Phase 3 Study of BI 207127 in Combination With Faldaprevir and Ribavirin for Treatment of Patients With Hepatitis C Infection, Including Patients Who Are Not Eligible to Receive Peginterferon: HCVerso2

Boehringer Ingelheim

Status and phase: Completed; Phase 3

Conditions: Hepatitis C, Chronic

Treatments: Drug: BI 207127-placebo: 8-week treatment; Drug: BI 207127: 24-week treatment; Drug: Faldaprevir: 24-week treatment; Drug: RBV: 24-week treatment; Drug: Ribavirin-placebo: 8-week treatment; Drug: Ribavirin: 16-week treatment; Drug: Ribavirin: 24-week treatment; Drug: BI 207127: 16-week treatment; Drug: Faldaprevir-placebo: 8-week treatment; Drug: Faldaprevir: 16-week treatment

Study type: Interventional

Funder types: Industry

Identifiers

NCT01728324

1241.36

2012-003535-27 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 496 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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496 participants in 3 patient groups

Randomised 24-week arm

Experimental group

Description:

BI 207127 in combination with FDV and RBV for 24 weeks (randomised)

Treatment:

Drug: Faldaprevir: 24-week treatment

Drug: RBV: 24-week treatment

Drug: BI 207127: 24-week treatment

Drug: Faldaprevir: 24-week treatment

Drug: BI 207127: 24-week treatment

Randomised 16-week arm

Experimental group

Description:

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)

Treatment:

Drug: BI 207127: 16-week treatment

Drug: Faldaprevir: 16-week treatment

Drug: Faldaprevir-placebo: 8-week treatment

Drug: BI 207127-placebo: 8-week treatment

Drug: Ribavirin-placebo: 8-week treatment

Drug: Ribavirin: 16-week treatment

Allocated 24-week arm

Experimental group

Description:

BI 207127 in combination with FDV and RBV for 24 weeks (allocated to patients with compensated cirrhosis)

Treatment:

Drug: Ribavirin: 24-week treatment

Drug: Faldaprevir: 24-week treatment

Drug: BI 207127: 24-week treatment

Drug: Faldaprevir: 24-week treatment

Drug: BI 207127: 24-week treatment