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

Sponsor:	Human Genome Sciences
Information provided by:	Human Genome Sciences
ClinicalTrials.gov Identifier:	NCT00656006

Purpose

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

Condition	Intervention	Phase
Chronic Hepatitis C	Drug: Albuferon Drug: Ribavirin	Phase II

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 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

Resource links provided by NLM:

MedlinePlus related topics: Hepatitis Hepatitis A Hepatitis C

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

U.S. FDA Resources

Further study details as provided by Human Genome Sciences:

Primary Outcome Measures:

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

Enrollment:	43
Study Start Date:	November 2005
Study Completion Date:	April 2007
Primary Completion Date:	April 2007 (Final data collection date for primary outcome measure)

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

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00656006

Locations

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

Investigators

Study Director:

Dan Odenheimer, Ph.D

Human Genome Sciences, Inc.

More Information

No publications provided

Responsible Party:	Patrick Cronin, Human Genome Sciences
ClinicalTrials.gov Identifier:	NCT00656006 History of Changes
Other Study ID Numbers:	HGS1008-C1052 (ALFR-HC-06)
Study First Received:	December 20, 2005
Last Updated:	May 11, 2011
Health Authority:	Canada: Health Canada

Keywords provided by Human Genome Sciences:

Hepatitis C
Chronic
Genotype 2 or 3
Treatment naive

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
Interferon-alpha
Interferon Alfa-2a

Interferons
Ribavirin
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012