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

A phase II 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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-003534-17-ES

Enrollment

165

Registered

2013-01-09

Start date

2013-04-05

Completion date

Unknown

Last updated

2014-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Hepatitis C Infection

Interventions

Product Name: BI 207127 NA / 200mg Pharmaceutical Form: Film-coated tablet INN or Proposed INN: n.a. Current Sponsor code: BI 207127 NA Concentration unit: mg milligram(s) Concentration type: equal Co

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Treatment naïve and 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. 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 120 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 45

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Main Objective: The objective of Cohort A is to evaluate the safety and pharmacokinetic (PK) profile of BI 207127 (potentially two doses) 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]) to define the BI 207127 dose to be used in Cohort B. The objective of Cohort B is to assess efficacy, safety, and pharmacokinetics of 24-week treatment of the BI 207127 dose selected in Cohort A in combination with 120 mg once daily (q.d.) FDV and weight ?based RBV in a larger group of chronically infected HCV GT1b patients with moderate hepatic impairment (CPB).;Secondary Objective: Not applicable.;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).;Timepoint(s) of evaluation of this end point: The primary endpoint is at 12 weeks after EOT.	—

Measure

Time frame

Main Objective: The objective of Cohort A is to evaluate the safety and pharmacokinetic (PK) profile of BI 207127 (potentially two doses) 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]) to define the BI 207127 dose to be used in Cohort B. The objective of Cohort B is to assess efficacy, safety, and pharmacokinetics of 24-week treatment of the BI 207127 dose selected in Cohort A in combination with 120 mg once daily (q.d.) FDV and weight ?based RBV in a larger group of chronically infected HCV GT1b patients with moderate hepatic impairment (CPB).;Secondary Objective: Not applicable.;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).;Timepoint(s) of evaluation of this end point: The primary endpoint is at 12 weeks after EOT.

—

Secondary

Measure	Time frame
Secondary end point(s): Secondary efficacy endpoints: ? SVR4: Plasma HCV RNA level <25 IU/mL at 4 weeks after EOT ? SVR24: Plasma HCV RNA level <25 IU/mL at 24 weeks after EOT;Timepoint(s) of evaluation of this end point: at 4 weeks after EOT and 24 weeks after EOT	—

Countries

France, Germany, Ireland, Italy, Netherlands, Spain, Switzerland, United Kingdom

Contacts

Public ContactQRPE PSC CT Information Disclosure

Boehringer Ingelheim Pharma GmbH & Co. KG

clintriage.rdg@boehringer-ingelheim.com+18002430127

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026