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| Descriptive Information Fields | |||||
| Brief Title † | Treatment of Acute Hepatitis C Virus Infection With Pegylated Interferon in Injection Drug Users | ||||
| Official Title † | Treatment of Acute Hepatitis C Virus Infection in Injection Drug Users With Pegylated Interferon for 24 Weeks | ||||
| 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. |
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| 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. |
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| Study Phase | Phase IV | ||||
| Study Type † | Interventional | ||||
| Study Design † | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study | ||||
| Primary Outcome Measure † | Sustained viral response rate in treatment group versus control (measured at Week 24) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ] | ||||
| Secondary Outcome Measure † | Adherence rate in the treatment group (measured at Week 24) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ] | ||||
| Condition † | Substance-Related Disorders Hepatitis |
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| Intervention † | Drug: Pegylated Interferon | ||||
| MEDLINE PMIDs | |||||
| Links | |||||
| Recruitment Information Fields | |||||
| Recruitment Status † | Completed | ||||
| Enrollment † | 21 | ||||
| Start Date † | April 2003 | ||||
| Completion Date | June 2007 | ||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 15 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† | |||||
| Location Countries † | United States | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00194480 | ||||
| Organization ID | NIDA-16066-1 | ||||
| Secondary IDs †† | R21 DA016066-01 | ||||
| Study Sponsor † | National Institute on Drug Abuse (NIDA) | ||||
| Collaborators †† | University of Washington | ||||
| Investigators † |
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| Information Provided By | National Institute on Drug Abuse (NIDA) | ||||
| Verification Date | October 2008 | ||||
| First Received Date † | September 12, 2005 | ||||
| Last Updated Date | October 24, 2008 | ||||