BI 207127 / faldaprevir combination therapy in hepatic impairment (Child-Pugh B) patients with genotype 1b chronic hepatitis C infectio
- Conditions
- Therapeutic area: Diseases [C] - Virus Diseases [C02]Chronic Hepatitis C Infection
- Registration Number
- EUCTR2012-003534-17-DE
- Lead Sponsor
- Boehringer Ingelheim Pharma GmbH & Co. KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 35
Treatment-naïve patients, or treatment-experienced to an approved PegIFN/RBV regimen (prior relapse, interferon intolerant, and prior partial response), or treatment-experienced to IFN 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 29
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 6
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.
Previous treatment with an investigational or approved direct acting antiviral drug (DAA).
Patients classified as Child Pugh C (score 10-15 points).
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.;Timepoint(s) of evaluation of this end point: The primary endpoint is at 12 weeks after EOT.<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>
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Secondary efficacy endpoints:<br>• SVR4: Plasma HCV RNA level <25 IU/mL at 4 weeks after EOT;Timepoint(s) of evaluation of this end point: At 4 weeks after EOT