Phase 3 Efficacy and Safety Study of Peginterferon Lambda-1a and Ribavirin With Telaprevir
- Conditions
- Hepatitis C Virus
- Interventions
- Registration Number
- NCT01598090
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 881
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Part A: Peginterferon Lambda-1a + RBV + TVR Ribavirin - Part A: Peginterferon Lambda-1a + RBV + TVR Peginterferon Lambda-1a - Part B (Arm 2): Peginterferon Lambda-2a + RBV + TVR Peginterferon Alfa-2a - Part A: Peginterferon Lambda-1a + RBV + TVR Telaprevir - Part B (Arm 1): Peginterferon Lambda-1a + RBV + TVR Peginterferon Lambda-1a - Part B (Arm 1): Peginterferon Lambda-1a + RBV + TVR Ribavirin - Part B (Arm 1): Peginterferon Lambda-1a + RBV + TVR Telaprevir - Part B (Arm 2): Peginterferon Lambda-2a + RBV + TVR Ribavirin - Part B (Arm 2): Peginterferon Lambda-2a + RBV + TVR Telaprevir -
- Primary Outcome Measures
Name Time Method Percentage of Participants With Extended Rapid Virologic Response (eRVR) - Part A Assessed at Week 4 and Week 12, week 12 reported eRVR was defined as Hepatitis C virus (HCV) RNA level below the lower limit of quantitation, target not detected at Weeks 4 and 12 of treatment. HCV RNA level was measured using the Roche COBAS® TaqMan HCV Test v.2.0 (lower limit of quantitation =25 IU/mL; limit of detection \~ 10 IU/mL).
Percentage of Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) - Part B Follow-up Week 12 SVR12 was defined as Hepatitis C virus (HCV) RNA level below lower limit of quantitation, target detected or not detected at Week 12 of post-treatment follow-up. HCV RNA level was measured using the Roche COBAS® TaqMan HCV Test v.2.0 (lower limit of quantitation =25 IU/mL; limit of detection \~ 10 IU/mL).
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Drug Related AEs, Discontinuation Due to AEs, Dose Reductions and Death - Part A Day 1 of treatment up to Week 48 An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a participant or clinical investigation participant administered an investigational (medicinal product. An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization or caused prolongation of existing hospitalization.
- Secondary Outcome Measures
Name Time Method Percentage of Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) - Part A Follow-up Week 12 SVR12 was defined as Hepatitis C virus (HCV) RNA level below lower limit of quantitation (LLOQ), target detected or not detected at Week 12 of post-treatment follow-up. HCV RNA level was measured using the Roche COBAS® TaqMan HCV Test v.2.0 (LLOQ =25 IU/mL; limit of detection \~ 10 IU/mL).
Percentage of Participants With Treatment Emergent Cytopenic Abnormalities - Part B After Day 1 of treatment up to Week 48 Cytopenic abnormalities included anemia defined as hemoglobin \<10 grams/decilitre; neutropenia defined as Absolute neutrophil count (ANC) \<750 cubic millimetre (mm\^3); thrombocytopenia defined as platelets \<50,000 mm\^3.
Percentage of Subjects With Sustained Virologic Response at Follow-Up Week 24 (SVR24) - Part A Follow up week 24 SVR24 was defined as Hepatitis C virus (HCV) RNA level below lower limit of quantitation (LLOQ), target detected or not detected at Week 24 of post-treatment follow-up. HCV RNA level was measured using the Roche COBAS® TaqMan HCV Test v.2.0 (LLOQ) =25 IU/mL; limit of detection \~ 10 IU/mL). The analysis was performed using Modified Intent-to-Treat method defined as the proportions of participants meeting the response criteria in numerator and denominator based on all treated participants. The analysis was performed in all treated participants.
Percentage of Treatment-Naïve Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) - Part B Follow-up Week 12 SVR12 was defined as Hepatitis C virus (HCV) RNA level below lower limit of quantitation, target detected or not detected at Week 12 of post-treatment follow-up. HCV RNA level was measured using the Roche COBAS® TaqMan HCV Test v.2.0 (lower limit of quantitation =25 IU/mL; limit of detection \~ 10 IU/mL).
Percentage of Participants With Extended Rapid Virologic Response (eRVR) - Part B Week 4 and Week 12 eRVR was defined as Hepatitis C virus (HCV) RNA level below the lower limit of quantitation, target not detected at Weeks 4 and 12 of treatment. HCV RNA level was measured using the Roche COBAS® TaqMan HCV Test v.2.0 (lower limit of quantitation =25 IU/mL; limit of detection \~ 10 IU/mL).
Percentage of Participants With On-Treatment Flu-Like Symptoms And Musculoskeletal Symptoms- Part B After Day 1 of treatment up to Week 48 Flu-like symptoms included pyrexia, chills, and pain. Musculoskeletal symptoms included arthralgia, myalgia, and back pain.
Percentage of Participants With Sustained Virologic Response at Follow- upWeek 24 (SVR24) - Part B Follow-up Week 24 SVR24 was defined as Hepatitis C virus (HCV) RNA level below lower limit of quantitation (LLOQ), target detected or not detected at Week 24 of post-treatment follow-up. HCV RNA level was measured using the Roche COBAS® TaqMan HCV Test v.2.0 (LLOQ) =25 IU/mL; limit of detection \~ 10 IU/mL).
Percentage of Participants With Rash After Day 1 of treatment up to Week 48 All skin reactions involving rash or rash-like events that occurred on treatment were reported.
Trial Locations
- Locations (35)
Birmingham Gastroenterology Associates, P.C.
🇺🇸Birmingham, Alabama, United States
The Kirklin Clinic
🇺🇸Birmingham, Alabama, United States
The University Of Alabama Of Birmingham
🇺🇸Birmingham, Alabama, United States
Anaheim Clinical Trials Llc
🇺🇸Anaheim, California, United States
Sc Clinical Research, Inc.
🇺🇸Garden Grove, California, United States
Va Long Beach Healthcare System
🇺🇸Long Beach, California, United States
Cedars Sinai Medical Center
🇺🇸Los Angeles, California, United States
Va Greater Los Angeles Healthcare System
🇺🇸Los Angeles, California, United States
University Of California, San Francisco/Sf General Hospital
🇺🇸San Francisco, California, United States
South Bay Ge Medical Group
🇺🇸Torrance, California, United States
Scroll for more (25 remaining)Birmingham Gastroenterology Associates, P.C.🇺🇸Birmingham, Alabama, United States