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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
History of Changes
  Purpose

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 Intervention Phase
Substance-Related Disorders
Hepatitis
 Drug: Pegylated Interferon
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Treatment of Acute Hepatitis C Virus Infection in Injection Drug Users With Pegylated Interferon for 24 Weeks

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:
  • Sustained viral response rate in treatment group versus control (measured at Week 24) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adherence rate in the treatment group (measured at Week 24) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Enrollment: 21
Study Start Date: April 2003
Study Completion Date: June 2007
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PegInterferon
Arm 1: 24 weeks of weekly injections of peginterferon Arm 2: control (no treatment)
 Drug: Pegylated Interferon
Weekly injections of pegIntereferon

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.

  Eligibility

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00194480

Locations
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
Investigators
Principal Investigator: Chia Wang, MD, MS University of Washington
  More Information

No publications provided

Responsible Party: Jag H. Khalsa, Ph.D., NIDA
ClinicalTrials.gov Identifier: NCT00194480     History of Changes
Other Study ID Numbers: NIDA-16066-1, R21 DA016066-01
Study First Received: September 12, 2005
Last Updated: October 24, 2008
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Hepatitis
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
Mental Disorders
Interferons
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on May 16, 2013