A Study of Albuferon With Ribavirin in… | Clinical Trial

Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Calgary, Calgary, Alberta, Canada

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Albuferon

Drug

Ribavirin

Drug

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Human Genome Sciences Inc.

Industry

Registry information

Official study 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

Important dates

Study start: 2005
Primary completion: 2007
Study completion: 2007
First posted: Apr 10, 2008
Registry last updated: Aug 2, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed