Status:
COMPLETED
BI 207127 / Faldaprevir Combination Therapy in Hepatic Impairment (Child-Pugh B) Patients With Genotype 1b Chronic Hepatitis C Infection: HCVerso3
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Hepatitis C, Chronic
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
To assess the pharmacokenetic characteristics of 600 mg BID BI 207127 / 120 mg QD faldaprevir /ribavirin in a small number of GT1b HCV infected patients with mild hepatic impairment (CPA) (Arm 1) vers...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Treatment naïve and treatment experienced patients (prior relapse, interferon intolerant, and \[allowed in Cohort A only\] prior partial response).
- Chronic HCV infection of genotype 1 (GT1), sub-GT1b virus only.
- Liver cirrhosis defined as Metavir Grade=4 or Ishak Grade =5 on liver biopsy or liver stiffness of =13 kPa on fibroscan.
- Exclusion criteria:
- HCV infection of mixed genotype (1/2, 1/3, and 1/4) or mixed sub-GT1a/1b or undefined diagnosed by genotypic testing at screening
- Liver disease due to causes other than chronic HCV infection which may include but is not limited to hemochromatosis, Wilson's disease, or autoimmune liver diseases.
- HIV infection
- Patients who have been previously treated with an investigational or approved DAA
Exclusion
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2014
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT01830127
Start Date
April 1 2013
End Date
October 1 2014
Last Update
November 20 2015
Active Locations (19)
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1
1241.30.10003 Boehringer Ingelheim Investigational Site
La Mesa, California, United States
2
1241.30.10007 Boehringer Ingelheim Investigational Site
San Diego, California, United States
3
1241.30.10001 Boehringer Ingelheim Investigational Site
DeLand, Florida, United States
4
1241.30.10012 Boehringer Ingelheim Investigational Site
West Palm Beach, Florida, United States