Safety and Efficacy Study of Pegylated Interferon Lambda Versus Pegylated Interferon Alfa, Plus Ribavirin in Subjects With Hepatitis C

NCT01447394 | Withdrawn Phase 3

• 2 other identifiers: AI452-0132011-003748-31
• Study Type: interventional
• Target: N/A
• Locations: 20 countries
• Sites: 100

Brief Summary

The purpose of this study is to determine if 48 weeks of therapy with Pegylated Interferon Lambda plus Ribavirin is effective and safe for a treatment of chronic hepatitis C (CHC) compared to therapy with Pegylated Interferon Alfa-2a plus Ribavirin.

Conditions

Hepatitis C Virus (HCV)

Outcome Measures

Primary Outcomes (2)

• Efficacy of Lambda + Ribavirin (RBV) compared to Alfa + RBV in achieving a sustained virological response

  At follow-up Week 24 (SVR24) following 48 weeks of treatment

• The safety of Lambda + RBV compared to Alfa + RBV in reducing cytopenic abnormalities

  From Day 1 to end of Week 48 on-treatment

Secondary Outcomes (1)

• Proportion of interferon-associated symptoms: a) Flu-like symptoms b) Musculoskeletal symptoms c) Neurologic symptoms d) Psychiatric symptoms e) Constitutional symptoms

  From Day 1 to end of Week 48 on-treatment

Study Arms (2)

Arm 1: Pegylated Interferon Lambda + Ribavirin

EXPERIMENTAL

Biological: Pegylated Interferon Lambda; Drug: Ribavirin

Arm 2: Pegylated Interferon Alfa-2a + Ribavirin

ACTIVE COMPARATOR

Biological: Pegylated Interferon Alfa-2a; Drug: Ribavirin

Interventions

Pegylated Interferon Lambda BIOLOGICAL

Syringe, Subcutaneous, 180 μg, Once weekly, 48 weeks

Also known as: BMS-914143

Arm 1: Pegylated Interferon Lambda + Ribavirin

Pegylated Interferon Alfa-2a BIOLOGICAL

Syringe, Subcutaneous, 180 μg, Once weekly, 48 weeks

Also known as: Pegasys

Arm 2: Pegylated Interferon Alfa-2a + Ribavirin

Ribavirin DRUG

Tablets, Oral, 1000 or 1200 mg based on weight, Twice daily, 48 weeks

Also known as: Ribasphere

Arm 1: Pegylated Interferon Lambda + Ribavirin; Arm 2: Pegylated Interferon Alfa-2a + Ribavirin

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Chronic hepatitis C, Genotype 1 or 4
• HCV Ribonucleic acid (RNA) ≥ 100,000 IU/mL at screening
• Liver biopsy documenting no cirrhosis (within prior 2 years) or cirrhosis (from any time prior to randomization). Where approved for staging of liver disease, non-invasive imaging may be used to assess the extent of liver disease. Subjects with compensated cirrhosis can enroll and will be capped at 10%
• Naive to prior anti-HCV therapy

You may not qualify if:

• Infected with HCV other than Genotype 1 or 4
• Positive Hepatitis B surface antigen (HBsAg), or Human immunodeficiency virus-1 (HIV-1)/HIV-2 antibody or hepatitis D virus (HDV) at screening
• Evidence of liver disease other than HCV
• Active substance abuse
• Use of hematologic growth factors within 90 days prior to study randomization
• Evidence of decompensated cirrhosis based on radiologic criteria or biopsy results and clinical criteria

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (100)

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San Diego, California, 92114, United States

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Rochester, New York, 14642, United States

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Houston, Texas, 77230, United States

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Vancouver, British Columbia, V5Z 1H2, Canada

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Vaughan, Ontario, L4L 4Y7, Canada

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Hong Kong, Hong Kong, 0, China

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Bogotá, Colombia

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Cali, Colombia

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Medellín, Colombia

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Hradec Králové, 500 05, Czechia

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Prague, 140 21, Czechia

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Ústí nad Labem, 400 01, Czechia

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Shebin Elkom, Monufia Governorate, 35111, Egypt

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Cairo, 11559, Egypt

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Lai Chi Kok, Hong Kong

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Tai Po, Hong Kong

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Budapest, 1097, Hungary

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Budapest, 1126, Hungary

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Debrecen, 4043, Hungary

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Miskolc, 3529, Hungary

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Hyderabad, Andhra Pradesh, 500082, India

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Coimbatore, 641005, India

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Gūrgaon, 122001, India

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Ludhiana, 141001, India

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Nagpur, 440010, India

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New Delhi, 110 070, India

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Dublin, Dublin, DUBLIN 7, Ireland

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Dublin, Dublin, Ireland

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Amsterdam, 1105 AZ, Netherlands

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Leiden, 2300, Netherlands

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Bialystok, 15-540, Poland

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Bydgoszcz, 85-030, Poland

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Chorzów, 41-500, Poland

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Czeladź, 41-250, Poland

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Kielce, 25-317, Poland

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Krakow, 31-501, Poland

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Lodz, 91-347, Poland

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Lublin, 20-081, Poland

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Olsztyn, 10-082, Poland

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Puławy, 24-100, Poland

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Racibórz, 47-400, Poland

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Sosnowiec, 41-200, Poland

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Warsaw, 01-201, Poland

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Wroclaw, 50-220, Poland

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Zielona Góra, 65-046, Poland

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Bucharest, 021105, Romania

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Iași, 700506, Romania

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Timișoara, 300002, Romania

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Yoshkar-Ola, Mariy-El Republic, 424006, Russia

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Kaluga, 248023, Russia

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Lipetsk, 398043, Russia

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Moscow, 111123, Russia

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Moscow, 115446, Russia

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Moscow, 117333, Russia

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Nizhny Novgorod, 603022, Russia

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Poselok Noviy, 143420, Russia

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Saint Petersburg, 191167, Russia

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Saint Petersburg, 193137, Russia

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Saint Petersburg, 194044, Russia

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Saint Petersburg, 196645, Russia

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Saint Petersburg, 198103, Russia

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Samara, 443077, Russia

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Saratov, 410009, Russia

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Smolensk, 214006, Russia

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Smolensk, 214018, Russia

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Tolyatti, 445846, Russia

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Volgograd, 400040, Russia

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Singapore, 119228, Singapore

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Singapore, 169608, Singapore

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Singapore, 308433, Singapore

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Singapore, 529889, Singapore

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Busan, 609-735, South Korea

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Busan, 614-735, South Korea

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Daegu, 700-721, 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, 110-744, 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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Suwon, 443-721, South Korea

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A Coruña, 15006, Spain

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Barcelona, 08003, Spain

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Barcelona, 08035, Spain

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Barcelona, 08036, Spain

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Madrid, 28046, Spain

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Taipei, Taiwan, 100, Taiwan

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Kaohsiung City, 80756, Taiwan

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Kaohsiung City, 833, Taiwan

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Taichung, 404, Taiwan

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Tainan, 704, Taiwan

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Taipei, 112, Taiwan

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Ankara, 06100, Turkey (Türkiye)

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Bornova Izmir, 35100, Turkey (Türkiye)

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Diyarbakır, 21280, Turkey (Türkiye)

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Istanbul, 34093, Turkey (Türkiye)

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Trabzon, 61080, Turkey (Türkiye)

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London, Greater London, W2 1NY, United Kingdom

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Edinburgh, Midlothian, EH4 2XU, United Kingdom

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Birmingham, West Midlands, B15 2TH, United Kingdom

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Related Links

• Investigator Inquiry form

MeSH Terms

Conditions

Hepatitis C

Interventions

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

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: October 4, 2011
• First Posted: October 6, 2011
• Study Start: March 1, 2012
• Primary Completion: March 1, 2014
• Study Completion: August 1, 2014
• Last Updated: February 3, 2012

Record last verified: 2012-02

Locations

CN (1); IN (6); IE (2); CA (2); US (3); SG (4); HU (4); RU (19); NL (2); TU (5); CZ (3); GB (3); TW (6); CO (3); HK (2); EG (2); PL (15); RO (3); KR (10); ES (5)