Safety and Efficacy Study of Pegylated Interferon Lambda Versus Pegylated Interferon Alfa, Plus Ribavirin in Subjects With Hepatitis C
NCT ID: NCT01447394
Last Updated: 2012-02-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE3
INTERVENTIONAL
2012-03-31
2014-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Arm 1: Pegylated Interferon Lambda + Ribavirin
Pegylated Interferon Lambda
Syringe, Subcutaneous, 180 μg, Once weekly, 48 weeks
Ribavirin
Tablets, Oral, 1000 or 1200 mg based on weight, Twice daily, 48 weeks
Arm 2: Pegylated Interferon Alfa-2a + Ribavirin
Pegylated Interferon Alfa-2a
Syringe, Subcutaneous, 180 μg, Once weekly, 48 weeks
Ribavirin
Tablets, Oral, 1000 or 1200 mg based on weight, Twice daily, 48 weeks
Interventions
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Pegylated Interferon Lambda
Syringe, Subcutaneous, 180 μg, Once weekly, 48 weeks
Pegylated Interferon Alfa-2a
Syringe, Subcutaneous, 180 μg, Once weekly, 48 weeks
Ribavirin
Tablets, Oral, 1000 or 1200 mg based on weight, Twice daily, 48 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
70 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Local Institution
San Diego, California, United States
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Rochester, New York, United States
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Houston, Texas, United States
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Vancouver, British Columbia, Canada
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Vaughan, Ontario, Canada
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Hong Kong, Hong Kong, 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, , Czechia
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Prague, , Czechia
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Ústí nad Labem, , Czechia
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Shebin Elkom, Monufia Governorate, Egypt
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Cairo, , Egypt
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Lai Chi Kok, , Hong Kong
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Tai Po, , Hong Kong
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Budapest, , Hungary
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Budapest, , Hungary
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Debrecen, , Hungary
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Miskolc, , Hungary
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Hyderabad, Andhra Pradesh, India
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Coimbatore, , India
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Gurgaon, , India
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Ludhiana, , India
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Nagpur, , India
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New Delhi, , India
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Dublin, Dublin, Ireland
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Dublin, Dublin, Ireland
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Amsterdam, , Netherlands
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Leiden, , Netherlands
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Bialystok, , Poland
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Bydgoszcz, , Poland
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Chorzów, , Poland
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Czeladź, , Poland
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Kielce, , Poland
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Krakow, , Poland
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Lodz, , Poland
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Lublin, , Poland
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Olsztyn, , Poland
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Puławy, , Poland
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Racibórz, , Poland
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Sosnowiec, , Poland
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Warsaw, , Poland
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Wroclaw, , Poland
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Zielona Góra, , Poland
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Bucharest, , Romania
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Iași, , Romania
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Timișoara, , Romania
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Yoshkar-Ola, Mariy-El Republic, Russia
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Kaluga, , Russia
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Lipetsk, , Russia
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Moscow, , Russia
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Moscow, , Russia
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Moscow, , Russia
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Nizhny Novgorod, , Russia
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Poselok Noviy, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Samara, , Russia
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Saratov, , Russia
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Smolensk, , Russia
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Smolensk, , Russia
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Tolyatti, , Russia
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Volgograd, , Russia
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Singapore, , Singapore
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Singapore, , Singapore
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Singapore, , Singapore
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Singapore, , Singapore
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Busan, , South Korea
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Busan, , South Korea
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Daegu, , South Korea
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Incheon, , South Korea
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Incheon, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Suwon, , South Korea
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A Coruña, , Spain
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Barcelona, , Spain
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Barcelona, , Spain
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Barcelona, , Spain
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Madrid, , Spain
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Taipei, Taiwan, Taiwan
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Kaohsiung City, , Taiwan
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Kaohsiung City, , Taiwan
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Taichung, , Taiwan
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Tainan City, , Taiwan
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Taipei, , Taiwan
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Ankara, , Turkey (Türkiye)
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Bornova Izmir, , Turkey (Türkiye)
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Diyarbakır, , Turkey (Türkiye)
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Istanbul, , Turkey (Türkiye)
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Trabzon, , Turkey (Türkiye)
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London, Greater London, United Kingdom
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Edinburgh, Midlothian, United Kingdom
Local Institution
Birmingham, West Midlands, United Kingdom
Countries
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Related Links
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Investigator Inquiry form
Other Identifiers
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2011-003748-31
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
AI452-013
Identifier Type: -
Identifier Source: org_study_id
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