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

NCT01616524 | Completed Phase 3

• 2 other identifiers: AI452-0172011-004885-14
• Study Type: interventional
• Target: 880
• Locations: 19 countries
• Sites: 124

Brief Summary

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

Conditions

Hepatitis C Virus (HCV)

Outcome Measures

Primary Outcomes (1)

• Proportion of subjects who achieve Sustained Virologic Response at post-treatment follow-up week 12 (SVR12)

  Post-treatment follow-up week 12

Secondary Outcomes (10)

• Proportion of subjects with Rapid virologic response (RVR) [undetectable Hepatitis C virus (HCV) Ribonucleic acid (RNA)]

  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)

  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)

  Up to week 12 or week 24

• Proportion of subjects with on-treatment musculoskeletal symptoms (as defined by arthralgia or myalgia or back pain)

  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

  Post-treatment week 24

Study Arms (3)

Arm 1: pegIFNλ + Ribavirin + Placebo matching Daclatasvir

EXPERIMENTAL

Biological: Pegylated interferon lambda (pegIFNλ); Drug: Ribavirin; Drug: Placebo matching Daclatasvir

Arm 2: pegIFNλ + Ribavirin + Daclatasvir

EXPERIMENTAL

Biological: Pegylated interferon lambda (pegIFNλ); Drug: Ribavirin; Drug: Daclatasvir

Arm 3: pegIFNα-2a + Ribavirin + Placebo matching Daclatasvir

EXPERIMENTAL

Biological: Pegylated interferon alfa-2a (pegIFNα-2a); Drug: Ribavirin; Drug: Placebo matching Daclatasvir

Interventions

Pegylated interferon lambda (pegIFNλ) BIOLOGICAL

Syringe, Subcutaneous, 180 μg, Once weekly, 24 weeks

Also known as: BMS-914143

Arm 1: pegIFNλ + Ribavirin + Placebo matching Daclatasvir

Pegylated interferon alfa-2a (pegIFNα-2a) BIOLOGICAL

Syringe, Subcutaneous, 180 μg, Once weekly, 24 weeks

Also known as: Pegasys

Arm 3: pegIFNα-2a + Ribavirin + Placebo matching Daclatasvir

Ribavirin DRUG

Tablets, Oral, 400 mg, Twice daily, 24 weeks

Also known as: Ribasphere

Arm 1: pegIFNλ + Ribavirin + Placebo matching Daclatasvir; Arm 3: pegIFNα-2a + Ribavirin + Placebo matching Daclatasvir

Daclatasvir DRUG

Tablets, Oral, 60 mg, Once daily, 12 weeks

Also known as: BMS-790052

Arm 2: pegIFNλ + Ribavirin + Daclatasvir

Placebo matching Daclatasvir DRUG

Tablets, Oral, 0 mg, Once daily, 12 weeks

Arm 1: pegIFNλ + Ribavirin + Placebo matching Daclatasvir; Arm 3: pegIFNα-2a + Ribavirin + Placebo matching Daclatasvir

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Chronic hepatitis C, Genotype 2 or 3
• Naïve to prior anti-HCV therapy

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (124)

Mayo Clinic Arizona

Phoenix, Arizona, 85054, United States

Location

Precision Research Institute, Llc

San Diego, California, 92114, United States

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Medical Associates Research Group

San Diego, California, 92123, United States

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University Of California, San Francisco/Sf General Hospital

San Francisco, California, 94110, United States

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Kaiser Permanente Medical Center

San Francisco, California, 94118, United States

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Yale University School Of Medicine

New Haven, Connecticut, 06510, United States

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Orlando Immunology Center

Orlando, Florida, 32803, United States

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Orlando Infectious Disease Center

Orlando, Florida, 32806, United States

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Gastrointestinal Specialists Of Georgia

Marietta, Georgia, 30060, United States

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The Queen'S Liver Center

Honolulu, Hawaii, 96813, United States

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Henry Ford Hospital

Detroit, Michigan, 48202, United States

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Carolinas Medical Center

Charlotte, North Carolina, 28204, United States

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Consultants For Clinical Research

Cincinnati, Ohio, 45249, United States

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Healthcare Research Consultants

Tulsa, Oklahoma, 74135, United States

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University Of Pittsburgh Medical Center, Ctr For Liver Diseases

Pittsburgh, Pennsylvania, 15213, United States

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Texas Clinical Research Institute, Llc

Arlington, Texas, 76012, United States

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St. Luke'S Episcopal Hospital - Baylor College Of Medicine

Houston, Texas, 77030, United States

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Clinical Research Centers Of America

Murray, Utah, 84123, United States

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Local Institution

Autonoma, Buenos Aires, C1119ACN, Argentina

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Buenos Aires, Buenos Aires, C1280AEB, Argentina

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Ciudad de Buenos Aires, Buenos Aires, C1121ABE, Argentina

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Ciudad de Buenos Aires, Buenos Aires, C1181ACH, Argentina

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Mar del Plata, Buenos Aires, 7600, Argentina

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Quilmes, Buenos Aires, B1878DVB, Argentina

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Córdoba, Córdoba Province, 5000, Argentina

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Prov de Santa Fe, Santa Fe Province, 2000, Argentina

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Camperdown, New South Wales, 2050, Australia

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Concord, New South Wales, 2139, Australia

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Darlinghurst, New South Wales, 2010, Australia

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Randwick, New South Wales, 2031, Australia

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Westmead Nsw, New South Wales, 2145, Australia

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Brisbane, Queensland, 4102, Australia

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Greenslopes, Queensland, 4120, Australia

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Herston, Queensland, 4029, Australia

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Adelaide, South Australia, 5000, Australia

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Clayton Vic, Victoria, 3168, Australia

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Fitzroy, Victoria, 3065 VIC, Australia

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Melbourne, Victoria, 3004, Australia

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Parville, Victoria, 3050, Australia

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Fremantle, Western Australia, 6160, Australia

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Brussels, 1070, Belgium

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Leuven, 3000, Belgium

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Liège, 4000, Belgium

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Santiago, Santiago Metropolitan, Chile

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Hus, 00029, Finland

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Clichy, 92118, France

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Créteil, 94010, France

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Montpellier, 34295, France

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Nice, 06202, France

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Athens, 115 23, Greece

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Thessaloniki, 54006, Greece

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Hong Kong, Hong Kong

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Tai Po, Hong Kong

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Florence, 50134, Italy

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Milan, 20122, Italy

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Milan, 20142, Italy

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Napoli, 80131, Italy

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Novara, 28100, Italy

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Fukuoka, Fukuoka, 8108563, Japan

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Fukuoka, Fukuoka, 8158555, Japan

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Kitakyushu, Fukuoka, 8030816, Japan

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Hiroshima, Hiroshima, 7348551, Japan

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Sapporo, Hokkaido, 0600033, Japan

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Kobe, Hyōgo, 6500047, Japan

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Tsuchiura-shi, Ibaraki, 300-0053, Japan

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Takamatsu, Kagawa-ken, 7608557, Japan

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Kagoshima, Kagoshima-ken, 8908520, Japan

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Kawasaki-shi, Kanagawa, 2138587, Japan

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Miyazaki, Miyazaki, 8800003, Japan

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Okayama, Okayama-ken, 7008558, Japan

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Saga, Saga-ken, 8408571, Japan

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Iruma-gun, Saitama, 3500495, Japan

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Saitama, Saitama, 3380001, Japan

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Bunkyo-ku, Tokyo, 1138655, Japan

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Minato-ku, Tokyo, 1058470, Japan

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Musashino-shi, Tokyo, 1808610, Japan

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Wakayama, Wakayama, 6408158, Japan

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Guadalajara, Jalisco, 44500, Mexico

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Guadalajara, Jalisco, 44650, Mexico

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Distrito Federal, Mexico City, 03720, Mexico

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Mexico City, Mexico City, 06726, Mexico

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Mexico City, Mexico City, 07760, Mexico

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Tlalpan, Mexico City, 14000, Mexico

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Guadalajara, Mexico

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Mexico City, 06700, Mexico

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Amsterdam, 1105 AZ, Netherlands

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Leiden, 2333 ZA, Netherlands

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Auckland, 92024, New Zealand

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Chelyabinsk, 454052, Russia

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Irkutsk, 664003, Russia

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Krasnoyarsk, 660049, Russia

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Moscow, 107996, Russia

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Moscow, 117593, Russia

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Moscow, 119992, Russia

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Moscow, 121170, Russia

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Saint Petersburg, 190103, Russia

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Saint Petersburg, 194044, Russia

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Saint Petersburg, 197376, Russia

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Samara, 443063, Russia

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Smolensk, 214018, Russia

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Singapore, 119228, Singapore

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Singapore, 169608, Singapore

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Singapore, 529889, Singapore

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Busan, 602-739, South Korea

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Busan, 614-735, South Korea

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Daegu, 700-721, South Korea

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Daegu, 705-703, South Korea

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Gyeonggi-do, 425-707, South Korea

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Gyeonggi-do, 443-380, South Korea

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Gyeongsangnam-do, 626-770, South Korea

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Incheon, 400-711, South Korea

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Incheon, 403-720, South Korea

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Seoul, 120-752, South Korea

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Seoul, 135-710, South Korea

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Seoul, 138-736, South Korea

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Kaohsiung City, 80756, Taiwan

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Kaohsiung City, 833, Taiwan

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Taichung, 402, Taiwan

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Tainan, 704, Taiwan

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Yunlin, 64041, Taiwan

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Hull, Humberside, HU3 2JZ, United Kingdom

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Nottingham, Nottinghamshire, NG7 2UH, United Kingdom

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Birmingham, West Midlands, B15 2TH, United Kingdom

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London, E1 1BB, United Kingdom

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Related Links

• BMS clinical trial educational resource
• Investigator Inquiry form

MeSH Terms

Conditions

Hepatitis C

Interventions

peginterferon lambda-1a; peginterferon alfa-2a; Ribavirin; daclatasvir

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

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: June 7, 2012
• First Posted: June 11, 2012
• Study Start: July 1, 2012
• Primary Completion: June 1, 2014
• Study Completion: September 1, 2014
• Last Updated: October 9, 2015

Record last verified: 2015-09

Locations

GR (2); HK (2); CL (1); AU (14); RU (12); ME (8); KR (12); GB (4); SG (3); BE (3); AR (8); FI (1); NZ (1); IT (5); JP (19); FR (4); TW (5); US (18); NL (2)