Treatment of Acute Hepatitis C Virus Infection With Pegylated Interferon in Injection Drug Users
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ClinicalTrials.gov Identifier: NCT00194480 |
Recruitment Status
:
Completed
First Posted
: September 19, 2005
Last Update Posted
: January 12, 2017
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Tracking Information | ||||
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First Submitted Date ICMJE | September 12, 2005 | |||
First Posted Date ICMJE | September 19, 2005 | |||
Last Update Posted Date | January 12, 2017 | |||
Study Start Date ICMJE | April 2003 | |||
Actual Primary Completion Date | December 2006 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Sustained viral response rate in treatment group versus control (measured at Week 24) [ Time Frame: 24 weeks ] | |||
Original Primary Outcome Measures ICMJE |
Sustained viral response rate in treatment group versus control | |||
Change History | Complete list of historical versions of study NCT00194480 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
Adherence rate in the treatment group (measured at Week 24) [ Time Frame: 24 weeks ] | |||
Original Secondary Outcome Measures ICMJE |
Adherence rate in the treatment group. | |||
Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Treatment of Acute Hepatitis C Virus Infection With Pegylated Interferon in Injection Drug Users | |||
Official Title ICMJE | 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. | |||
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 Type ICMJE | Interventional | |||
Study Phase | Phase 4 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE | Drug: Pegylated Interferon
Weekly injections of pegIntereferon |
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Study Arms | Experimental: PegInterferon
Arm 1: 24 weeks of weekly injections of peginterferon Arm 2: control (no treatment)
Intervention: Drug: Pegylated Interferon |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
21 | |||
Original Enrollment ICMJE |
40 | |||
Actual Study Completion Date | June 2007 | |||
Actual Primary Completion Date | December 2006 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 15 Years and older (Child, Adult, Senior) | |||
Accepts Healthy Volunteers | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00194480 | |||
Other Study ID Numbers ICMJE | NIDA-16066-1 R21DA016066-01 ( U.S. NIH Grant/Contract ) |
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Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Jag H. Khalsa, Ph.D., NIDA | |||
Study Sponsor ICMJE | National Institute on Drug Abuse (NIDA) | |||
Collaborators ICMJE | University of Washington | |||
Investigators ICMJE |
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PRS Account | National Institute on Drug Abuse (NIDA) | |||
Verification Date | October 2008 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |