NCT00194480

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

Treatment of Acute Hepatitis C Virus Infection in Injection Drug Users With Pegylated Interferon for 24 Weeks

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: National Institute on Drug Abuse (NIDA) · NIH
• Sex: All
• Age: 15 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Pegylated Interferon	Weekly injections of pegIntereferon

Timeline

• Start date: 2003-04-01
• Primary completion: 2006-12-01
• Completion: 2007-06-01
• First posted: 2005-09-19
• Last updated: 2017-01-12

Locations

1 site across 1 country: United States