Status:
COMPLETED
A Phase 3 Study in Combination With BMS-790052 and BMS-650032 in Japanese Hepatitis C Virus (HCV) Patients
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Hepatitis C
Eligibility:
All Genders
20-75 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to assess the anti-viral activity of BMS-790052 and BMS-650032 combination therapy in Japanese subjects.
Eligibility Criteria
Inclusion
- Chronic HCV-1b infected patient
- HCV RNA viral load of ≥ 100,000 IU/mL at screening
- Ages 20 to 75 years
- Non-responder to Interferon plus Ribavirin therapy
- Patient who has been excluded from interferon/ribavirin therapy or intolerant for Interferon/Ribavirin therapy
Exclusion
- Patients who have -
- Hepatocellular carcinoma
- Co-infection with Hepatitis B virus (HBV) or Human Immunodeficiency Virus (HIV)
- Severe or uncontrollable complication
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
224 Patients enrolled
Trial Details
Trial ID
NCT01497834
Start Date
January 1 2012
End Date
June 1 2013
Last Update
October 9 2015
Active Locations (24)
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1
Local Institution
Nagoya, Aichi-ken, Japan, 4668560
2
Local Institution
Chiba, Chiba, Japan, 2608677
3
Local Institution
Fukuoka, Fukuoka, Japan, 8108563
4
Local Institution
Kurume, Fukuoka, Japan, 8300011