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Phase 2 N=35 Treatment

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

Hepatitis C, Chronic

Bottom Line

View on ClinicalTrials.gov: NCT01830127 ↗
Enrolled (actual)
35
Serious AEs
28.6%
Results posted
Nov 2015
Primary outcome: Primary: SVR12: Plasma HCV RNA Level Less Than 25 IU/mL at 12 Weeks After End of Treatment (EOT) — 61.1; 52.9 Percentage of participants

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
Ribavirin (Drug); BI 207127 high dose (Drug); Faldaprevir (Drug); BI 207127 low dose (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Boehringer Ingelheim
Primary completion
Oct 2014

Outcome Measures

OutcomeResultp-value
PRIMARY
SVR12: Plasma HCV RNA Level Less Than 25 IU/mL at 12 Weeks After End of Treatment (EOT)		 61.1; 52.9 —
SECONDARY
SVR4: Plasma HCV RNA Level Less Than 25 IU/mL at 4 Weeks After End of Treatment (EOT)		 72.2; 76.5 —

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).

Eligibility Criteria

Inclusion criteria

  • Treatment naïve and treatment 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.

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01830127). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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