June 23 2011
End Date
November 28 2011
Last Update
April 22 2025
Active Locations (6)
Enter a location and click search to find clinical trials sorted by distance.
1
Los Angeles, California, United States, 90036
2
National City, California, United States
3
Miami, Florida, United States
4
Atlanta, Georgia, United States