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A Study of Albuferon With Ribavirin in Interferon Treatment Experienced Subjects With Chronic Hepatitis C

Information source: Human Genome Sciences Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hepatitis C

Intervention: Albuferon (Drug); Ribavirin (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Human Genome Sciences Inc.

Official(s) and/or principal investigator(s):
GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline

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.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: The major safety endpoints are the common side effects of IFNa therapy including flu-like symptoms, depression, and hematologic abnormalities.

Secondary outcome: Sustained virologic response (SVR), defined as undetectable virus at 24 weeks after the end of therapy. The primary efficacy assessment is HCV RNA level.

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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

Locations and Contacts

Mayo Clinic, Phoenix, Arizona 85054, United States

University of Florida CRC, Gainesville, Florida 32610, United States

Mayo Clinic Jacksonville, Jacksonville, Florida 32216, United States

University of Florida at Jacksonville, Jacksonville, Florida 32209, 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

Additional Information

Starting date: October 2004
Last updated: August 1, 2013

Page last updated: August 23, 2015

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