A Study of Albuferon With Ribavirin in Interferon Treatment Experienced Subjects With Chronic Hepatitis C
This study has been completed.
Sponsor:
Human Genome Sciences Inc.
Information provided by (Responsible Party):
Human Genome Sciences Inc.
ClinicalTrials.gov Identifier:
NCT00097435
First received: November 23, 2004
Last updated: August 1, 2013
Last verified: August 2013
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Hepatitis C |
Drug: Albuferon Drug: Ribavirin |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: 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 |
Resource links provided by NLM:
Further study details as provided by Human Genome Sciences Inc.:
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.
| Enrollment: | 115 |
| Study Start Date: | October 2004 |
| Study Completion Date: | August 2007 |
| Primary Completion Date: | August 2007 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
| Genders Eligible for Study: | Both |
| 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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00097435
Please refer to this study by its ClinicalTrials.gov identifier: 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 |
More Information
| Responsible Party: | Human Genome Sciences Inc. |
| ClinicalTrials.gov Identifier: | NCT00097435 History of Changes |
| Other Study ID Numbers: | Clinical Protocol ALFR-HC-05 |
| Study First Received: | November 23, 2004 |
| Last Updated: | August 1, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Hepatitis C Hepatitis Hepatitis A Hepatitis, Chronic Hepatitis C, Chronic Hepatitis, Viral, Human Virus Diseases Flaviviridae Infections RNA Virus Infections Liver Diseases |
Digestive System Diseases Enterovirus Infections Picornaviridae Infections Interferons Ribavirin Antineoplastic Agents Antiviral Agents Anti-Infective Agents Antimetabolites Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on September 26, 2016