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A Study of Albuferon With Ribavirin in Interferon Treatment Experienced Subjects With Chronic Hepatitis C

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: NCT00097435
Recruitment Status : Completed
First Posted : November 24, 2004
Last Update Posted : August 2, 2013
Sponsor:
Information provided by (Responsible Party):
Human Genome Sciences Inc.

Study Description
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Brief Summary:
This is a Phase 2, multi-center, randomized, open-label study to evaluate the safety, tolerability, and efficacy of Albuferon in subjects with hepatitis C (HEP C) who failed to respond to previous interferon alfa therapy.

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 115 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multi-Center, Randomized, Open-Label Study to Evaluate the Safety, Tolerability, and Efficacy of Albuferon (Recombinant Human Albumin-Interferon Alfa Fusion Protein) in Combination With Ribavirin in Interferon Treatment Experienced Subjects With Chronic Hepatitis C
Study Start Date : October 2004
Actual Primary Completion Date : August 2007
Actual Study Completion Date : August 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. The major safety endpoints are the common side effects of IFNa therapy including flu-like symptoms, depression, and hematologic abnormalities.

Secondary Outcome Measures :
  1. Sustained virologic response (SVR), defined as undetectable virus at 24 weeks after the end of therapy. The primary efficacy assessment is HCV RNA level.

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

Major Inclusion Criteria:

  • Have a clinical diagnosis of chronic HEP C established on the basis of detectable viral load, as measured by a serum HCV RNA test during the screening period.
  • Have previously failed to respond to treatment with any interferon alfa (IFNa) product
  • Have compensated liver disease with the following minimum criteria: white blood cell count > 3,000/mm3, absolute neutrophil count (ANC) > 2,000/mm3, platelets > 125,000/mm3, and hemoglobin (Hb) > 13 g/dL for males or > 12 g/dL for females.

Major Exclusion Criteria:

  • Evidence of decompensated cirrhosis or portal hypertension.
  • 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): NCT00097435


Locations
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United States, Arizona
Mayo Clinic
Phoenix, Arizona, United States, 85054
United States, Florida
University of Florida CRC
Gainesville, Florida, United States, 32610
University of Florida at Jacksonville
Jacksonville, Florida, United States, 32209
Mayo Clinic Jacksonville
Jacksonville, Florida, United States, 32216
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21287
United States, Minnesota
Mayo Clinic Rochester
Rochester, Minnesota, United States, 55905
United States, North Carolina
Duke University
Durham, North Carolina, United States, 27710
United States, Virginia
Metropolitan Research
Fairfax, Virginia, United States, 22031
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: Human Genome Sciences Inc.
ClinicalTrials.gov Identifier: NCT00097435    
Other Study ID Numbers: Clinical Protocol ALFR-HC-05
First Posted: November 24, 2004    Key Record Dates
Last Update Posted: August 2, 2013
Last Verified: August 2013
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Hepatitis
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
Hepatitis, Chronic
Ribavirin
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents