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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline ( Human Genome Sciences Inc., a GSK Company )
ClinicalTrials.gov Identifier:
NCT00097435
First received: November 23, 2004
Last updated: October 29, 2012
Last verified: October 2012
History of Changes
  Purpose

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 Intervention Phase
Hepatitis C
 Drug: Albuferon
Drug: Ribavirin
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • The major safety endpoints are the common side effects of IFNa therapy including flu-like symptoms, depression, and hematologic abnormalities.

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

Enrollment: 115
Study Start Date: October 2004
Study Completion Date: August 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00097435

Locations
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., a GSK Company
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline ( Human Genome Sciences Inc., a GSK Company )
ClinicalTrials.gov Identifier: NCT00097435     History of Changes
Other Study ID Numbers: Clinical Protocol ALFR-HC-05
Study First Received: November 23, 2004
Last Updated: October 29, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
 RNA Virus Infections
Flaviviridae Infections
Interferons
Ribavirin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 21, 2013