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Safety and Efficacy of Albumin Interferon Administered Every 4 Weeks in Genotype 2/3 Hepatitis C Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00759200
Recruitment Status : Completed
First Posted : September 25, 2008
Last Update Posted : November 16, 2016
Sponsor:
Collaborator:
Human Genome Sciences Inc.
Information provided by:
Novartis

Tracking Information
First Submitted Date  ICMJE September 23, 2008
First Posted Date  ICMJE September 25, 2008
Last Update Posted Date November 16, 2016
Study Start Date  ICMJE October 2008
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 23, 2008)
Adverse events [ Time Frame: at every visit ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 23, 2008)
Viral load [ Time Frame: at weeks 4, 12 and 24 of treatment and 24 weeks post-treatment. ]
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 of Albumin Interferon Administered Every 4 Weeks in Genotype 2/3 Hepatitis C Patients
Official Title  ICMJE An Open-label, Randomized, Multicenter, Active-controlled, Dose-ranging Study to Evaluate the Safety and Efficacy of Albinterferon Alfa 2b Administered Every 4 Weeks Plus Ribavirin in Interferon Alfa-naïve Patients With Genotype 2/3 Chronic Hepatitis C
Brief Summary This study will evaluate the safety and efficacy of alb-interferon in adults with genotype 2 or 3 chronic hepatitis
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Chronic Hepatitis C
Intervention  ICMJE
  • Drug: alb-interferon alfa 2b
    900 mcg every 4 weeks
    Other Name: ABF656
  • Drug: alb-interferon alfa 2b
    1200 mcg every 4 weeks
    Other Name: ABF656
  • Drug: alb-interferon alfa 2b
    1500 mcg every 4 weeks
    Other Name: ABF656
  • Drug: alb-interferon alfa 2b
    1800 mcg every 4 weeks
    Other Name: ABF656
  • Drug: peg-interferon
    Peg-interferon alfa 2a: 180 mcg 1x per wk.
    Other Name: peg-IFN
Study Arms  ICMJE
  • Experimental: alb-interferon arm 1
    Intervention: Drug: alb-interferon alfa 2b
  • Experimental: alb-interferon arm 2
    Intervention: Drug: alb-interferon alfa 2b
  • Experimental: alb-interferon arm 3
    Intervention: Drug: alb-interferon alfa 2b
  • Experimental: alb-interferon arm 4
    Intervention: Drug: alb-interferon alfa 2b
  • Active Comparator: peg-interferon
    Intervention: Drug: peg-interferon
Publications * Pianko S, Zeuzem S, Chuang WL, Foster GR, Sarin SK, Flisiak R, Lee CM, Andreone P, Piratvisuth T, Shah S, Sood A, George J, Gould M, Komolmit P, Thongsawat S, Tanwandee T, Rasenack J, Li Y, Pang M, Yin Y, Feutren G, Jacobson IM; B2202 Study Team. Randomized trial of albinterferon alfa-2b every 4 weeks for chronic hepatitis C virus genotype 2/3. J Viral Hepat. 2012 Sep;19(9):623-34. doi: 10.1111/j.1365-2893.2012.01586.x. Epub 2012 Mar 21.

*   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
Estimated Enrollment  ICMJE
 (submitted: September 23, 2008)
525
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2010
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age of 18 years or older
  • Clinical diagnosis of chronic hepatitis C
  • Infection with HCV genotype 2 or 3
  • No previous IFNα-based therapy

Exclusion Criteria:

  • Women of child-bearing potential if not using double barrier method of contraception, pregnant or nursing
  • Fertile males, unless condom with spermicide is used and female partner agrees to use one or more of the acceptable methods until 7 months after last dose of RBV
  • History or current evidence of decompensated liver disease; other forms of liver disease
  • Coinfection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
  • History of moderate, severe or uncontrolled psychiatric disease
  • History of seizure disorder
  • History or clinical evidence of chronic cardiac disease, preexisting interstitial lung disease or severe lung disease
  • Clinically significant findings on eye/retinal examination
  • History of immunologically mediated disease
  • Organ transplantation other than cornea or hair transplant
  • History of clinically significant hemoglobinopathy
  • Diagnosis of malignancy of any organ system with the exception of localized basal cell carcinoma of the skin
  • History of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
  • History of hypersensitivity to any of the study drugs or to drugs with similar chemical structures
  • Drug or alcohol addiction within the last 6 months and/or positive drug screening tests
  • Received systemic corticosteroids (prednisone equivalent of > 10 mg/day) within 14 days prior to Baseline visit
  • Received concomitant systemic antibiotics, antifungals or antivirals for the treatment of active infection within 14 days prior to Baseline visit.
  • Received herbal therapies (including milk thistle or glycyrrhizin) or an investigational drug within 35 days prior to Baseline visit
  • Have a clinically significant laboratory abnormality

Other protocol-defined inclusion/exclusion criteria may apply.

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 Australia,   Canada,   France,   Germany,   Greece,   India,   Italy,   Poland,   Spain,   Taiwan,   Thailand,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00759200
Other Study ID Numbers  ICMJE CABF656B2202
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party External Affairs, Novartis
Study Sponsor  ICMJE Novartis
Collaborators  ICMJE Human Genome Sciences Inc.
Investigators  ICMJE
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
PRS Account Novartis
Verification Date April 2011

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