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

Substance-Related Disorders Clinical Trial

Official title:

Treatment of Acute Hepatitis C Virus Infection in Injection Drug Users With Pegylated Interferon for 24 Weeks

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00194480
• Other study ID #: NIDA-16066-1
• Secondary ID: R21DA016066-01
• Status: Completed
• Phase: Phase 4
• First received: September 12, 2005
• Last updated: January 11, 2017
• Start date: April 2003
• Est. completion date: June 2007

Study information

• Verified date: October 2008
• Source: National Institute on Drug Abuse (NIDA)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: June 2007
• Est. primary completion date: December 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Substance-Related Disorders
• Virus Diseases

Intervention

Drug:
• Pegylated Interferon
Weekly injections of pegIntereferon

Locations

Country	Name	City	State
United States	Harborview Medical Center, 325 Ninth Ave 1EC32	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
National Institute on Drug Abuse (NIDA)	University of Washington

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sustained viral response rate in treatment group versus control (measured at Week 24)		24 weeks	No
Secondary	Adherence rate in the treatment group (measured at Week 24)		24 weeks	No