A Study of Albuferon With Ribavirin in Interferon Treatment Experienced Subjects With Chronic Hepatitis C
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00097435 |
Recruitment Status :
Completed
First Posted : November 24, 2004
Last Update Posted : August 2, 2013
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hepatitis C | Drug: Albuferon Drug: Ribavirin | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 115 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Multi-Center, Randomized, Open-Label Study to Evaluate the Safety, Tolerability, and Efficacy of Albuferon (Recombinant Human Albumin-Interferon Alfa Fusion Protein) in Combination With Ribavirin in Interferon Treatment Experienced Subjects With Chronic Hepatitis C |
Study Start Date : | October 2004 |
Actual Primary Completion Date : | August 2007 |
Actual Study Completion Date : | August 2007 |

- The major safety endpoints are the common side effects of IFNa therapy including flu-like symptoms, depression, and hematologic abnormalities.
- Sustained virologic response (SVR), defined as undetectable virus at 24 weeks after the end of therapy. The primary efficacy assessment is HCV RNA level.

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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 |
Major Inclusion Criteria:
- Have a clinical diagnosis of chronic HEP C established on the basis of detectable viral load, as measured by a serum HCV RNA test during the screening period.
- Have previously failed to respond to treatment with any interferon alfa (IFNa) product
- Have compensated liver disease with the following minimum criteria: white blood cell count > 3,000/mm3, absolute neutrophil count (ANC) > 2,000/mm3, platelets > 125,000/mm3, and hemoglobin (Hb) > 13 g/dL for males or > 12 g/dL for females.
Major Exclusion Criteria:
- Evidence of decompensated cirrhosis or portal hypertension.
- 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): NCT00097435
United States, Arizona | |
Mayo Clinic | |
Phoenix, Arizona, United States, 85054 | |
United States, Florida | |
University of Florida CRC | |
Gainesville, Florida, United States, 32610 | |
University of Florida at Jacksonville | |
Jacksonville, Florida, United States, 32209 | |
Mayo Clinic Jacksonville | |
Jacksonville, Florida, United States, 32216 | |
United States, Maryland | |
Johns Hopkins University | |
Baltimore, Maryland, United States, 21287 | |
United States, Minnesota | |
Mayo Clinic Rochester | |
Rochester, Minnesota, United States, 55905 | |
United States, North Carolina | |
Duke University | |
Durham, North Carolina, United States, 27710 | |
United States, Virginia | |
Metropolitan Research | |
Fairfax, Virginia, United States, 22031 |
Study Director: | GSK Clinical Trials | GlaxoSmithKline |
Responsible Party: | Human Genome Sciences Inc. |
ClinicalTrials.gov Identifier: | NCT00097435 |
Other Study ID Numbers: |
Clinical Protocol ALFR-HC-05 |
First Posted: | November 24, 2004 Key Record Dates |
Last Update Posted: | August 2, 2013 |
Last Verified: | August 2013 |
Hepatitis A Hepatitis C Hepatitis C, Chronic Hepatitis 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 Hepatitis, Chronic Ribavirin Antimetabolites Molecular Mechanisms of Pharmacological Action Antiviral Agents Anti-Infective Agents |