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A Study of Albuferon and Ribavirin in Interferon Naive Subjects With Chronic Hepatitis C Genotype 1

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ClinicalTrials.gov Identifier: NCT00115908
Recruitment Status : Completed
First Posted : June 27, 2005
Last Update Posted : November 7, 2013
Information provided by (Responsible Party):
Human Genome Sciences Inc.

Brief Summary:
The purpose of the study is to evaluate the efficacy and safety of Albuferon in combination with ribavirin in interferon (IFN) alfa treatment-naïve subjects with chronic hepatitis C genotype 1. The study will randomize subjects to 1 of 4 treatment groups including 3 different Albuferon groups or to the active control group, peginterferon alfa-2a (PEGASYS, PEG-IFNalfa-2a). All subjects will also receive oral daily ribavirin.

Condition or disease Intervention/treatment Phase
Hepatitis C, Chronic Drug: Albuferon Drug: Ribavirin Drug: PEG-IFNalfa2a Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 458 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2b, Randomized, Multi-Center, Active-Controlled, Open-Label Study to Evaluate the Efficacy and Safety of Albuferon (Recombinant Human Albumin-Interferon Alfa Fusion Protein) in Combination With Ribavirin in Interferon Alfa Naive Subjects With Chronic Hepatitis C Genotype 1
Study Start Date : May 2005
Primary Completion Date : May 2007
Study Completion Date : May 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Ribavirin
U.S. FDA Resources

Primary Outcome Measures :
  1. Sustained virologic response (SVR), defined as undetectable HCV RNA at 24 weeks after the end of therapy.

Secondary Outcome Measures :
  1. Virologic response at Week 4 (VR4), defined as undetectable HCV RNA or a > 2-log reduction in HCV RNA.
  2. Early virologic response at Week 12 (EVR12), defined as undetectable HCV RNA or a > 2-log reduction in HCV RNA.
  3. Undetectable HCV RNA at Week 24.
  4. End of treatment response (ETR), defined as undetectable HCV RNA at Week 48

Information from the National Library of Medicine

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

Key Inclusion Criteria:

  • Interferon treatment naive subjects with chronic hepatitis C, HCV genotype 1.
  • Compensated liver disease

Key Exclusion Criteria:

  • Pregnant or lactating female or males with a pregnant partner.
  • A positive test for serum antibodies to the human immunodeficiency virus (HIV-1) or serum hepatitis B virus surface antigen (HBsAg).
  • A history of moderate, severe or uncontrolled psychiatric disease.
  • A history of immunologically mediated disease, seizure disorder, chronic cardiac disease, chronic pulmonary disease, hemoglobinopathy, coagulopathy, or malignancy.

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): NCT00115908

  Show 87 Study Locations
Sponsors and Collaborators
Human Genome Sciences Inc.
Study Director: GSK Clinical Trials GlaxoSmithKline

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Human Genome Sciences Inc.
ClinicalTrials.gov Identifier: NCT00115908     History of Changes
Other Study ID Numbers: ALFR-HC-04
First Posted: June 27, 2005    Key Record Dates
Last Update Posted: November 7, 2013
Last Verified: November 2013

Keywords provided by Human Genome Sciences Inc.:
Hepatitis C

Additional relevant MeSH terms:
Hepatitis A
Hepatitis C
Hepatitis, Chronic
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Peginterferon alfa-2a
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Molecular Mechanisms of Pharmacological Action