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

This study has been completed.
Sponsor:
Collaborator:
University of Washington
Information provided by:
National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:
NCT00194480
First received: September 12, 2005
Last updated: October 24, 2008
Last verified: October 2008

September 12, 2005
October 24, 2008
April 2003
December 2006   (final data collection date for 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 ]
Sustained viral response rate in treatment group versus control
Complete list of historical versions of study NCT00194480 on ClinicalTrials.gov Archive Site
Adherence rate in the treatment group (measured at Week 24) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Adherence rate in the treatment group.
Not Provided
Not Provided
 
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

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Substance-Related Disorders
  • Hepatitis
Drug: Pegylated Interferon
Weekly injections of pegIntereferon
Experimental: PegInterferon
Arm 1: 24 weeks of weekly injections of peginterferon Arm 2: control (no treatment)
Intervention: Drug: Pegylated Interferon
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
21
June 2007
December 2006   (final data collection date for primary outcome measure)

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
Both
15 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00194480
NIDA-16066-1, R21 DA016066-01
Yes
Jag H. Khalsa, Ph.D., NIDA
National Institute on Drug Abuse (NIDA)
University of Washington
Principal Investigator: Chia Wang, MD, MS University of Washington
National Institute on Drug Abuse (NIDA)
October 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP