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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
881
Syringes, subcutaneous (SC), 180μg, Once weekly, 24 or 48 weeks depending on response
Syringes, SC, 180μg, Once weekly, 24 or 48 weeks depending on response
Tablets, Oral, 1000 or 1200 mg based on weight, twice daily, 24 or 48 weeks depending on response
Percentage of Participants With Extended Rapid Virologic Response (eRVR) - Part A
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).
Time frame: Assessed at Week 4 and Week 12, week 12 reported
Percentage of Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) - Part B
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).
Time frame: Follow-up Week 12
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Drug Related AEs, Discontinuation Due to AEs, Dose Reductions and Death - Part A
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.
Time frame: Day 1 of treatment up to Week 48
Percentage of Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) - Part A
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).
Time frame: Follow-up Week 12
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Tablets, Oral, 750 mg, three times a day, 12 weeks only
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
...and 94 more locations
Percentage of Subjects With Sustained Virologic Response at Follow-Up Week 24 (SVR24) - Part A
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.
Time frame: Follow up week 24
Percentage of Treatment-Naïve Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) - Part B
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).
Time frame: Follow-up Week 12
Percentage of Participants With Treatment Emergent Cytopenic Abnormalities - Part B
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.
Time frame: After Day 1 of treatment up to Week 48
Percentage of Participants With Extended Rapid Virologic Response (eRVR) - Part B
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).
Time frame: Week 4 and Week 12
Percentage of Participants With On-Treatment Flu-Like Symptoms And Musculoskeletal Symptoms- Part B
Flu-like symptoms included pyrexia, chills, and pain. Musculoskeletal symptoms included arthralgia, myalgia, and back pain.
Time frame: After Day 1 of treatment up to Week 48
Percentage of Participants With Sustained Virologic Response at Follow- upWeek 24 (SVR24) - Part B
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).
Time frame: Follow-up Week 24
Percentage of Participants With Rash
All skin reactions involving rash or rash-like events that occurred on treatment were reported.
Time frame: After Day 1 of treatment up to Week 48