ACTRN12608000400369
Recruiting
Phase 4
A single-arm, open-label, pilot study evaluating the efficacy and safety of directly observed peginterferon alfa-2a with ribavirin in conjunction with a peer counsellor in patients actively using injecting drugs who have chronic hepatitis C and attend a drug and alcohol centre.
Dr Joe Sasadeusz0 sites50 target enrollmentAugust 8, 2008
ConditionsImpact of standard pharmacotherapy treatment of chronic Hepatitis C virus (HCV) infection on: (i) quality of life, (ii) mental health status, (iii) injecting drug behaviours, and (iv) opioid pharmacotherapy use in active injecting drug users (IDUs).Side effects related to chronic Hepatitis C virus (HCV) infection and treatment in active injecting drug users (IDUs).Factors affecting compliance of active injecting drug users (IDUs) for standard pharmacotherapy treatment of chronic Hepatitis C virus (HCV) infection.Chronic hepatitis C virus (HCV) infection.Public Health - Other public healthMental Health - AddictionInfection - Other infectious diseases
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Impact of standard pharmacotherapy treatment of chronic Hepatitis C virus (HCV) infection on: (i) quality of life, (ii) mental health status, (iii) injecting drug behaviours, and (iv) opioid pharmacotherapy use in active injecting drug users (IDUs).
- Sponsor
- Dr Joe Sasadeusz
- Enrollment
- 50
- Status
- Recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Informed consent
- •Age \= 18 years
- •Serologic evidence of chronic hepatitis C infection by an anti\-HCV antibody test and positive HCV PCR (Polymerase Chain Reaction) for \> 6 months
- •Detectable serum HCV\-RNA (ribonucleic acid) at screening
- •Compensated liver disease (Child\-Pugh Grade A clinical classification)
- •Negative urine or blood pregnancy test (for women of childbearing potential) documented within the 24\-hour period prior to the first dose of study drug
- •All fertile males and females and their partners must be using effective contraception during treatment and during the 6 months after treatment end
- •Have had an episode of injecting drug use within 4 weeks of screening
- •Drinking 2 standard drinks or less of alcohol per day ( binge drinking will be allowed as long as it does not exceed 6 standard drinks for males and 4 standard drinks for females less than every 2 weeks)
Exclusion Criteria
- •Frequency of injecting drug use of daily or greater
- •Females who are pregnant, breastfeeding or planning a pregnancy
- •Inability or unwillingness to provide informed consent or abide by the requirements of the study protocol
- •Patients unwilling to use an acceptable method of birth control (defined as surgical sterility, intrauterine device, oral contraception, diaphragm or condom in association with a spermicide)
- •Patients previously treated with interferon or ribavirin
- •Evidence of excessive substance abuse as judged by the investigator
- •Therapy with any systemic anti\-viral, anti\-neoplastic or immunomodulatory treatment (including supraphysiologic doses of steroids and radiation) \<\=6 months prior to the first dose of study drug
- •Any investigational drug \<\=4 weeks or 5 half lives, whichever is longer, prior to the first dose of study drug
- •Positive test at screening for anti\-HAV IgM Ab, HBsAg, anti\-HBc IgM Ab, anti\-HIV Ab
- •History or other evidence of a medical condition associated with chronic liver disease other than HCV (eg. hemochromatosis, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease)
Outcomes
Primary Outcomes
Not specified
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