A Study of Albuferon With Ribavirin in Interferon Treatment Experienced Subjects With Chronic Hepatitis C
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
1 other identifier
interventional
115
1 country
8
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Oct 2004
Typical duration for phase_2
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2004
CompletedFirst Submitted
Initial submission to the registry
November 23, 2004
CompletedFirst Posted
Study publicly available on registry
November 24, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2007
CompletedAugust 2, 2013
August 1, 2013
2.8 years
November 23, 2004
August 1, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
The major safety endpoints are the common side effects of IFNa therapy including flu-like symptoms, depression, and hematologic abnormalities.
Secondary Outcomes (1)
Sustained virologic response (SVR), defined as undetectable virus at 24 weeks after the end of therapy. The primary efficacy assessment is HCV RNA level.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
Mayo Clinic
Phoenix, Arizona, 85054, United States
University of Florida CRC
Gainesville, Florida, 32610, United States
University of Florida at Jacksonville
Jacksonville, Florida, 32209, United States
Mayo Clinic Jacksonville
Jacksonville, Florida, 32216, United States
Johns Hopkins University
Baltimore, Maryland, 21287, United States
Mayo Clinic Rochester
Rochester, Minnesota, 55905, United States
Duke University
Durham, North Carolina, 27710, United States
Metropolitan Research
Fairfax, Virginia, 22031, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 23, 2004
First Posted
November 24, 2004
Study Start
October 1, 2004
Primary Completion
August 1, 2007
Study Completion
August 1, 2007
Last Updated
August 2, 2013
Record last verified: 2013-08