BI 207127 / Faldaprevir Combination Therapy in Hepatic Impairment (Child-Pugh B) Patients With Genotype 1b Chronic Hepatitis C Infection: HCVerso3
A Phase IIb Open Label Study of BI 207127 in Combination With Faldaprevir and Ribavirin in Patients With Moderate Hepatic Impairment (Child-Pugh B) With Genotype 1b Chronic Hepatitis C Infection
2 other identifiers
interventional
35
4 countries
19
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) versus 400 mg BID BI 207127 / 120 mg QD faldaprevir /ribavirin in a small number of GT1b HCV infected patients with moderate hepatic impairment (CPB) (Arm 2).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Apr 2013
Shorter than P25 for phase_2
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 22, 2013
CompletedStudy Start
First participant enrolled
April 1, 2013
CompletedFirst Posted
Study publicly available on registry
April 12, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2014
CompletedResults Posted
Study results publicly available
November 20, 2015
CompletedNovember 20, 2015
October 1, 2015
1.5 years
March 22, 2013
October 20, 2015
October 20, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
SVR12: Plasma HCV RNA Level Less Than 25 IU/mL at 12 Weeks After End of Treatment (EOT)
Sustained virologic response (SVR) at Week 12 post-treatment (SVR12): Plasma Hepatitis C virus Ribonucleic acid (HCV RNA) level \<25 IU/mL(international units per millilitre) at 12 weeks after EOT. SVR12 was analyzed in a descriptive manner using percentage.
12 weeks after End of Treatment
Secondary Outcomes (1)
SVR4: Plasma HCV RNA Level Less Than 25 IU/mL at 4 Weeks After End of Treatment (EOT)
4 weeks after End of Treatment
Study Arms (2)
cohort A CPA
EXPERIMENTALCohort A CPA BI 207127/QD Faldaprevir Ribavirin
cohort A CPB
EXPERIMENTALCohort B CPB BI 207127/QD Faldaprevir Ribavirin
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (19)
1241.30.10003 Boehringer Ingelheim Investigational Site
La Mesa, California, United States
1241.30.10007 Boehringer Ingelheim Investigational Site
San Diego, California, United States
1241.30.10001 Boehringer Ingelheim Investigational Site
DeLand, Florida, United States
1241.30.10012 Boehringer Ingelheim Investigational Site
West Palm Beach, Florida, United States
1241.30.10011 Boehringer Ingelheim Investigational Site
Arlington, Texas, United States
1241.30.10002 Boehringer Ingelheim Investigational Site
Norfolk, Virginia, United States
1241.30.49002 Boehringer Ingelheim Investigational Site
Berlin, Germany
1241.30.49004 Boehringer Ingelheim Investigational Site
Berlin, Germany
1241.30.49005 Boehringer Ingelheim Investigational Site
Berlin, Germany
1241.30.49008 Boehringer Ingelheim Investigational Site
Bonn, Germany
1241.30.49006 Boehringer Ingelheim Investigational Site
Frankfurt am Main, Germany
1241.30.49001 Boehringer Ingelheim Investigational Site
Hanover, Germany
1241.30.49003 Boehringer Ingelheim Investigational Site
Leipzig, Germany
1241.30.49007 Boehringer Ingelheim Investigational Site
Mainz, Germany
1241.30.34002 Boehringer Ingelheim Investigational Site
Barcelona, Spain
1241.30.34005 Boehringer Ingelheim Investigational Site
Barcelona, Spain
1241.30.34003 Boehringer Ingelheim Investigational Site
Madrid, Spain
1241.30.34001 Boehringer Ingelheim Investigational Site
Majadahonda (Madrid), Spain
1241.30.44002 Boehringer Ingelheim Investigational Site
London, United Kingdom
Related Publications (1)
Sarrazin C, Manns M, Calleja JL, Garcia-Samaniego J, Forns X, Kaste R, Bai X, Wu J, Stern JO. HCVerso3: An Open-Label, Phase IIb Study of Faldaprevir and Deleobuvir with Ribavirin in Hepatitis C Virus Genotype-1b-Infected Patients with Cirrhosis and Moderate Hepatic Impairment. PLoS One. 2016 Dec 28;11(12):e0168544. doi: 10.1371/journal.pone.0168544. eCollection 2016.
PMID: 28030579DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Because the company decided to stop the DBV development program, analyses for this trial were limited to the basic requirement for efficacy, and only the primary endpoint and secondary endpoint were analyzed.
Results Point of Contact
- Title
- Boehringer Ingelheim, Call Center
- Organization
- Boehringer Ingelheim
Study Officials
- STUDY CHAIR
Boehringer Ingelheim
Boehringer Ingelheim
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 22, 2013
First Posted
April 12, 2013
Study Start
April 1, 2013
Primary Completion
October 1, 2014
Study Completion
October 1, 2014
Last Updated
November 20, 2015
Results First Posted
November 20, 2015
Record last verified: 2015-10