Clinical trial NCT01830127: BI 207127 / Faldaprevir Combination Therapy in Hepatic Impairment (Child-Pugh B) Patients With Genotype 1b Chronic Hepatitis C Infection: HCVerso3
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hepatitis C, Chronic
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2013-04-12
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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:

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

Primary outcomes:
measure: SVR12: Plasma HCV RNA Level Less Than 25 IU/mL at 12 Weeks After End of Treatment (EOT)
timeFrame: 12 weeks after End of Treatment
Secondary outcomes:
measure: SVR4: Plasma HCV RNA Level Less Than 25 IU/mL at 4 Weeks After End of Treatment (EOT)
timeFrame: 4 weeks after End of Treatment
Other outcomes:
Locations:
city: La Mesa
country: United States
facility: 1241.30.10003 Boehringer Ingelheim Investigational Site
state: California
city: San Diego
country: United States
facility: 1241.30.10007 Boehringer Ingelheim Investigational Site
state: California
city: Deland
country: United States
facility: 1241.30.10001 Boehringer Ingelheim Investigational Site
state: Florida
city: West Palm Beach
country: United States
facility: 1241.30.10012 Boehringer Ingelheim Investigational Site
state: Florida
city: Arlington
country: United States
facility: 1241.30.10011 Boehringer Ingelheim Investigational Site
state: Texas
city: Norfolk
country: United States
facility: 1241.30.10002 Boehringer Ingelheim Investigational Site
state: Virginia
city: Berlin
country: Germany
facility: 1241.30.49002 Boehringer Ingelheim Investigational Site
city: Berlin
country: Germany
facility: 1241.30.49004 Boehringer Ingelheim Investigational Site
city: Berlin
country: Germany
facility: 1241.30.49005 Boehringer Ingelheim Investigational Site
city: Bonn
country: Germany
facility: 1241.30.49008 Boehringer Ingelheim Investigational Site
city: Frankfurt am Main
country: Germany
facility: 1241.30.49006 Boehringer Ingelheim Investigational Site
city: Hannover
country: Germany
facility: 1241.30.49001 Boehringer Ingelheim Investigational Site
city: Leipzig
country: Germany
facility: 1241.30.49003 Boehringer Ingelheim Investigational Site
city: Mainz
country: Germany
facility: 1241.30.49007 Boehringer Ingelheim Investigational Site
city: Barcelona
country: Spain
facility: 1241.30.34002 Boehringer Ingelheim Investigational Site
city: Barcelona
country: Spain
facility: 1241.30.34005 Boehringer Ingelheim Investigational Site
city: Madrid
country: Spain
facility: 1241.30.34003 Boehringer Ingelheim Investigational Site
city: Majadahonda (Madrid)
country: Spain
facility: 1241.30.34001 Boehringer Ingelheim Investigational Site
city: London
country: United Kingdom
facility: 1241.30.44002 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
citation: Sarrazin C, Manns M, Calleja JL, Garcia-Samaniego J, Forns X, Kaste R, Bai X, Wu J, Stern JO. HCVerso3: An Open-Label, Phase IIb Study of Faldaprevir and Deleobuvir with Ribavirin in Hepatitis C Virus Genotype-1b-Infected Patients with Cirrhosis and Moderate Hepatic Impairment. PLoS One. 2016 Dec 28;11(12):e0168544. doi: 10.1371/journal.pone.0168544. eCollection 2016.