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

NCT00656006 | Completed Phase 2 DMC

• 1 other identifier: HGS1008-C1052 (ALFR-HC-06)
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 6

Brief Summary

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

Conditions

Chronic Hepatitis C

Keywords

Hepatitis C; Chronic; Genotype 2 or 3; Treatment naive

Outcome Measures

Primary Outcomes (2)

• 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.

Interventions

Albuferon DRUG

Ribavirin DRUG

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Human Genome Sciences Inc.: lead

Study Sites (6)

University of Calgary

Calgary, Alberta, T2N 4N1, Canada

Location

University of Alberta

Edmonton, Alberta, T6G 2X8, Canada

Location

University of British Columbia

Vancouver, British Columbia, V5Z 3P1, Canada

Location

University of Manitoba

Winnipeg, Manitoba, R3E 2P4, Canada

Location

University of Western Ontario

London, Ontario, N6A 5A5, Canada

Location

University of Saskatchewan

Saskatoon, Saskatchewan, S7N 0W8, Canada

Location

MeSH Terms

Conditions

Hepatitis C, Chronic; Hepatitis C; Bronchiolitis Obliterans Syndrome

Interventions

albuferon; Ribavirin

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases

Intervention Hierarchy (Ancestors)

Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 20, 2005
• First Posted: April 10, 2008
• Study Start: November 1, 2005
• Primary Completion: April 1, 2007
• Study Completion: April 1, 2007
• Last Updated: August 2, 2013

Record last verified: 2013-08

Locations

CA (6)