A Study of Albuferon With Ribavirin in Interferon Alfa Naive Subjects With Chronic Hepatitis C Genotype 2 or 3
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ClinicalTrials.gov Identifier: NCT00656006 |
Recruitment Status :
Completed
First Posted : April 10, 2008
Last Update Posted : August 2, 2013
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Chronic Hepatitis C | Drug: Albuferon Drug: Ribavirin | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 43 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (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 |
Study Start Date : | November 2005 |
Actual Primary Completion Date : | April 2007 |
Actual Study Completion Date : | April 2007 |

- 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.

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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00656006
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 |
Study Director: | GSK Clinical Trials | GlaxoSmithKline |
Responsible Party: | Patrick Cronin, Human Genome Sciences |
ClinicalTrials.gov Identifier: | NCT00656006 |
Other Study ID Numbers: |
HGS1008-C1052 (ALFR-HC-06) |
First Posted: | April 10, 2008 Key Record Dates |
Last Update Posted: | August 2, 2013 |
Last Verified: | August 2013 |
Hepatitis C Chronic Genotype 2 or 3 Treatment naive |
Hepatitis A Hepatitis C Hepatitis C, Chronic Hepatitis Hepatitis, Chronic Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Infections Enterovirus Infections |
Picornaviridae Infections RNA Virus Infections Blood-Borne Infections Communicable Diseases Flaviviridae Infections Ribavirin Antimetabolites Molecular Mechanisms of Pharmacological Action Antiviral Agents Anti-Infective Agents |