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

Sponsored by:	Human Genome Sciences
Information provided by:	Human Genome Sciences
ClinicalTrials.gov Identifier:	NCT00115908

Purpose

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	Intervention	Phase
Hepatitis C, Chronic	Drug: Albuferon/ribavirin Drug: PEG-IFNalfa2a/ribavirin	Phase II

MedlinePlus related topics: Hepatitis Hepatitis C

Drug Information available for: Ribavirin Interferon alfa-n1 Interferon alfa-2a Interferons Albinterferon Alfa-2B

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Human Genome Sciences:

Primary Outcome Measures:

Sustained virologic response (SVR), defined as undetectable
HCV RNA at 24 weeks after the end of therapy

Secondary Outcome Measures:

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

Estimated Enrollment:	460
Study Start Date:	May 2005

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00115908

Show 87 Study Locations

Sponsors and Collaborators

Human Genome Sciences

Investigators

Study Director:

Mani Subramanian, M.D., Ph.D

Human Genome Sciences

More Information

Publications indexed to this study:

Zeuzem S, Yoshida EM, Benhamou Y, Pianko S, Bain VG, Shouval D, Flisiak R, Rehak V, Grigorescu M, Kaita K, Cronin PW, Pulkstenis E, Subramanian GM, McHutchison JG. Albinterferon alfa-2b dosed every two or four weeks in interferon-naïve patients with genotype 1 chronic hepatitis C. Hepatology. 2008 Aug;48(2):407-17.

Study ID Numbers:	ALFR-HC-04
Study First Received:	June 26, 2005
Last Updated:	October 16, 2007
ClinicalTrials.gov Identifier:	NCT00115908
Health Authority:	Israel: Israeli Health Ministry Pharmaceutical Administration; Australia: Department of Health and Ageing Therapeutic Goods Administration; Canada: Health Canada; Czech Republic: State Institute for Drug Control; France: Afssaps - French Health Products Safety Agency; Germany: Federal Institute for Drugs and Medical Devices; Poland: Ministry of Health; Romania: State Institute for Drug Control

Keywords provided by Human Genome Sciences:

Hepatitis C

Study placed in the following topic categories:

Interferon-alpha
Virus Diseases
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Chronic

Interferons
Ribavirin
Hepatitis, Viral, Human
Hepatitis C
Interferon Alfa-2a
Hepatitis C, Chronic

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
RNA Virus Infections
Molecular Mechanisms of Pharmacological Action
Flaviviridae Infections

Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009