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

Tracking Information
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; (submitted: October 24, 2008)	Sustained viral response rate in treatment group versus control (measured at Week 24) [ Time Frame: 24 weeks ]
Original Primary Outcome Measures ICMJE; (submitted: September 12, 2005)	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; (submitted: October 24, 2008)	Adherence rate in the treatment group (measured at Week 24) [ Time Frame: 24 weeks ]
Original Secondary Outcome Measures ICMJE; (submitted: September 12, 2005)	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.
Study Type ICMJE	Interventional
Study Phase	Phase 4
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition ICMJE	Substance-Related Disorders; Hepatitis
Intervention ICMJE	Drug: Pegylated Interferon; Weekly injections of pegIntereferon
Study Arms	Experimental: PegInterferon; Arm 1: 24 weeks of weekly injections of peginterferon Arm 2: control (no treatment); Intervention: Drug: Pegylated Interferon
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: October 24, 2008)	21
Original Enrollment ICMJE; (submitted: September 12, 2005)	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: 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
Sex/Gender	Sexes Eligible for Study: All
Ages	15 Years and older (Child, Adult, Older Adult)
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 )
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	Principal Investigator: Chia Wang, MD, MS University of Washington
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