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BI 207127 / Faldaprevir Combination Therapy in Hepatic Impairment (Child-Pugh B) Patients With Genotype 1b Chronic Hepatitis C Infection: HCVerso3

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01830127
First received: March 22, 2013
Last updated: April 16, 2014
Last verified: April 2014
  Purpose

Cohort A: Objective of Part 1a: 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).

Cohort A: Objective of Part 1b (Arm 3): Part 1b will only be conducted if the pharmacokenetics in Part 1a show that the 400 mg BID BI 207127 / 120 mg QD faldaprevir / ribavirin regimen is inadequate to achieve therapeutic BI207127 and/or faldaprevir levels. Part 1B will 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 moderate hepatic impairment (CPB). If arm 2 in part 1a has similar or higher PK than Arm 1, Part 1b (Arm 3) will be skipped.

Cohort B: Main Objective Part 2: To evaluate the safety, efficacy and PK of treatment with 120 mg of once daily (QD) faldaprevir for 24 weeks in combination with either 400 mg of twice-daily (BID) BI 207127 or 600 mg of BID BI 207127 (depending on the outcome of Part 1) and ribavirin (R) in a larger group of GT1b HCV infected patients with moderate hepatic impairment (CPB).


Condition Intervention Phase
Hepatitis C, Chronic
Drug: Faldaprevir
Drug: BI 207127
Drug: BI 207127 high dose
Drug: Ribavirin placebo
Drug: BI 207127 high dose placebo
Drug: Ribavirin
Drug: Faldaprevir placebo
Drug: BI 207127 low dose
Drug: BI 207127 low dose placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Phase III Randomised, Double-blind and Placebo-controlled 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

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • SVR12: Plasma HCV RNA level less than 25 IU/mL at 12 weeks after End of Treatment [ Time Frame: 12 weeks after End of Treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • SVR4: Plasma HCV RNA level less than 25 IU/mL at 4 weeks after End of Treatment [ Time Frame: 4 weeks after End of Treatment ] [ Designated as safety issue: No ]
  • SVR24: Plasma HCV RNA level less than 25 IU/mL at 24 weeks after End of Treatment [ Time Frame: 24 week after End of Treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 35
Study Start Date: April 2013
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: cohort b active
Cohort B CPB BID BI 207127/QD Faldaprevir and ribavirin
Drug: BI 207127
24 weeks
Drug: Faldaprevir
24 weeks
Experimental: cohort a CPA
Cohort A CPA high dose BID BI 207127/QD Faldaprevir and ribavirin
Drug: BI 207127 high dose
24 weeks
Drug: Ribavirin placebo
24 weeks
Drug: BI 207127 high dose placebo
24 weeks
Drug: Ribavirin
24 weeks
Drug: Faldaprevir placebo
24 weeks
Drug: BI 207127 low dose placebo
24 weeks
Drug: Faldaprevir
24 weeks
Drug: BI 207127 low dose
24 weeks
Experimental: cohort a CPB low dose
Cohort A CPB low dose BID BI 207127/QD Faldaprevir and ribavirin
Drug: Faldaprevir
24 weeks
Drug: BI 207127 low dose
24 weeks
Experimental: cohort a CPB high dose
Cohort A CPB high dose BID BI 207127/QD Faldaprevir and ribavirin
Drug: Faldaprevir
24 weeks
Drug: BI 207127 high dose
24 weeks
Placebo Comparator: cohort b control
Cohort B CPB placebo control
Drug: Faldaprevir
24 weeks
Drug: BI 207127
24 weeks

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  1. Treatment naïve and treatment experienced patients (prior relapse, interferon intolerant, and [allowed in Cohort A only] prior partial response).
  2. Chronic HCV infection of genotype 1 (GT1), sub-GT1b virus only.
  3. Liver cirrhosis defined as Metavir Grade=4 or Ishak Grade =5 on liver biopsy or liver stiffness of =13 kPa on fibroscan.

Exclusion criteria:

  1. 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
  2. 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.
  3. HIV infection
  4. Patients who have been previously treated with an investigational or approved DAA
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01830127

Locations
United States, California
1241.30.10003 Boehringer Ingelheim Investigational Site
La Mesa, California, United States
1241.30.10007 Boehringer Ingelheim Investigational Site
San Diego, California, United States
United States, Florida
1241.30.10001 Boehringer Ingelheim Investigational Site
Deland, Florida, United States
1241.30.10012 Boehringer Ingelheim Investigational Site
West Palm Beach, Florida, United States
United States, Texas
1241.30.10011 Boehringer Ingelheim Investigational Site
Arlington, Texas, United States
United States, Virginia
1241.30.10002 Boehringer Ingelheim Investigational Site
Norfolk, Virginia, United States
Germany
1241.30.49004 Boehringer Ingelheim Investigational Site
Berlin, Germany
1241.30.49002 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
Hannover, Germany
1241.30.49003 Boehringer Ingelheim Investigational Site
Leipzig, Germany
1241.30.49007 Boehringer Ingelheim Investigational Site
Mainz, Germany
Spain
1241.30.34005 Boehringer Ingelheim Investigational Site
Barcelona, Spain
1241.30.34002 Boehringer Ingelheim Investigational Site
Barcelona, Spain
1241.30.34003 Boehringer Ingelheim Investigational Site
Madrid, Spain
1241.30.34001 Boehringer Ingelheim Investigational Site
Madrid, Spain
United Kingdom
1241.30.44002 Boehringer Ingelheim Investigational Site
London, United Kingdom
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01830127     History of Changes
Other Study ID Numbers: 1241.30, 2012-003534-17
Study First Received: March 22, 2013
Last Updated: April 16, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Spain: Spanish Agency of Medicines
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Ribavirin
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 23, 2014