Safety and Efficacy Study of Pegylated Interferon Lambda With and Without Daclatasvir, Compared to Pegylated Interferon Alfa, Plus Ribavirin in Subjects With Hepatitis C Genotype 2 and 3 (PRINCIPAL)

September 23, 2015 updated by: Bristol-Myers Squibb

A Phase 3, Randomized, Double-Blind, Controlled Study Evaluating the Efficacy and Safety of Peginterferon Lambda-1a, With and Without Daclatasvir, Compared to Peginterferon Alfa-2a, Each in Combination With Ribavirin, in the Treatment of Naïve Genotype 2 and 3 Chronic Hepatitis C Subjects

The purpose of this study is to determine if 24 weeks of treatment with Pegylated Interferon Lambda plus Ribavirin and 12 weeks of treatment with Pegylated Interferon Lambda plus Ribavirin and Daclatasvir will be safe and effective for treatment of hepatitis C compared to 24 weeks of treatment with Pegylated Interferon Alfa-2a plus Ribavirin

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

880

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1280AEB
        • Local Institution
      • Cordoba, Argentina, 5000
        • Local Institution
    • Buenos Aires
      • Autonoma, Buenos Aires, Argentina, C1119ACN
        • Local Institution
      • Ciudad De Buenos Aires, Buenos Aires, Argentina, C1121ABE
        • Local Institution
      • Ciudad De Buenos Aires, Buenos Aires, Argentina, C1181ACH
        • Local Institution
      • Mar Del Plata, Buenos Aires, Argentina, 7600
        • Local Institution
      • Quilmes, Buenos Aires, Argentina, B1878DVB
        • Local Institution
    • Santa Fe
      • Prov De Santa Fe, Santa Fe, Argentina, 2000
        • Local Institution
  • Australia
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
        • Local Institution
      • Concord, New South Wales, Australia, 2139
        • Local Institution
      • Darlinghurst, New South Wales, Australia, 2010
        • Local Institution
      • Randwick, New South Wales, Australia, 2031
        • Local Institution
      • Westmead Nsw, New South Wales, Australia, 2145
        • Local Institution
    • Queensland
      • Brisbane, Queensland, Australia, 4102
        • Local Institution
      • Greenslopes, Queensland, Australia, 4120
        • Local Institution
      • Herston, Queensland, Australia, 4029
        • Local Institution
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Local Institution
    • Victoria
      • Clayton Vic, Victoria, Australia, 3168
        • Local Institution
      • Fitzroy, Victoria, Australia, 3065 VIC
        • Local Institution
      • Melbourne, Victoria, Australia, 3004
        • Local Institution
      • Parville, Victoria, Australia, 3050
        • Local Institution
    • Western Australia
      • Fremantle, Western Australia, Australia, 6160
        • Local Institution
  • Belgium
      • Brussels, Belgium, 1070
        • Local Institution
      • Leuven, Belgium, 3000
        • Local Institution
      • Liege, Belgium, 4000
        • Local Institution
  • Chile
    • Metropolitana
      • Santiago, Metropolitana, Chile
        • Local Institution
  • Finland
      • Hus, Finland, 00029
        • Local Institution
  • France
      • Clichy Cedex, France, 92118
        • Local Institution
      • Creteil Cedex, France, 94010
        • Local Institution
      • Montpellier Cedex 5, France, 34295
        • Local Institution
      • Nice Cedex 3, France, 06202
        • Local Institution
  • Greece
      • Athens, Greece, 115 23
        • Local Institution
      • Thessaloniki, Greece, 54006
        • Local Institution
  • Hong Kong
      • Hong Kong, Hong Kong
        • Local Institution
      • Tai Po, Hong Kong
        • Local Institution
  • Italy
      • Firenze, Italy, 50134
        • Local Institution
      • Milano, Italy, 20122
        • Local Institution
      • Milano, Italy, 20142
        • Local Institution
      • Napoli, Italy, 80131
        • Local Institution
      • Novara, Italy, 28100
        • Local Institution
  • Japan
      • Fukuoka, Japan, 8158555
        • Local Institution
      • Miyazaki, Japan, 8800003
        • Local Institution
      • Saga, Japan, 8408571
        • Local Institution
      • Saitama, Japan, 3380001
        • Local Institution
    • Fukuoka
      • Fukuoka-shi, Fukuoka, Japan, 8108563
        • Local Institution
      • Kitakyushu, Fukuoka, Japan, 8030816
        • Local Institution
    • Hiroshima
      • Hiroshima-Shi, Hiroshima, Japan, 7348551
        • Local Institution
    • Hokkaido
      • Sapporo-shi, Hokkaido, Japan, 0600033
        • Local Institution
    • Hyogo
      • Kobe-shi, Hyogo, Japan, 6500047
        • Local Institution
    • Ibaraki
      • Tsuchiura-shi, Ibaraki, Japan, 300-0053
        • Local Institution
    • Kagawa
      • Takamatsu-shi, Kagawa, Japan, 7608557
        • Local Institution
    • Kagoshima
      • Kagoshima-shi, Kagoshima, Japan, 8908520
        • Local Institution
    • Kanagawa
      • Kawasaki-shi, Kanagawa, Japan, 2138587
        • Local Institution
    • Okayama
      • Okayama-shi, Okayama, Japan, 7008558
        • Local Institution
    • Saitama
      • Iruma-gun, Saitama, Japan, 3500495
        • Local Institution
    • Tokyo
      • Bunkyo-ku, Tokyo, Japan, 1138655
        • Local Institution
      • Minato-ku, Tokyo, Japan, 1058470
        • Local Institution
      • Musashino-shi, Tokyo, Japan, 1808610
        • Local Institution
    • Wakayama
      • Wakayama-shi, Wakayama, Japan, 6408158
        • Local Institution
  • Korea, Republic of
      • Busan, Korea, Republic of, 602-739
        • Local Institution
      • Busan, Korea, Republic of, 614-735
        • Local Institution
      • Daegu, Korea, Republic of, 700-721
        • Local Institution
      • Daegu, Korea, Republic of, 705-703
        • Local Institution
      • Gyeonggi-do, Korea, Republic of, 425-707
        • Local Institution
      • Gyeonggi-do, Korea, Republic of, 443-380
        • Local Institution
      • Gyeongsangnam-do, Korea, Republic of, 626-770
        • Local Institution
      • Incheon, Korea, Republic of, 400-711
        • Local Institution
      • Incheon, Korea, Republic of, 403-720
        • Local Institution
      • Seoul, Korea, Republic of, 120-752
        • Local Institution
      • Seoul, Korea, Republic of, 135-710
        • Local Institution
      • Seoul, Korea, Republic of, 138-736
        • Local Institution
  • Mexico
      • Distrito Federal, Mexico, 03720
        • Local Institution
      • Guadalajara, Mexico
        • Local Institution
      • Mexico City, Mexico, 06700
        • Local Institution
    • Distrito Federal
      • Mexico, Distrito Federal, Mexico, 07760
        • Local Institution
      • Mexico City, Distrito Federal, Mexico, 06726
        • Local Institution
      • Tlalpan, Distrito Federal, Mexico, 14000
        • Local Institution
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44650
        • Local Institution
      • Guadalajara, Jalisco, Mexico, 44500
        • Local Institution
  • Netherlands
      • Amsterdam, Netherlands, 1105 AZ
        • Local Institution
      • Leiden, Netherlands, 2333 ZA
        • Local Institution
  • New Zealand
      • Auckland, New Zealand, 92024
        • Local Institution
  • Russian Federation
      • Chelyabinsk, Russian Federation, 454052
        • Local Institution
      • Irkutsk, Russian Federation, 664003
        • Local Institution
      • Krasnoyarsk, Russian Federation, 660049
        • Local Institution
      • Moscow, Russian Federation, 119992
        • Local Institution
      • Moscow, Russian Federation, 121170
        • Local Institution
      • Moscow, Russian Federation, 117593
        • Local Institution
      • Moscow, Russian Federation, 107996
        • Local Institution
      • Saint-Petersburg, Russian Federation, 190103
        • Local Institution
      • Saint-Petersburg, Russian Federation, 197376
        • Local Institution
      • Samara, Russian Federation, 443063
        • Local Institution
      • Smolensk, Russian Federation, 214018
        • Local Institution
      • St. Petersburg, Russian Federation, 194044
        • Local Institution
  • Singapore
      • Singapore, Singapore, 529889
        • Local Institution
      • Singapore, Singapore, 169608
        • Local Institution
      • Singapore, Singapore, 119228
        • Local Institution
  • Taiwan
      • Kaohsiung, Taiwan, 833
        • Local Institution
      • Kaohsiung, Taiwan, 80756
        • Local Institution
      • Taichung, Taiwan, 402
        • Local Institution
      • Tainan, Taiwan, 704
        • Local Institution
      • Yunlin, Taiwan, 64041
        • Local Institution
  • United Kingdom
      • London, United Kingdom, E1 1BB
        • Local Institution
    • Humberside
      • Hull, Humberside, United Kingdom, HU3 2JZ
        • Local Institution
    • Nottinghamshire
      • Nottingham, Nottinghamshire, United Kingdom, NG7 2UH
        • Local Institution
    • West Midlands
      • Birmingham, West Midlands, United Kingdom, B15 2TH
        • Local Institution
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85054
        • Mayo Clinic Arizona
    • California
      • San Diego, California, United States, 92123
        • Medical Associates Research Group
      • San Diego, California, United States, 92114
        • Precision Research Institute, LLC
      • San Francisco, California, United States, 94118
        • Kaiser Permanente Medical Center
      • San Francisco, California, United States, 94110
        • University Of California, San Francisco/Sf General Hospital
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Yale University School Of Medicine
    • Florida
      • Orlando, Florida, United States, 32803
        • Orlando Immunology Center
      • Orlando, Florida, United States, 32806
        • Orlando Infectious Disease Center
    • Georgia
      • Marietta, Georgia, United States, 30060
        • Gastrointestinal Specialists of Georgia
    • Hawaii
      • Honolulu, Hawaii, United States, 96813
        • The Queen'S Liver Center
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Hospital
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Carolinas Medical Center
    • Ohio
      • Cincinnati, Ohio, United States, 45249
        • Consultants for Clinical Research
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74135
        • Healthcare Research Consultants
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • University Of Pittsburgh Medical Center, Ctr For Liver Diseases
    • Texas
      • Arlington, Texas, United States, 76012
        • Texas Clinical Research Institute, LLC
      • Houston, Texas, United States, 77030
        • St. Luke'S Episcopal Hospital - Baylor College Of Medicine
    • Utah
      • Murray, Utah, United States, 84123
        • Clinical Research Centers Of America

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (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 2 or 3
  • Naïve to prior anti-HCV therapy

Exclusion Criteria:

  • Infected with HCV other than Genotype 2 or 3
  • Positive Hepatitis B surface antigen (HBsAg), or Human immunodeficiency virus-1 (HIV-1)/HIV-2 antibody at screening
  • Evidence of liver disease other than HCV
  • Active substance abuse
  • Evidence of decompensated cirrhosis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1: pegIFNλ + Ribavirin + Placebo matching Daclatasvir
Biological: Pegylated interferon lambda (pegIFNλ)
Syringe, Subcutaneous, 180 μg, Once weekly, 24 weeks
Other Names:
  • BMS-914143
Biological: Pegylated interferon lambda (pegIFNλ)
Syringe, Subcutaneous, 180 μg, Once weekly, 12 weeks
Other Names:
  • BMS-914143
Drug: Ribavirin
Tablets, Oral, 400 mg, Twice daily, 24 weeks
Other Names:
  • Ribasphere
Drug: Ribavirin
Tablets, Oral, 400 mg, Twice daily, 12 weeks
Other Names:
  • Ribasphere
Drug: Placebo matching Daclatasvir
Tablets, Oral, 0 mg, Once daily, 12 weeks
Experimental: Arm 2: pegIFNλ + Ribavirin + Daclatasvir
Biological: Pegylated interferon lambda (pegIFNλ)
Syringe, Subcutaneous, 180 μg, Once weekly, 24 weeks
Other Names:
  • BMS-914143
Biological: Pegylated interferon lambda (pegIFNλ)
Syringe, Subcutaneous, 180 μg, Once weekly, 12 weeks
Other Names:
  • BMS-914143
Drug: Ribavirin
Tablets, Oral, 400 mg, Twice daily, 24 weeks
Other Names:
  • Ribasphere
Drug: Ribavirin
Tablets, Oral, 400 mg, Twice daily, 12 weeks
Other Names:
  • Ribasphere
Drug: Daclatasvir
Tablets, Oral, 60 mg, Once daily, 12 weeks
Other Names:
  • BMS-790052
Experimental: Arm 3: pegIFNα-2a + Ribavirin + Placebo matching Daclatasvir
Drug: Ribavirin
Tablets, Oral, 400 mg, Twice daily, 24 weeks
Other Names:
  • Ribasphere
Drug: Ribavirin
Tablets, Oral, 400 mg, Twice daily, 12 weeks
Other Names:
  • Ribasphere
Drug: Placebo matching Daclatasvir
Tablets, Oral, 0 mg, Once daily, 12 weeks
Biological: Pegylated interferon alfa-2a (pegIFNα-2a)
Syringe, Subcutaneous, 180 μg, Once weekly, 24 weeks
Other Names:
  • Pegasys

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of subjects who achieve Sustained Virologic Response at post-treatment follow-up week 12 (SVR12)
Time Frame: Post-treatment follow-up week 12
Post-treatment follow-up week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of subjects with Rapid virologic response (RVR) [undetectable Hepatitis C virus (HCV) Ribonucleic acid (RNA)]
Time Frame: On-treatment Week 4
On-treatment Week 4
Proportion of subjects with treatment emergent cytopenic abnormalities (anemia as defined by Hb < 10 g/dL, neutropenia as defined by ANC < 750 mm3 or thrombocytopenia as defined by platelets < 50,000 mm3)
Time Frame: Up to week 12 or week 24
Hb = Hemoglobin ANC = Absolute neutrophil count
Up to week 12 or week 24
Proportion of subjects with on-treatment interferon-associated flu-like symptoms (as defined by pyrexia or chills or pain)
Time Frame: Up to week 12 or week 24
Up to week 12 or week 24
Proportion of subjects with on-treatment musculoskeletal symptoms (as defined by arthralgia or myalgia or back pain)
Time Frame: Up to week 12 or week 24
Up to week 12 or week 24
Proportion of subjects with Sustained Virologic Response at post-treatment follow-up week 24 (SVR24) by treatment group
Time Frame: Post-treatment week 24
Post-treatment week 24
Proportion of subjects with on-treatment Serious adverse events (SAEs)
Time Frame: Up to week 12 or week 24
Up to week 12 or week 24
Proportion of subjects with dose reductions
Time Frame: Up to week 12 or week 24
Up to week 12 or week 24
Proportion of subjects who discontinue due to Adverse events (AEs)
Time Frame: Up to week 12 or week 24
Up to week 12 or week 24
Proportion of subjects with SVR12 in subjects with genotype-3 (GT-3) chronic HCV infection
Time Frame: Post-treatment follow-up week 12
Post-treatment follow-up week 12
Proportion of subjects with on-treatment constitutional symptoms (fatigue or asthenia)
Time Frame: Up to week 12 or week 24
Up to week 12 or week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2012

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

June 7, 2012

First Submitted That Met QC Criteria

June 7, 2012

First Posted (Estimate)

June 11, 2012

Study Record Updates

Last Update Posted (Estimate)

October 9, 2015

Last Update Submitted That Met QC Criteria

September 23, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AI452-017
  • 2011-004885-14 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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