Status:
COMPLETED
Evaluation of a Multi-disciplinary Approach for the Treatment of Hepatitis C in IDUs (HI-LO Study)
Lead Sponsor:
University of British Columbia
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
Conditions:
Hepatitis C Virus Infection
Eligibility:
All Genders
19+ years
Phase:
NA
Brief Summary
Although injection drug users (IDUs) account for over 70% of new cases of HCV infection/year, there is no consensus on how to approach their medical care. In some Canadian centres, patients must be fr...
Detailed Description
We will determine the HCV infection status of potential study subjects within a cohort of 2,000 IDUs receiving care in our centres (Appendix 1). For those who carry HCV antibodies (expected n = 1800),...
Eligibility Criteria
Inclusion
- Age \> 19 years;
- Serum HCV-RNA pos;
- HCV genotype 2 or 3;
- HBsAg neg;
- serum ALT \> 1.5x upper limit normal \> 3 months;
- Illicit drug use in the past year;
- Agreement from each participant of childbearing age to practice contraception;
- Absence of other contraindications to the initiation of therapy as determined by the health care team;
- Ability to provide informed consent.
Exclusion
- Any cause for chronic liver disease other than HCV (including alcohol use \>350 g/wk);
- Pregnant or breastfeeding women;
- Active HBV infection;
- Hemolytic anemia;
- Decompensated cirrhosis or portal hypertension or PT-INR \> 1.3 or Child-Hugh class \> A;
- Active suicidal ideation, psychosis, mania or hypomania;
- Serum creatinine \> 180 µg/mL;
- Hemoglobin \< 120 g/L in men or 110 g/L in women;
- Platelets \< 90 x 109/L;
- Neutrophils \< 1.5 x 109/L;
- Active autoimmune disease;
- NYHA disease \> grade 2;
- Psoriasis requiring systemic therapy;
- Active malignancy apart from non melanoma skin cancer;
- Use of systemic immunosuppressant agents;
- Prior treatment of HCV with interferon or ribavirin;
- HIV positive with CD4 count \<300 cells/mm3 or receiving didanosine (due to interaction with ribavirin);
- Life expectancy \< 2 years.
Key Trial Info
Start Date :
June 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
370 Patients enrolled
Trial Details
Trial ID
NCT00399672
Start Date
June 1 2007
End Date
December 1 2012
Last Update
November 30 2016
Active Locations (1)
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1
Pender Community Health Centre
Vancouver, British Columbia, Canada, V6B 1R3