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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01120795




Registration number
NCT01120795
Ethics application status
Date submitted
6/05/2010
Date registered
11/05/2010
Date last updated
30/01/2024

Titles & IDs
Public title
Pegylated Interferon and Ribavirin in Hepatitis C Patients on Opioid Pharmacotherapy
Scientific title
Pegylated Interferon Alfa-2a Plus Ribavirin for Patients With Chronic Hepatitis c Virus on Opioid Pharmacotherapy: Virological and Psychological Outcomes
Secondary ID [1] 0 0
HREC 2000.175
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Hepatitis C 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Pegylated interferon and ribavirin
Treatment: Drugs - Pegylated interferon and ribavirin

Experimental: pegylated interferon and ribavirin - Anti hepatitis C agents


Treatment: Drugs: Pegylated interferon and ribavirin
Pegylated interferon 180 ug subcutaneous per week Ribavirin 1000-1200 mg /day for genotype 1 and 800 mg /day orally for genotype non 1 Duration: 48 weeks for genotype 1 and 24 weeks for gentoype non 1

Treatment: Drugs: Pegylated interferon and ribavirin
Pegylated interferon 180 ug/ week subcutaneously Ribavrin 1000-1200 mg /day for genotype 1 and 800 mg/day orally for genotype 2 and 3 Treatment duration 48 weeks for genotype 1 and 24 weeks for genotypes 2 and 3
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Sustained virological response
Timepoint [1] 0 0
24 weeks post cessation of HCV therapy

Eligibility
Key inclusion criteria
1. 18 years of age or older

2. on opioid substitution therapy (methadone or buprenorphine)

3. serologic evidence of chronic hepatitis C infection determined by a detectable
anti-HCV antibody for 6 months or greater with evidence of detectable HCV RNA

4. elevated ALT on at least two occasions at least one month apart within the past 6
months, with at least one during the screening period preceding the initiation of
study drug dosing.

5. HCV treatment-naïve

6. Liver biopsy findings consistent with the diagnosis of chronic hepatitis C infection
(unless contraindicated due to a bleeding disorder)

7. Compensated liver disease (Child-Pugh Grade A clinical classification).

8. All fertile males and females receiving ribavirin were required to be using two forms
of effective contraception during treatment and during the 6 months after treatment

9. Women of child bearing potential were required to have a negative urine or blood
pregnancy test documented within the 24-hour period prior to the first dose of study
drug
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Women who were pregnant, breastfeeding or planning a pregnancy

2. Male partners of women who were pregnant

3. Patients who had previously received therapy with any systemic anti-neoplastic or
immunomodulatory treatment (including supraphysiologic doses of steroids and
radiation) 6 months prior to the first dose of study drug

4. Recipients of any investigational drug 4 weeks or 5 half lives, whichever was longer,
prior to the first dose of study drug

5. A positive test at screening for anti-HAV IgM Ab, HBsAg, anti-HBc IgM Ab, anti-HIV Ab

6. A history or other evidence of a medical condition associated with chronic liver
disease other than HCV

7. Haemoglobin <12 g/dL in women or <13 g/dL in men, a neutrophil count <1500 cells/mm3
or platelet count <90,000 cells/mm3 at screening and serum creatinine level >1.5 times
the upper limit of normal at screening.)

8. A history of a severe seizure disorder or current anticonvulsant use

9. Patients with a history of immunologically-mediated disease, chronic pulmonary disease
associated with functional limitation, severe cardiac disease, coronary artery
disease, cerebrovascular 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

10. Patients with a history of thyroid disease which is poorly controlled on prescribed
medications

11. Evidence of severe retinopathy

12. Evidence of excessive substance abuse as judged by the investigator

13. Patients with an increased baseline risk for anaemia (e.g. thalassaemia,
spherocytosis, history of gastrointestinal bleeding, etc) or for whom anemia would be
medically problematic.

14. Patients with a history of severe psychiatric disease (defined as acute phase of
schizophrenia or bipolar disorder manic, mixed or depressive phase, severe anorexia,
history of severe multiple episodes of self harm, currently screening as high or
moderate suicide risk, current major depressive episode or current psychosis of any
cause at screening)

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/02/2004
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/07/2006
Sample size
Target
Accrual to date
Final
55
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Nepean Hospital - Sydney
Recruitment hospital [2] 0 0
St Vincents Hospital - Sydney
Recruitment hospital [3] 0 0
Western Hospital - Footscray
Recruitment hospital [4] 0 0
Royal Melbourne Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
- Sydney
Recruitment postcode(s) [2] 0 0
3011 - Footscray
Recruitment postcode(s) [3] 0 0
3050 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Melbourne Health
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
The University of New South Wales
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
St Vincent's Hospital, Sydney
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Western Hospital, Australia
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
Monash University
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Commercial sector/Industry
Name [5] 0 0
Hoffmann-La Roche
Address [5] 0 0
Country [5] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to see if treatment of chronic hepatitis C in people who are on
opiate replacement therapy such as methadone or buprenorphine (including patient who still
inject drugs) is safe and effective.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01120795
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Joseph J Sasadeusz, MBBS
Address 0 0
Melbourne Health
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01120795