A Study of Albuferon With Ribavirin in Interferon Treatment Experienced Subjects With Chronic Hepatitis C
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| ClinicalTrials.gov Identifier: NCT00097435 |
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Recruitment Status
:
Completed
First Posted
: November 24, 2004
Last Update Posted
: August 2, 2013
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Sponsor:
Human Genome Sciences Inc.
Information provided by (Responsible Party):
Human Genome Sciences Inc.
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Brief Summary:
This is a Phase 2, multi-center, randomized, open-label study to evaluate the safety, tolerability, and efficacy of Albuferon in subjects with hepatitis C (HEP C) who failed to respond to previous interferon alfa therapy.
| 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 |
Primary Outcome Measures
:
- The major safety endpoints are the common side effects of IFNa therapy including flu-like symptoms, depression, and hematologic abnormalities.
Secondary Outcome Measures
:
- 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) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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
Information from the National Library of Medicine
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
Locations
| 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 | |
Sponsors and Collaborators
Human Genome Sciences Inc.
Investigators
| Study Director: | GSK Clinical Trials | GlaxoSmithKline |
| Responsible Party: | Human Genome Sciences Inc. |
| ClinicalTrials.gov Identifier: | NCT00097435 History of Changes |
| 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 |
Additional relevant MeSH terms:
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Hepatitis Hepatitis A Hepatitis C Hepatitis, Chronic Hepatitis C, Chronic Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Enterovirus Infections |
Picornaviridae Infections RNA Virus Infections Flaviviridae Infections Interferons Ribavirin Antineoplastic Agents Antiviral Agents Anti-Infective Agents Antimetabolites Molecular Mechanisms of Pharmacological Action |