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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

Tracking Information
First Submitted Date  ICMJE June 7, 2012
First Posted Date  ICMJE June 11, 2012
Last Update Posted Date October 9, 2015
Study Start Date  ICMJE July 2012
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 7, 2012)
Proportion of subjects who achieve Sustained Virologic Response at post-treatment follow-up week 12 (SVR12) [ Time Frame: Post-treatment follow-up week 12 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01616524 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 7, 2012)
  • Proportion of subjects with Rapid virologic response (RVR) [undetectable Hepatitis C virus (HCV) Ribonucleic acid (RNA)] [ Time Frame: 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
  • 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 ]
  • 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 ]
  • Proportion of subjects with Sustained Virologic Response at post-treatment follow-up week 24 (SVR24) by treatment group [ Time Frame: Post-treatment week 24 ]
  • Proportion of subjects with on-treatment Serious adverse events (SAEs) [ Time Frame: Up to week 12 or week 24 ]
  • Proportion of subjects with dose reductions [ Time Frame: 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 ]
  • Proportion of subjects with SVR12 in subjects with genotype-3 (GT-3) chronic HCV infection [ Time Frame: 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Hepatitis C Virus (HCV)
Intervention  ICMJE
  • Biological: Pegylated interferon lambda (pegIFNλ)
    Syringe, Subcutaneous, 180 μg, Once weekly, 24 weeks
    Other Name: BMS-914143
  • Biological: Pegylated interferon lambda (pegIFNλ)
    Syringe, Subcutaneous, 180 μg, Once weekly, 12 weeks
    Other Name: BMS-914143
  • 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: 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
  • Drug: Placebo matching Daclatasvir
    Tablets, Oral, 0 mg, Once daily, 12 weeks
Study Arms  ICMJE
  • Experimental: Arm 1: pegIFNλ + Ribavirin + Placebo matching Daclatasvir
    Interventions:
    • Biological: Pegylated interferon lambda (pegIFNλ)
    • Drug: Ribavirin
    • Drug: Placebo matching Daclatasvir
  • Experimental: Arm 2: pegIFNλ + Ribavirin + Daclatasvir
    Interventions:
    • Biological: Pegylated interferon lambda (pegIFNλ)
    • Drug: Ribavirin
    • Drug: Daclatasvir
  • Experimental: Arm 3: pegIFNα-2a + Ribavirin + Placebo matching Daclatasvir
    Interventions:
    • Biological: Pegylated interferon alfa-2a (pegIFNα-2a)
    • Drug: Ribavirin
    • Drug: Placebo matching Daclatasvir
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 25, 2013)
880
Original Estimated Enrollment  ICMJE
 (submitted: June 7, 2012)
875
Actual Study Completion Date  ICMJE September 2014
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Australia,   Belgium,   Chile,   Finland,   France,   Greece,   Hong Kong,   Italy,   Japan,   Korea, Republic of,   Mexico,   Netherlands,   New Zealand,   Russian Federation,   Singapore,   Taiwan,   United Kingdom,   United States
Removed Location Countries Brazil,   India
 
Administrative Information
NCT Number  ICMJE NCT01616524
Other Study ID Numbers  ICMJE AI452-017
2011-004885-14 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bristol-Myers Squibb
Study Sponsor  ICMJE Bristol-Myers Squibb
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
PRS Account Bristol-Myers Squibb
Verification Date September 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP