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

Hepatitis C, Chronic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01830127
• Other study ID #: 1241.30
• Secondary ID: 2012-003534-17
• Status: Completed
• Phase: Phase 2
• First received: March 22, 2013
• Last updated: October 20, 2015
• Start date: April 2013
• Est. completion date: October 2014

Study information

• Verified date: October 2015
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical DevicesSpain: Spanish Agency of MedicinesUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• Ribavirin
24 Weeks
• BI 207127 high dose
24 Weeks
• Faldaprevir
24 Weeks
• Ribavirin
24 Weeks
• BI 207127 low dose
24 Weeks
• Faldaprevir
24 Weeks

Locations

Country	Name	City	State
Germany	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	Hannover
Germany	1241.30.49003 Boehringer Ingelheim Investigational Site	Leipzig
Germany	1241.30.49007 Boehringer Ingelheim Investigational Site	Mainz
Spain	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)
United Kingdom	1241.30.44002 Boehringer Ingelheim Investigational Site	London
United States	1241.30.10011 Boehringer Ingelheim Investigational Site	Arlington	Texas
United States	1241.30.10001 Boehringer Ingelheim Investigational Site	Deland	Florida
United States	1241.30.10003 Boehringer Ingelheim Investigational Site	La Mesa	California
United States	1241.30.10002 Boehringer Ingelheim Investigational Site	Norfolk	Virginia
United States	1241.30.10007 Boehringer Ingelheim Investigational Site	San Diego	California
United States	1241.30.10012 Boehringer Ingelheim Investigational Site	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Countries where clinical trial is conducted

United States,  Germany,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	SVR4: Plasma HCV RNA Level Less Than 25 IU/mL at 4 Weeks After End of Treatment (EOT)	Sustained virologic response (SVR) at Week 4 post-treatment (SVR4): Plasma Hepatitis C virus Ribonucleic acid (HCV RNA) level <25 IU/mL at 4 weeks after EOT. SVR4 was analyzed in a descriptive manner using percentage.	4 weeks after End of Treatment	No

External Links

•   Link