Treatment of Acute Hepatitis C Virus Infection With Pegylated Interferon in Injection Drug Users

Completed · Phase 4

Conditions studied: Substance-Related Disorders, Hepatitis

In brief

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 treating injection drug users (IDUs) with acute HCV.

Key facts

Study ID

NCT00194480

Run by

National Institute on Drug Abuse (NIDA)

People needed

21

Starts

2003-04-01

Expected to finish

2007-06-01

Last updated by the study team

2017-01-12

Who can join

Age: 15 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Harborview Medical Center, 325 Ninth Ave 1EC32 — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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