Treatment of Acute Hepatitis C Virus Infection With Pegylated Interferon in Injection Drug Users - Full Text View

Sponsor:	National Institute on Drug Abuse (NIDA)
Collaborator:	University of Washington
Information provided by:	National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:	NCT00194480

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 IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Treatment of Acute Hepatitis C Virus Infection in Injection Drug Users With Pegylated Interferon for 24 Weeks

Resource links provided by NLM:

MedlinePlus related topics: Hepatitis Hepatitis C

Drug Information available for: Interferons

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
PegInterferon: Experimental 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:	NIDA ( Jag H. Khalsa, Ph.D. )
Study ID Numbers:	NIDA-16066-1, R21 DA016066-01
Study First Received:	September 12, 2005
Last Updated:	October 24, 2008
ClinicalTrials.gov Identifier:	NCT00194480 History of Changes
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:

Anti-Infective Agents
Liver Diseases
RNA Virus Infections
Flaviviridae Infections
Antineoplastic Agents
Interferons
Hepatitis, Viral, Human
Disorders of Environmental Origin
Antiviral Agents

Pharmacologic Actions
Hepatitis
Virus Diseases
Digestive System Diseases
Mental Disorders
Therapeutic Uses
Substance-Related Disorders
Hepatitis C

ClinicalTrials.gov processed this record on November 09, 2009