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

NCT ID: NCT00194480

Last Updated: 2017-01-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-04-30
• Study Completion Date: 2007-06-30

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 treating injection drug users (IDUs) with acute HCV.

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 from replicating, and helps the immune system to kill HCV. The purpose of this trial is to determine the effectiveness of pegylated interferon in IDUs with HCV.

This trial will last 24 weeks. Participants will be randomly assigned to one of two groups. Group 1 will receive pegylated interferon while group 2 will receive an active control. Injection with either pegylated interferon or control will occur weekly. During each injection visit, participants will be asked about adverse events, including common side effects to interferon such as injection site reactions, headache, myalgias, arthralgias, insomnia, and hair loss. At Weeks 2, 4, and then every 4 weeks thereafter, participants will complete depression self-reports. Laboratory assessments will occur at Week 2, and then on a monthly basis for the remainder of the study. Follow-up assessments will occur every 4 weeks after Week 24.

Conditions

Substance-Related Disorders; Hepatitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PegInterferon

Arm 1: 24 weeks of weekly injections of peginterferon Arm 2: control (no treatment)

Group Type: EXPERIMENTAL

Pegylated Interferon

Intervention Type: DRUG

Weekly injections of pegIntereferon

Interventions

Pegylated Interferon

Weekly injections of pegIntereferon

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

• 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

• Minimum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Washington

OTHER

Sponsor Role: collaborator

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: lead

Responsible Party

NIDA

Principal Investigators

Chia Wang, MD, MS

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

Harborview Medical Center, 325 Ninth Ave 1EC32

Seattle, Washington, United States

Countries

United States

Other Identifiers

R21DA016066-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NIDA-16066-1

Identifier Type: -

Identifier Source: org_study_id