Status:
COMPLETED
Treatment of Acute Hepatitis C Virus Infection With Pegylated Interferon in Injection Drug Users
Lead Sponsor:
National Institute on Drug Abuse (NIDA)
Collaborating Sponsors:
University of Washington
Conditions:
Substance-Related Disorders
Hepatitis
Eligibility:
All Genders
15+ years
Phase:
PHASE4
Brief Summary
Injection drug use accounts for transmission of a high proportion of Hepatitis C Virus (HCV) infections. The purpose of this trial is to investigate the effectiveness of pegylated interferon in treati...
Detailed Description
IDUs are at high risk for developing HCV. Pegylated interferon is a man-made form of interferon, a chemical naturally produced by the body that works to fight viruses. Interferon helps to stop HCV fro...
Eligibility Criteria
Inclusion
- Documented HCV antibody seroconversion within the 12 months prior to study entry
- Serum positive for HCV
- Meets hematologic, biochemical, and serologic criteria at entry visit
- Thyroid stimulating hormone within normal limits
- Hepatitis B surface antigen negative
- Reads at an eighth grade reading level
- Willing to use adequate contraception for the duration of the study
- Plans to remain in the study area for 12 months
Exclusion
- Positive test for Hepatitis A antibodies, Hepatitis B antibodies, or HIV antibodies
- Suspected hypersensitivity to pegylated interferon
- Liver disease
- Hemoglobinopathies
- Immune mediated disease
- Significant cardiac or pulmonary disease
- Uncontrolled seizure disorder
- Renal insufficiency with serum creatinine levels greater than 11.5 mb/ml or less than 60 mb/ml
- History of thyroid disease
- Active gout
- Any medical condition requiring or likely to require steroids during the course of study
- Untreated severe psychiatric disorder, as determined by study psychiatrist
- Any condition, which in the opinion of the investigator, would preclude successful completion of the study
- Pregnant or breastfeeding
Key Trial Info
Start Date :
April 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2007
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT00194480
Start Date
April 1 2003
End Date
June 1 2007
Last Update
January 12 2017
Active Locations (1)
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1
Harborview Medical Center, 325 Ninth Ave 1EC32
Seattle, Washington, United States, 98104