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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00194480
Recruitment Status : Completed
First Posted : September 19, 2005
Last Update Posted : January 12, 2017
University of Washington
Information provided by:
National Institute on Drug Abuse (NIDA)

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.

Condition or disease Intervention/treatment Phase
Substance-Related Disorders Hepatitis Drug: Pegylated Interferon Phase 4

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 : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Acute Hepatitis C Virus Infection in Injection Drug Users With Pegylated Interferon for 24 Weeks
Study Start Date : April 2003
Actual Primary Completion Date : December 2006
Actual Study Completion Date : June 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Interferon

Arm Intervention/treatment
Experimental: PegInterferon
Arm 1: 24 weeks of weekly injections of peginterferon Arm 2: control (no treatment)
Drug: Pegylated Interferon
Weekly injections of pegIntereferon

Primary Outcome Measures :
  1. Sustained viral response rate in treatment group versus control (measured at Week 24) [ Time Frame: 24 weeks ]

Secondary Outcome Measures :
  1. Adherence rate in the treatment group (measured at Week 24) [ Time Frame: 24 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00194480

United States, Washington
Harborview Medical Center, 325 Ninth Ave 1EC32
Seattle, Washington, United States, 98104
Sponsors and Collaborators
National Institute on Drug Abuse (NIDA)
University of Washington
Principal Investigator: Chia Wang, MD, MS University of Washington

Responsible Party: Jag H. Khalsa, Ph.D., NIDA Identifier: NCT00194480     History of Changes
Other Study ID Numbers: NIDA-16066-1
R21DA016066-01 ( U.S. NIH Grant/Contract )
First Posted: September 19, 2005    Key Record Dates
Last Update Posted: January 12, 2017
Last Verified: October 2008

Keywords provided by National Institute on Drug Abuse (NIDA):
Hepatitis C, peg-Interferon, drug abuse

Additional relevant MeSH terms:
Hepatitis A
Hepatitis C
Virus Diseases
Substance-Related Disorders
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Chemically-Induced Disorders
Mental Disorders
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents