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

NCT ID: NCT00656006

Last Updated: 2013-08-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-11-30

Study Completion Date

2007-04-30

Brief Summary

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

Detailed Description

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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

Conditions

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Chronic Hepatitis C

Keywords

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Hepatitis C Chronic Genotype 2 or 3 Treatment naive

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Albuferon

Intervention Type DRUG

Ribavirin

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Human Genome Sciences Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Human Genome Sciences

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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University of Calgary

Calgary, Alberta, Canada

Site Status

University of Alberta

Edmonton, Alberta, Canada

Site Status

University of British Columbia

Vancouver, British Columbia, Canada

Site Status

University of Manitoba

Winnipeg, Manitoba, Canada

Site Status

University of Western Ontario

London, Ontario, Canada

Site Status

University of Saskatchewan

Saskatoon, Saskatchewan, Canada

Site Status

Countries

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Canada

Other Identifiers

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HGS1008-C1052 (ALFR-HC-06)

Identifier Type: -

Identifier Source: org_study_id