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A Study of Albuferon With Ribavirin in Interferon Alfa Naive Subjects With Chronic Hepatitis C Genotype 2 or 3

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: NCT00656006
Recruitment Status : Completed
First Posted : April 10, 2008
Last Update Posted : August 2, 2013
Sponsor:
Information provided by:
Human Genome Sciences Inc.

Study Description
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Brief Summary:
A Study of Albuferon with Ribavirin in Interferon Alfa Naive Subjects with Chronic Hepatitis C Genotype 2 or 3.

Condition or disease Intervention/treatment Phase
Chronic Hepatitis C Drug: Albuferon Drug: Ribavirin Phase 2

Detailed Description:
A Randomized, Multi-Center, Open-Label Study To Evaluate The Efficacy And Safety Of Albuferon (HGS 1008, Recombinant Human Albumin-Interferon Alfa Fusion Protein) In Combination With Ribavirin In Interferon Alfa Naive Subjects With Chronic Hepatitis C Genotype 2 OR 3
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Multi-Center, Open-Label Study To Evaluate The Efficacy And Safety Of Albuferon (HGS 1008, Recombinant Human Albumin-Interferon Alfa Fusion Protein) In Combination With Ribavirin In Interferon Alfa Naive Subjects With Chronic Hepatitis C Genotype 2 OR 3
Study Start Date : November 2005
Actual Primary Completion Date : April 2007
Actual Study Completion Date : April 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Ribavirin

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Primary safety endpoints are the common side effects of IFNa therapy including flu-like symptoms, depression, and hematologic abnormalities.
  2. Primary efficacy end point is sustained virologic response (SVR), defined as undetectable HCV RNA at 24 weeks after the end of therapy.

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have a clinical diagnosis of chronic hepatitis C on the basis of detectable serum HCV RNA during the screening period and at least a 6-month history of exposure to risk factors for HCV.
  • Have never received treatment with an interferon alfa product or an interferon alfa combination product.
  • Have HCV genotype 2 or 3.
  • Have compensated liver disease with the following minimum criteria: white blood cell count (WBC) >3,000/mm3, absolute neutrophil count (ANC) > 1,800/mm3, platelets >100,000/mm3, hemoglobin (Hb) > 13 g/dL for males and > 12 g/dL for females.

Exclusion Criteria:

  • Evidence of decompensated liver disease.
  • Pregnant or lactating female.
  • History of any other medical disease or condition that would make the subject (in the opinion of the investigator) unsuitable for the study.
  • A current drug or alcohol addiction.
Contacts and Locations
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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): NCT00656006


Locations
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Canada, Alberta
University of Calgary
Calgary, Alberta, Canada, T2N 4N1
University of Alberta
Edmonton, Alberta, Canada, T6G 2X8
Canada, British Columbia
University of British Columbia
Vancouver, British Columbia, Canada, V5Z 3P1
Canada, Manitoba
University of Manitoba
Winnipeg, Manitoba, Canada, R3E 2P4
Canada, Ontario
University of Western Ontario
London, Ontario, Canada, N6A 5A5
Canada, Saskatchewan
University of Saskatchewan
Saskatoon, Saskatchewan, Canada, S7N 0W8
Sponsors and Collaborators
Human Genome Sciences Inc.
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline
More Information
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Responsible Party: Patrick Cronin, Human Genome Sciences
ClinicalTrials.gov Identifier: NCT00656006    
Other Study ID Numbers: HGS1008-C1052 (ALFR-HC-06)
First Posted: April 10, 2008    Key Record Dates
Last Update Posted: August 2, 2013
Last Verified: August 2013
Keywords provided by Human Genome Sciences Inc.:
Hepatitis C
Chronic
Genotype 2 or 3
Treatment naive
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Hepatitis
Hepatitis, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Infections
Enterovirus Infections
 Picornaviridae Infections
RNA Virus Infections
Blood-Borne Infections
Communicable Diseases
Flaviviridae Infections
Ribavirin
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents