Phase 3 Efficacy and Safety Study of Peginterferon Lambda-1a and Ribavirin With Telaprevir
PEDESTAL
A Phase 3 Blinded Randomized Study of Peginterferon Lambda-1a and Ribavirin Compared to Peginterferon Alfa-2a and Ribavirin, Each Administered With Telaprevir in Subjects With Genotype-1 Chronic Hepatitis C Who Are Treatment-naive or Relapsed on Prior Treatment With Peginterferon Alfa-2a and Ribavirin
2 other identifiers
interventional
881
15 countries
104
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jun 2012
Typical duration for phase_3
104 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 9, 2012
CompletedFirst Posted
Study publicly available on registry
May 15, 2012
CompletedStudy Start
First participant enrolled
June 14, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 4, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
May 15, 2015
CompletedResults Posted
Study results publicly available
May 21, 2019
CompletedJuly 31, 2019
July 1, 2019
2.6 years
May 9, 2012
March 21, 2019
July 29, 2019
Conditions
Outcome Measures
Primary Outcomes (3)
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).
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).
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.
Day 1 of treatment up to Week 48
Secondary Outcomes (8)
Percentage of Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) - Part A
Follow-up Week 12
Percentage of Subjects With Sustained Virologic Response at Follow-Up Week 24 (SVR24) - Part A
Follow up week 24
Percentage of Treatment-Naïve Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) - Part B
Follow-up Week 12
Percentage of Participants With Treatment Emergent Cytopenic Abnormalities - Part B
After Day 1 of treatment up to Week 48
Percentage of Participants With Extended Rapid Virologic Response (eRVR) - Part B
Week 4 and Week 12
- +3 more secondary outcomes
Study Arms (3)
Part A: Peginterferon Lambda-1a + RBV + TVR
EXPERIMENTALPart B (Arm 1): Peginterferon Lambda-1a + RBV + TVR
EXPERIMENTALPart B (Arm 2): Peginterferon Lambda-2a + RBV + TVR
EXPERIMENTALInterventions
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
Tablets, Oral, 750 mg, three times a day, 12 weeks only
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (104)
Birmingham Gastroenterology Associates, P.C.
Birmingham, Alabama, 35209, United States
The Kirklin Clinic
Birmingham, Alabama, 35294, United States
The University Of Alabama Of Birmingham
Birmingham, Alabama, 35294, United States
Anaheim Clinical Trials Llc
Anaheim, California, 92801, United States
Sc Clinical Research, Inc.
Garden Grove, California, 92844, United States
Va Long Beach Healthcare System
Long Beach, California, 90822, United States
Cedars Sinai Medical Center
Los Angeles, California, 90048, United States
Va Greater Los Angeles Healthcare System
Los Angeles, California, 90073, United States
University Of California, San Francisco/Sf General Hospital
San Francisco, California, 94110, United States
South Bay Ge Medical Group
Torrance, California, 90505, United States
Orlando Va Medical Center
Orlando, Florida, 32803, United States
Orlando Clinical Research Center
Orlando, Florida, 32809, United States
Infectious Disease Research Institute, Inc.
Tampa, Florida, 33614, United States
Gastrointestinal Specialists Of Georgia Pc
Marietta, Georgia, 30060, United States
Mercy Medical Center
Baltimore, Maryland, 21202, United States
Saint Luke'S Transplant Specialists
Kansas City, Missouri, 64111, United States
Saint Louis University
St Louis, Missouri, 63104, United States
Carolinas Medical Center
Charlotte, North Carolina, 28204, United States
Options Health Research, Llc
Tulsa, Oklahoma, 74104, United States
Healthcare Research Consultants
Tulsa, Oklahoma, 74135, United States
Gastro One
Germantown, Tennessee, 38138, United States
Texas Clinical Research Institute
Arlington, Texas, 76012, United States
Brooke Army Medical Center
Fort Sam Houston, Texas, 78234, United States
Alamo Medical Research
San Antonio, Texas, 78215, United States
Clinical Research Centers Of America
Murray, Utah, 84123, United States
Metropolitan Research
Annandale, Virginia, 22003, United States
Bon Secours St. Mary'S Hospital Of Richmond, Inc.
Newport News, Virginia, 23602, United States
Digestive And Liver Disease Specialists
Norfolk, Virginia, 23502, United States
Local Institution
Graz, 8036, Austria
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Linz, 4010, Austria
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Brussels, 1200, Belgium
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Edegem, 2650, Belgium
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Leuven, 3000, Belgium
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Liège, 4000, Belgium
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Salvador, Estado de Bahia, 40110-160, Brazil
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Salvador, Estado de Bahia, 40110, Brazil
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Curitiba, Paraná, 80240-280, Brazil
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Curitiba, Paraná, 80240, Brazil
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Porto Alegre, Rio Grande do Sul, 90035-003, Brazil
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Porto Alegre, Rio Grande do Sul, 90035, Brazil
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Botucatu, São Paulo, 18618-000, Brazil
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Botucatu, São Paulo, 18618, Brazil
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Rio de Janeiro, 21040-000, Brazil
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Rio de Janeiro, 21040, Brazil
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São Paulo, 04035-970, Brazil
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São Paulo, 04035, Brazil
University Of Calgary
Calgary, Alberta, T2N 4Z6, Canada
Liver And Intestinal Research Centre (Lair)
Vancouver, British Columbia, V5Z 1H2, Canada
Gastrointestinal Research Institute (G.I.R.I.)
Vancouver, British Columbia, V6Z 2K5, Canada
Percuro Clinical Research Ltd
Victoria, British Columbia, V8V 3P9, Canada
Toronto General Hospital
Toronto, Ontario, M5G 2N2, Canada
Hopital Maisonneuve-Rosemont
Montreal, Quebec, H1T 2M4, Canada
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Hradec Králové, 500 05, Czechia
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Prague, 120 00, Czechia
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Prague, 140 21, Czechia
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Orléans, 45067, France
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Poitiers, 86021, France
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Rennes, 35033, France
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Rouen, 76031, France
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Toulouse, 31059, France
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Villejuif, 94804, France
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Berlin, 10969, Germany
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Essen, 45122, Germany
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Frankfurt, 60590, Germany
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Hamburg, 20246, Germany
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Hanover, 30625, Germany
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Münster, 48149, Germany
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Ulm, 89081, Germany
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Haifa, 31096, Israel
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Haifa, 34362, Israel
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Jerusalem, 91031, Israel
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Nazareth, 16100, Israel
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Ramat Gan, 52621, Israel
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Bergamo, 24127, Italy
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Cisanello (pisa), 56124, Italy
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Milan, 20121, Italy
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Roma, 00149, Italy
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Torino, 10126, Italy
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Bialystok, 15-540, Poland
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Kielce, 25-726, Poland
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Mysłowice, 41-400, Poland
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Racibórz, 47-400, Poland
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Wroclaw, 50-220, Poland
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Łańcut, 37-100, Poland
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Kazan', Tatarstan Republic, 420012, Russia
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Moscow, 105275, Russia
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Moscow, 107996, Russia
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Moscow, 111123, Russia
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Moscow, 115446, Russia
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Moscow, 117198, Russia
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Moscow, 117593, Russia
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Moscow, 127015, Russia
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Saint Petersburg, 194100, Russia
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Saint Petersburg, 198103, Russia
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Stavropol, 355017, Russia
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A Coruña, 15006, Spain
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Alicante, 03010, Spain
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Donostia / San Sebastian, 20014, Spain
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Santiago de Compostela, 15706, Spain
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Seville, 41013, Spain
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Seville, 41014, Spain
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Basel, 4031, Switzerland
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Zurich, 8091, Switzerland
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Birmingham, WEST Midlands, B15 2TH, United Kingdom
Related Publications (1)
Heim MH. 25 years of interferon-based treatment of chronic hepatitis C: an epoch coming to an end. Nat Rev Immunol. 2013 Jul;13(7):535-42. doi: 10.1038/nri3463. Epub 2013 Jun 7.
PMID: 23743475DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Bristol-Myers Squibb Study Director
- Organization
- Bristol-Myers Squibb
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 9, 2012
First Posted
May 15, 2012
Study Start
June 14, 2012
Primary Completion
February 4, 2015
Study Completion
May 15, 2015
Last Updated
July 31, 2019
Results First Posted
May 21, 2019
Record last verified: 2019-07