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| Sponsor: | National Institute on Drug Abuse (NIDA) |
|---|---|
| Collaborator: |
University of Washington |
| Information provided by: | National Institute on Drug Abuse (NIDA) |
| ClinicalTrials.gov Identifier: | NCT00194480 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Substance-Related Disorders Hepatitis |
Drug: Pegylated Interferon |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
| Official Title: | Treatment of Acute Hepatitis C Virus Infection in Injection Drug Users With Pegylated Interferon for 24 Weeks |
| Enrollment: | 21 |
| Study Start Date: | April 2003 |
| Study Completion Date: | June 2007 |
| Primary Completion Date: | December 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
PegInterferon: Experimental
Arm 1: 24 weeks of weekly injections of peginterferon Arm 2: control (no treatment)
|
Drug: Pegylated Interferon
Weekly injections of pegIntereferon
|
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.
Eligibility| Ages Eligible for Study: | 15 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Washington | |
| Harborview Medical Center, 325 Ninth Ave 1EC32 | |
| Seattle, Washington, United States, 98104 | |
| Principal Investigator: | Chia Wang, MD, MS | University of Washington |
More Information
| Responsible Party: | NIDA ( Jag H. Khalsa, Ph.D. ) |
| Study ID Numbers: | NIDA-16066-1, R21 DA016066-01 |
| Study First Received: | September 12, 2005 |
| Last Updated: | October 24, 2008 |
| ClinicalTrials.gov Identifier: | NCT00194480 History of Changes |
| Health Authority: | United States: Federal Government |
|
Hepatitis C, peg-Interferon, drug abuse |
|
Anti-Infective Agents Liver Diseases RNA Virus Infections Flaviviridae Infections Antineoplastic Agents Interferons Hepatitis, Viral, Human Disorders of Environmental Origin Antiviral Agents |
Pharmacologic Actions Hepatitis Virus Diseases Digestive System Diseases Mental Disorders Therapeutic Uses Substance-Related Disorders Hepatitis C |