Treatment of Acute Hepatitis C Virus Infection With Pegylated Interferon in Injection Drug Users
2 other identifiers
interventional
21
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Apr 2003
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2003
CompletedFirst Submitted
Initial submission to the registry
September 12, 2005
CompletedFirst Posted
Study publicly available on registry
September 19, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2007
CompletedJanuary 12, 2017
October 1, 2008
3.7 years
September 12, 2005
January 11, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Sustained viral response rate in treatment group versus control (measured at Week 24)
24 weeks
Secondary Outcomes (1)
Adherence rate in the treatment group (measured at Week 24)
24 weeks
Study Arms (1)
PegInterferon
EXPERIMENTALArm 1: 24 weeks of weekly injections of peginterferon Arm 2: control (no treatment)
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- National Institute on Drug Abuse (NIDA)lead
- University of Washingtoncollaborator
Study Sites (1)
Harborview Medical Center, 325 Ninth Ave 1EC32
Seattle, Washington, 98104, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Chia Wang, MD, MS
University of Washington
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
Study Record Dates
First Submitted
September 12, 2005
First Posted
September 19, 2005
Study Start
April 1, 2003
Primary Completion
December 1, 2006
Study Completion
June 1, 2007
Last Updated
January 12, 2017
Record last verified: 2008-10