Overview

This trial is active, not recruiting.

Condition hepatitis c, chronic
Treatments bi 207127-placebo: 8-week treatment, ribavirin: 24-week treatment, bi 207127: 24-week treatment, faldaprevir: 24-week treatment, ribavirin-placebo: 8-week treatment, faldaprevir-placebo: 8-week treatment, faldaprevir: 16-week treatment, ribavirin: 16-week treatment, rbv: 24-week treatment, bi 207127: 16-week treatment
Phase phase 3
Sponsor Boehringer Ingelheim
Start date November 2012
End date February 2014
Trial size 498 participants
Trial identifier NCT01728324, 1241.36, 2012-003535-27

Summary

The aim of the study is to confirm efficacy and safety of treatment with 600 mg of BID BI 207127 in combination with 120 mg QD FDV and RBV for 16 or 24 weeks in target chronically infected HCV GT1b treatment naïve patients, including patients with compensated cirrhosis.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double-blind
Primary purpose treatment
Arm
(Experimental)
BI 207127 in combination with FDV and RBV for 24 weeks (randomised)
bi 207127: 24-week treatment
24 weeks of active treatment
faldaprevir: 24-week treatment
24 weeks of active treatment
rbv: 24-week treatment
24 weeks of active treatment
(Experimental)
BI 207127-placebo, FDV-placebo and RBV-placebo for 8 weeks followed by BI 207127 in combination with FDV and RBV for 16 weeks (randomised)
bi 207127-placebo: 8-week treatment
8 weeks of placebo treatment
ribavirin-placebo: 8-week treatment
8 weeks of placebo treatment
faldaprevir-placebo: 8-week treatment
8 weeks of placebo treatment
faldaprevir: 16-week treatment
16 weeks of active treatment
ribavirin: 16-week treatment
16 weeks of active treatment
bi 207127: 16-week treatment
16 weeks of active treatment
(Experimental)
BI 207127 in combination with FDV and RBV for 24 weeks (allocated to patients with compensated cirrhosis)
ribavirin: 24-week treatment
24 weeks of active treatment
faldaprevir: 24-week treatment
24 weeks of active treatment
bi 207127: 24-week treatment
24 weeks of active treatment

Primary Outcomes

Measure
Sustained Virologic Response (SVR) at Week 12 post-treatment (SVR12)
time frame: at Week 12 post-treatment

Secondary Outcomes

Measure
SVR4
time frame: at Week 4 post-treatment
SVR24
time frame: at Week 24 post-treatment

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

Inclusion criteria: 1. Chronic hepatitis C infection, diagnosed by positive anti-HCV antibodies and detected HCV RNA at screening 2. HCV infection of sub-GT1b confirmed by genotypic testing at screening. 3. HCV viral load =1,000 IU/mL at randomisation. 4. Patients who have never been previously treated with any other HCV treatment regimen. Exclusion criteria: 1. HCV infection of mixed GT (1/2, 1/3, and 1/4) diagnosed by genotypic testing at screening. 2. HCV infection of sub-GT1a, mixed GT1a/1b, or undefined GT1. 3. Liver disease due to causes other than chronic HCV infection. 4. HIV infection. 5. Hepatitis B virus infection based on presence of HBs-Ag. 6. Confirmed or suspected active malignancy or history of malignancy within the last 5 years prior to screening. 7. History of illicit drug abuse other than cannabis or chronic alcohol abuse within 12 months prior to randomisation. 8. Subject is not willing to comply with the precautionary measures to prevent photosensitivity (avoid excessive sun exposure and use sun block on a daily basis). 9. Decompensated liver disease, or history of decompensated liver disease. 10. Clinical evidence of unstable cardiovascular disease which may further decompensate due to anemia. 11. Red blood cell disorders. 12. Body weight <40 kg or >125 kg.

Additional Information

Official title A Phase III Randomised, Partially Double-blind and Placebo-controlled Study of BI 207127 in Combination With Faldaprevir and Ribavirin for Chronic Genotype 1 Hepatitis C Infection in an Extended Population of Treatment naïve Patients That Includes Those Ineligible to Receive Peginterferon
Trial information was received from ClinicalTrials.gov and was last updated in August 2014.
Information provided to ClinicalTrials.gov by Boehringer Ingelheim.