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.

Phase 4

Recruiting

• 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).; 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 health; Mental Health - Addiction; Infection - Other infectious diseases

• Registration Number: ACTRN12608000400369
• Lead Sponsor: Dr Joe Sasadeusz

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-08-08
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 50

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)

History or other evidence of bleeding from oesophageal varices or other conditions consistent with decompensated liver disease as evidenced by Child’s Pugh score B or C

Neutrophil count <1500 cells/mm3 or platelet count <75,000 cells/mm3 at screening

Serum creatinine level >1.5 times the upper limit of normal at screening

History of severe psychiatric disease (defined as schizophrenia, active bipolar disorder, severe anorexia, serious or multiple episodes of self harm, currently high or moderate suicide risk, current major depressive episode or current psychosis)

History of a severe seizure disorder or current anticonvulsant use

History of immunologically-mediated disease, chronic pulmonary disease associated with functional limitation, severe cardiac disease, major organ transplantation or other evidence of severe illness, malignancy, or any other conditions which would make the patient, in the opinion of the investigator, unsuitable for the study

History of thyroid disease poorly controlled on prescribed medications, elevated thyroid stimulating hormone (TSH) concentrations with elevation of antibodies to thyroid peroxidase and any clinical manifestations of thyroid disease

Evidence of severe retinopathy (e.g. CMV retinitis, macular degeneration)

Hgb <12 g/dL in women or <13 g/dL in men at screening

Any patient with an increased baseline risk for anaemia (e.g. thalassemia, spherocytosis, history of gastrointestinal (GI) bleeding, etc) or for whom anaemia would be medically problematic

Patients with documented or presumed coronary artery disease or cerebrovascular disease should not be enrolled if, in the judgment of the investigator, an acute decrease in haemoglobin by up to 4 g/dL (as may be seen with ribavirin therapy) would not be well-tolerated

Other significant comorbidity or contraindication to therapy of study participation as determined by investigator

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Therapy compliance as measured by the proportion of participants who comply with the treatment regimen of directly observed therapy by attending at least 80% of treatment visits.[At the end of year 3 when all participant follow-up visits are complete.];Therapy compliance as measured by the proportion of participants who complete therapy by taking 80% of HCV treatment (both pegylated interferon alpha 2a and ribavirin).[At the end of year 3 when all participant follow-up visits are complete.]