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

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 Overview

• Status: Completed
• Conditions: Hepatitis C Virus
• Intervention / Treatment: Biological: Peginterferon Lambda-1a; Drug: Ribavirin; Drug: Telaprevir; Biological: Peginterferon Alfa-2a

• Study Type: Interventional
• Enrollment (Actual): 881
• Phase: Phase 3

Contacts and Locations

Study Locations

• Austria
  • Graz, Austria, 8036
    • Local Institution
  • Linz, Austria, 4010
    • Local Institution
• Belgium
  • Bruxelles, Belgium, 1200
    • Local Institution
  • Edegem, Belgium, 2650
    • Local Institution
  • Leuven, Belgium, 3000
    • Local Institution
  • Liege, Belgium, 4000
    • Local Institution
• Brazil
  • Rio De Janeiro, Brazil, 21040-000
    • Local Institution
  • Rio De Janeiro, Brazil, 21040
    • Local Institution
  • Sao Paulo, Brazil, 04035-970
    • Local Institution
  • Sao Paulo, Brazil, 04035
    • Local Institution
  • Bahia
    • Salvador, Bahia, Brazil, 40110
      • Local Institution
    • Salvador, Bahia, Brazil, 40110-160
      • Local Institution
  • Parana
    • Curitiba, Parana, Brazil, 80240-280
      • Local Institution
    • Curitiba, Parana, Brazil, 80240
      • Local Institution
  • RIO Grande DO SUL
    • Porto Alegre, RIO Grande DO SUL, Brazil, 90035-003
      • Local Institution
  • Rio Grande Do Sul
    • Porto Alegre, Rio Grande Do Sul, Brazil, 90035
      • Local Institution
  • SAO Paulo
    • Botucatu, SAO Paulo, Brazil, 18618-000
      • Local Institution
  • Sao Paulo
    • Botucatu, Sao Paulo, Brazil, 18618
      • Local Institution
• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 4Z6
      • University of Calgary
  • British Columbia
    • Vancouver, British Columbia, Canada, V6Z 2K5
      • Gastrointestinal Research Institute (G.I.R.I.)
    • Vancouver, British Columbia, Canada, V5Z 1H2
      • Liver And Intestinal Research Centre (Lair)
    • Victoria, British Columbia, Canada, V8V 3P9
      • Percuro Clinical Research Ltd
  • Ontario
    • Toronto, Ontario, Canada, M5G 2N2
      • Toronto General Hospital
  • Quebec
    • Montreal, Quebec, Canada, H1T 2M4
      • Hôpital Maisonneuve-Rosemont
• Czechia
  • Hradec Kralove, Czechia, 500 05
    • Local Institution
  • Praha 2, Czechia, 120 00
    • Local Institution
  • Praha 4, Czechia, 140 21
    • Local Institution
• France
  • Orleans Cedex 2, France, 45067
    • Local Institution
  • Poitiers, France, 86021
    • Local Institution
  • Rennes Cedex 9, France, 35033
    • Local Institution
  • Rouen Cedex, France, 76031
    • Local Institution
  • Toulouse Cedex, France, 31059
    • Local Institution
  • Villejuif, France, 94804
    • Local Institution
• Germany
  • Berlin, Germany, 10969
    • Local Institution
  • Essen, Germany, 45122
    • Local Institution
  • Frankfurt, Germany, 60590
    • Local Institution
  • Hamburg, Germany, 20246
    • Local Institution
  • Hannover, Germany, 30625
    • Local Institution
  • Muenster, Germany, 48149
    • Local Institution
  • Ulm, Germany, 89081
    • Local Institution
• Israel
  • Haifa, Israel, 31096
    • Local Institution
  • Haifa, Israel, 34362
    • Local Institution
  • Jerusalem, Israel, 91031
    • Local Institution
  • Nazareth, Israel, 16100
    • Local Institution
  • Ramat Gan, Israel, 52621
    • Local Institution
• Italy
  • Bergamo, Italy, 24127
    • Local Institution
  • Cisanello (pisa), Italy, 56124
    • Local Institution
  • Milano, Italy, 20121
    • Local Institution
  • Roma, Italy, 00149
    • Local Institution
  • Torino, Italy, 10126
    • Local Institution
• Poland
  • Bialystok, Poland, 15-540
    • Local Institution
  • Kielce, Poland, 25-726
    • Local Institution
  • Lancut, Poland, 37-100
    • Local Institution
  • Myslowice, Poland, 41-400
    • Local Institution
  • Raciborz, Poland, 47-400
    • Local Institution
  • Wroclaw, Poland, 50-220
    • Local Institution
• Russian Federation
  • Moscow, Russian Federation, 111123
    • Local Institution
  • Moscow, Russian Federation, 117198
    • Local Institution
  • Moscow, Russian Federation, 105275
    • Local Institution
  • Moscow, Russian Federation, 115446
    • Local Institution
  • Moscow, Russian Federation, 117593
    • Local Institution
  • Moscow, Russian Federation, 127015
    • Local Institution
  • Moscow, Russian Federation, 107996
    • Local Institution
  • Saint Petersburg, Russian Federation, 194100
    • Local Institution
  • St-petersburg, Russian Federation, 198103
    • Local Institution
  • Stavropol, Russian Federation, 355017
    • Local Institution
  • Republic OF Tatarstan
    • Kazan, Republic OF Tatarstan, Russian Federation, 420012
      • Local Institution
• Spain
  • A Coruna, Spain, 15006
    • Local Institution
  • Alicante, Spain, 03010
    • Local Institution
  • San Sebastian, Spain, 20014
    • Local Institution
  • Santiago De Compostela, Spain, 15706
    • Local Institution
  • Sevilla, Spain, 41014
    • Local Institution
  • Sevilla, Spain, 41013
    • Local Institution
• Switzerland
  • Basel, Switzerland, 4031
    • Local Institution
  • Zurich, Switzerland, 8091
    • Local Institution
• United Kingdom
  • WEST Midlands
    • Birmingham, WEST Midlands, United Kingdom, B15 2TH
      • Local Institution
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • The Kirklin Clinic
    • Birmingham, Alabama, United States, 35209
      • Birmingham Gastroenterology Associates, P.C.
    • Birmingham, Alabama, United States, 35294
      • The University Of Alabama Of Birmingham
  • California
    • Anaheim, California, United States, 92801
      • Anaheim Clinical Trials Llc
    • Garden Grove, California, United States, 92844
      • SC Clinical Research, Inc.
    • Long Beach, California, United States, 90822
      • VA Long Beach Healthcare System
    • Los Angeles, California, United States, 90048
      • Cedars Sinai Medical Center
    • Los Angeles, California, United States, 90073
      • VA Greater Los Angeles Healthcare System
    • San Francisco, California, United States, 94110
      • University Of California, San Francisco/Sf General Hospital
    • Torrance, California, United States, 90505
      • South Bay Ge Medical Group
  • Florida
    • Orlando, Florida, United States, 32809
      • Orlando Clinical Research Center
    • Orlando, Florida, United States, 32803
      • Orlando VA Medical Center
    • Tampa, Florida, United States, 33614
      • Infectious Disease Research Institute, Inc.
  • Georgia
    • Marietta, Georgia, United States, 30060
      • Gastrointestinal Specialists of Georgia PC
  • Maryland
    • Baltimore, Maryland, United States, 21202
      • Mercy Medical Center
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • Saint Luke'S Transplant Specialists
    • Saint Louis, Missouri, United States, 63104
      • Saint Louis University
  • North Carolina
    • Charlotte, North Carolina, United States, 28204
      • Carolinas Medical Center
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74104
      • Options Health Research, LLC
    • Tulsa, Oklahoma, United States, 74135
      • Healthcare Research Consultants
  • Tennessee
    • Germantown, Tennessee, United States, 38138
      • Gastro One
  • Texas
    • Arlington, Texas, United States, 76012
      • Texas Clinical Research Institute
    • Fort Sam Houston, Texas, United States, 78234
      • Brooke Army Medical Center
    • San Antonio, Texas, United States, 78215
      • Alamo Medical Research
  • Utah
    • Murray, Utah, United States, 84123
      • Clinical Research Centers Of America
  • Virginia
    • Annandale, Virginia, United States, 22003
      • Metropolitan Research
    • Newport News, Virginia, United States, 23602
      • Bon Secours St. Mary's Hospital of Richmond, Inc.
    • Norfolk, Virginia, United States, 23502
      • Digestive and Liver Disease Specialists

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part A: Peginterferon Lambda-1a + RBV + TVR	Biological: Peginterferon Lambda-1a; Syringes, subcutaneous (SC), 180μg, Once weekly, 24 or 48 weeks depending on response; Drug: Ribavirin; Tablets, Oral, 1000 or 1200 mg based on weight, twice daily, 24 or 48 weeks depending on response; Drug: Telaprevir; Tablets, Oral, 750 mg, three times a day, 12 weeks only; Other Names: Incivek
Experimental: Part B (Arm 1): Peginterferon Lambda-1a + RBV + TVR	Biological: Peginterferon Lambda-1a; Syringes, subcutaneous (SC), 180μg, Once weekly, 24 or 48 weeks depending on response; Drug: Ribavirin; Tablets, Oral, 1000 or 1200 mg based on weight, twice daily, 24 or 48 weeks depending on response; Drug: Telaprevir; Tablets, Oral, 750 mg, three times a day, 12 weeks only; Other Names: Incivek
Experimental: Part B (Arm 2): Peginterferon Lambda-2a + RBV + TVR	Drug: Ribavirin; Tablets, Oral, 1000 or 1200 mg based on weight, twice daily, 24 or 48 weeks depending on response; Drug: Telaprevir; Tablets, Oral, 750 mg, three times a day, 12 weeks only; Other Names: Incivek; Biological: Peginterferon Alfa-2a; Syringes, SC, 180μg, Once weekly, 24 or 48 weeks depending on response; Other Names: Pegasys

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Follow-up Week 12
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.	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).	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.	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).	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.	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).	Follow-up Week 24
Percentage of Participants With Rash	All skin reactions involving rash or rash-like events that occurred on treatment were reported.	After Day 1 of treatment up to Week 48

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb

Publications and helpful links

General Publications

• 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.

Helpful Links

• BMS clinical trial educational resource
• BMS Clinical Trial Patient Recruiting

Study record dates

Study Major Dates

• Study Start (Actual): June 14, 2012
• Primary Completion (Actual): February 4, 2015
• Study Completion (Actual): May 15, 2015

Study Registration Dates

• First Submitted: May 9, 2012
• First Submitted That Met QC Criteria: May 11, 2012
• First Posted (Estimate): May 15, 2012

Study Record Updates

• Last Update Posted (Actual): July 31, 2019
• Last Update Submitted That Met QC Criteria: July 29, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Flaviviridae Infections; Hepatitis, Viral, Human; Hepatitis; Hepatitis C; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Antimetabolites; Ribavirin; Peginterferon alfa-2a
• Other Study ID Numbers: AI452-020; 2011-004695-11 (EudraCT Number)