Back to resultsA Study of Albuferon With Ribavirin in Interferon Treatment Experienced Subjects With Chronic Hepatitis C
Primary Purpose
Hepatitis C
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Albuferon
Ribavirin
Sponsored by
About this trial
This is an interventional treatment trial for Hepatitis C
Eligibility 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
Sites / Locations
- Mayo Clinic
- University of Florida CRC
- University of Florida at Jacksonville
- Mayo Clinic Jacksonville
- Johns Hopkins University
- Mayo Clinic Rochester
- Duke University
- Metropolitan Research
Outcomes
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.
Full Information
NCT ID
NCT00097435
First Posted
November 23, 2004
Last Updated
August 1, 2013
Sponsor
Human Genome Sciences Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00097435
Brief Title
A Study of Albuferon With Ribavirin in Interferon Treatment Experienced Subjects With Chronic Hepatitis C
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 Type
Interventional
2. Study Status
Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
October 2004 (undefined)
Primary Completion Date
August 2007 (Actual)
Study Completion Date
August 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Human Genome Sciences Inc.
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
115 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Albuferon
Intervention Type
Drug
Intervention Name(s)
Ribavirin
Primary Outcome Measure Information:
Title
The major safety endpoints are the common side effects of IFNa therapy including flu-like symptoms, depression, and hematologic abnormalities.
Secondary Outcome Measure Information:
Title
Sustained virologic response (SVR), defined as undetectable virus at 24 weeks after the end of therapy. The primary efficacy assessment is HCV RNA level.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
Mayo Clinic
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85054
Country
United States
Facility Name
University of Florida CRC
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
University of Florida at Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
Facility Name
Mayo Clinic Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Mayo Clinic Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Duke University
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Metropolitan Research
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study of Albuferon With Ribavirin in Interferon Treatment Experienced Subjects With Chronic Hepatitis C
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