BI 207127 / faldaprevir combination therapy in hepatic impairment (Child-Pugh B) patients with genotype 1b chronic hepatitis C infectio

Phase 1

• Conditions: Chronic Hepatitis C Infection; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2012-003534-17-GB
• Lead Sponsor: Boehringer Ingelheim Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-01-21
• Study Completion: 2014-10-21
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 64

Inclusion Criteria

Treatment naïve,treatment experienced patients to an approved PegIFN/RBV regimen (prior relapse, interferon intolerant, and [allowed in Cohort A only] prior partial response) and treatment experienced to interferon not as part of an approved pegIFN/RBV regimen.
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.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 26
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 4

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Main Objective: The objective of Cohort A is to evaluate the safety and pharmacokinetic (PK) profile of BI 207127 in combination with 120 mg once daily (q.d.) FDV and weight-based RBV in a small group of patients with moderate hepatic impairment (Child-Pugh B [CPB]) compared to patients with mild hepatic impairment (Child-Pugh A [CPA]).<br> <br> ;Secondary Objective: Not applicable.;<br> Primary end point(s): The primary endpoint is Sustained Virologic Response at Week 12 post-treatment (SVR12): Plasma HCV RNA level <25 IU/mL at 12 weeks after EOT (End of Treatment).<br> ;<br> Timepoint(s) of evaluation of this end point: The primary endpoint is at at 12 weeks after EOT.<br>

Secondary Outcome Measures

Name	Time	Method
<br> Secondary end point(s): Secondary efficacy endpoints:<br> • SVR4: Plasma HCV RNA level <25 IU/mL at 4 weeks after EOT<br> <br> ;Timepoint(s) of evaluation of this end point: AT 4 weeks after EOT and 24 weeks after EOT