Phase 3 Efficacy and Safety Study of Peginterferon Lambda-1a and Ribavirin With Telaprevir (PEDESTAL)

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 3

Conditions: Hepatitis C Virus

Treatments: Biological: Peginterferon Lambda-1a; Biological: Peginterferon Alfa-2a; Drug: Ribavirin; Drug: Telaprevir

Study type: Interventional

Funder types: Industry

Identifiers

NCT01598090

2011-004695-11 (EudraCT Number)

AI452-020

Details and patient eligibility

About

The purpose of this study is to determine whether Peginterferon Lambda-1a (Lambda) combined with Ribavirin (RBV) and Telaprevir (TVR) is effective in the treatment of chronic Hepatitis C (CHC) compared to Peginterferon Alfa-2a (alfa-2a) combined with RBV and Telaprevir.

Enrollment: 881 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.

Inclusion Criteria:

• Chronic hepatitis C genotype 1. GT-1b Capped at 50 % of naïve subjects
• Naives to prior anti-HCV therapy [Interferon (IFN) and direct antiviral agent (DAA) based]
• Relapsers (defined as subjects who had undetectable HCV ribonucleic acid (RNA) on prior treatment regimen of alfa-2a/RBV and Hepatitis C Virus (HCV) RNA > 25IU/mL after discontinuation of treatment). Capped at 20%
• HCV RNA ≥ 100,000 IU/mL
• Subjects with compensated cirrhosis can be enrolled and will be capped at approximately 10%
• Seronegative for human immunodeficiency virus (HIV) and hepatitis B surface antigen (HBsAg)
• Men or women, 18-70 years of age

Exclusion Criteria:

• Chronic liver disease due to causes other than chronic HCV
• Current or past evidence of decompensation
• Conditions that preclude the use of Alfa/RBV/TVR per respective labels
• Diagnosed or suspected hepatocellular carcinoma

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

881 participants in 3 patient groups

Part A: Peginterferon Lambda-1a + RBV + TVR

Experimental group

Treatment:

Drug: Telaprevir

Drug: Ribavirin

Biological: Peginterferon Lambda-1a

Part B (Arm 1): Peginterferon Lambda-1a + RBV + TVR

Experimental group

Treatment:

Drug: Telaprevir

Drug: Ribavirin

Biological: Peginterferon Lambda-1a

Part B (Arm 2): Peginterferon Lambda-2a + RBV + TVR

Experimental group

Treatment:

Drug: Telaprevir

Drug: Ribavirin

Biological: Peginterferon Alfa-2a