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Trial record 71 of 382 for:    IFNA2 AND RBV AND genotype

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)

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ClinicalTrials.gov Identifier: NCT01616524
Recruitment Status : Completed
First Posted : June 11, 2012
Last Update Posted : October 9, 2015
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

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

Condition or disease Intervention/treatment Phase
Hepatitis C Virus (HCV) Biological: Pegylated interferon lambda (pegIFNλ) Biological: Pegylated interferon alfa-2a (pegIFNα-2a) Drug: Ribavirin Drug: Daclatasvir Drug: Placebo matching Daclatasvir Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 880 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : July 2012
Actual Primary Completion Date : June 2014
Actual Study Completion Date : September 2014

Resource links provided by the National Library of Medicine


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 Name: BMS-914143

Drug: Ribavirin
Tablets, Oral, 400 mg, Twice daily, 24 weeks
Other Name: 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, 12 weeks
Other Name: BMS-914143

Drug: Ribavirin
Tablets, Oral, 400 mg, Twice daily, 12 weeks
Other Name: Ribasphere

Drug: Daclatasvir
Tablets, Oral, 60 mg, Once daily, 12 weeks
Other Name: BMS-790052

Experimental: Arm 3: pegIFNα-2a + Ribavirin + Placebo matching Daclatasvir Biological: Pegylated interferon alfa-2a (pegIFNα-2a)
Syringe, Subcutaneous, 180 μg, Once weekly, 24 weeks
Other Name: Pegasys

Drug: Ribavirin
Tablets, Oral, 400 mg, Twice daily, 24 weeks
Other Name: Ribasphere

Drug: Placebo matching Daclatasvir
Tablets, Oral, 0 mg, Once daily, 12 weeks




Primary Outcome Measures :
  1. Proportion of subjects who achieve Sustained Virologic Response at post-treatment follow-up week 12 (SVR12) [ Time Frame: Post-treatment follow-up week 12 ]

Secondary Outcome Measures :
  1. Proportion of subjects with Rapid virologic response (RVR) [undetectable Hepatitis C virus (HCV) Ribonucleic acid (RNA)] [ Time Frame: On-treatment Week 4 ]
  2. 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

  3. 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 ]
  4. 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 ]
  5. Proportion of subjects with Sustained Virologic Response at post-treatment follow-up week 24 (SVR24) by treatment group [ Time Frame: Post-treatment week 24 ]
  6. Proportion of subjects with on-treatment Serious adverse events (SAEs) [ Time Frame: Up to week 12 or week 24 ]
  7. Proportion of subjects with dose reductions [ Time Frame: Up to week 12 or week 24 ]
  8. Proportion of subjects who discontinue due to Adverse events (AEs) [ Time Frame: Up to week 12 or week 24 ]
  9. Proportion of subjects with SVR12 in subjects with genotype-3 (GT-3) chronic HCV infection [ Time Frame: Post-treatment follow-up week 12 ]
  10. Proportion of subjects with on-treatment constitutional symptoms (fatigue or asthenia) [ Time Frame: Up to week 12 or week 24 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01616524


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

Additional Information:
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01616524     History of Changes
Other Study ID Numbers: AI452-017
2011-004885-14 ( EudraCT Number )
First Posted: June 11, 2012    Key Record Dates
Last Update Posted: October 9, 2015
Last Verified: September 2015
Additional relevant MeSH terms:
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Ribavirin
Interferon-alpha
Interferon alpha-2
Hepatitis A
Hepatitis C
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Interferons
Peginterferon alfa-2a
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs