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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. Identifier: NCT00759200
Recruitment Status : Completed
First Posted : September 25, 2008
Last Update Posted : November 16, 2016
Human Genome Sciences Inc.
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Brief Summary:
This study will evaluate the safety and efficacy of alb-interferon in adults with genotype 2 or 3 chronic hepatitis

Condition or disease Intervention/treatment Phase
Chronic Hepatitis C Drug: alb-interferon alfa 2b Drug: peg-interferon Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 525 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : October 2008
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Interferon

Arm Intervention/treatment
Experimental: alb-interferon arm 1 Drug: alb-interferon alfa 2b
900 mcg every 4 weeks
Other Name: ABF656

Experimental: alb-interferon arm 2 Drug: alb-interferon alfa 2b
1200 mcg every 4 weeks
Other Name: ABF656

Experimental: alb-interferon arm 3 Drug: alb-interferon alfa 2b
1500 mcg every 4 weeks
Other Name: ABF656

Experimental: alb-interferon arm 4 Drug: alb-interferon alfa 2b
1800 mcg every 4 weeks
Other Name: ABF656

Active Comparator: peg-interferon Drug: peg-interferon
Peg-interferon alfa 2a: 180 mcg 1x per wk.
Other Name: peg-IFN

Primary Outcome Measures :
  1. Adverse events [ Time Frame: at every visit ]

Secondary Outcome Measures :
  1. Viral load [ Time Frame: at weeks 4, 12 and 24 of treatment and 24 weeks post-treatment. ]

Information from the National Library of Medicine

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

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.

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 identifier (NCT number): NCT00759200

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Sponsors and Collaborators
Human Genome Sciences Inc.
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Publications of Results:
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Responsible Party: External Affairs, Novartis Identifier: NCT00759200    
Other Study ID Numbers: CABF656B2202
First Posted: September 25, 2008    Key Record Dates
Last Update Posted: November 16, 2016
Last Verified: April 2011
Keywords provided by Novartis:
Chronic hepatitis C
genotype 2
genotype 3
albumin interferon alfa-2b
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Hepatitis, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Interferon alpha-2
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs