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

Primary Purpose

Substance-Related Disorders, Hepatitis

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Pegylated Interferon
Sponsored by
National Institute on Drug Abuse (NIDA)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Substance-Related Disorders focused on measuring Hepatitis C, peg-Interferon, drug abuse

Eligibility Criteria

15 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Harborview Medical Center, 325 Ninth Ave 1EC32

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PegInterferon

Arm Description

Arm 1: 24 weeks of weekly injections of peginterferon Arm 2: control (no treatment)

Outcomes

Primary Outcome Measures

Sustained viral response rate in treatment group versus control (measured at Week 24)

Secondary Outcome Measures

Adherence rate in the treatment group (measured at Week 24)

Full Information

First Posted
September 12, 2005
Last Updated
January 11, 2017
Sponsor
National Institute on Drug Abuse (NIDA)
Collaborators
University of Washington
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1. Study Identification

Unique Protocol Identification Number
NCT00194480
Brief Title
Treatment of Acute Hepatitis C Virus Infection With Pegylated Interferon in Injection Drug Users
Official Title
Treatment of Acute Hepatitis C Virus Infection in Injection Drug Users With Pegylated Interferon for 24 Weeks
Study Type
Interventional

2. Study Status

Record Verification Date
October 2008
Overall Recruitment Status
Completed
Study Start Date
April 2003 (undefined)
Primary Completion Date
December 2006 (Actual)
Study Completion Date
June 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute on Drug Abuse (NIDA)
Collaborators
University of Washington

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance-Related Disorders, Hepatitis
Keywords
Hepatitis C, peg-Interferon, drug abuse

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PegInterferon
Arm Type
Experimental
Arm Description
Arm 1: 24 weeks of weekly injections of peginterferon Arm 2: control (no treatment)
Intervention Type
Drug
Intervention Name(s)
Pegylated Interferon
Intervention Description
Weekly injections of pegIntereferon
Primary Outcome Measure Information:
Title
Sustained viral response rate in treatment group versus control (measured at Week 24)
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Adherence rate in the treatment group (measured at Week 24)
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chia Wang, MD, MS
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
Harborview Medical Center, 325 Ninth Ave 1EC32
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States

12. IPD Sharing Statement

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

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