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Trial registered on ANZCTR


Registration number
ACTRN12605000682640
Ethics application status
Approved
Date submitted
13/09/2005
Date registered
21/10/2005
Date last updated
21/10/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
A single-arm, open-label, multi-centre pilot study evaluating the efficacy and safety of Ro 25-8310 combination therapy with Ro 20-9963 in pateints with chronic hepatitis C attending a methdone clinic
Scientific title
A single-arm, open-label, multi-centre pilot study evaluating the efficacy and safety of Ro 25-8310 combination therapy with Ro 20-9963 in pateints with chronic hepatitis C attending a methdone clinic
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic hepatitis C 830 0
Condition category
Condition code
Inflammatory and Immune System 897 897 0 0
Liver

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Combination therapy
Intervention code [1] 587 0
Treatment: Drugs
Comparator / control treatment
Control group
Uncontrolled

Outcomes
Primary outcome [1] 1162 0
To evaluate the effect of R0 25-8310 combination therapy on the clearance of HCV viraemia (sustained virological response) in recent injecting drug users with chronic hepatitis C (CHC) virus infection treated with pharmacotherapy.
Timepoint [1] 1162 0
24 weeks after treatment end.
Secondary outcome [1] 2127 0
To evaluate the proportion of patients who comply with the treatment regimen as defined as completion of at least 80% of treatment visits.
Timepoint [1] 2127 0
Secondary outcome [2] 2128 0
To evaluate the psychological impact of therapy.
Timepoint [2] 2128 0
Secondary outcome [3] 2129 0
To evaluate the impact of therpy on quality of life.
Timepoint [3] 2129 0
Secondary outcome [4] 2130 0
To evaluate the effect of therapy on injecting behaviour.
Timepoint [4] 2130 0
Secondary outcome [5] 2131 0
To evaluate the impact of therapy on pharmacotherapy.
Timepoint [5] 2131 0

Eligibility
Key inclusion criteria
Serological evidence of chronic hepatitis C infection by an anti-HCV antibody test for > 6 months; Detectable serum HCV-RNA; elevated serum ALT activity documented on at least two occasions at least one month apart withinthe last 6 months; liver biopsy findings consistant with the diagnosis of chronic hepatitis C infection with or without compensated cirrhosis; compensated liver disease; have had an episode of injecting drug use with 6 months of screening; on a recognized pharmacotherapy detoxification program such as Methadone, Buprenorhine, or Naltrexone.
Minimum age
Not stated
Maximum age
Not stated
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Positive test at screening for anti-HAV IgM Ab, HBsAg, anti-HBc IgM Ab, anti-HIV Ab; History of other medical condition associated with chronic liver disease other than HCV.

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
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 988 0
Government body
Name [1] 988 0
Melbourne Health
Address [1] 988 0
Country [1] 988 0
Australia
Primary sponsor type
Government body
Name
Melbourne Health
Address
Country
Australia
Secondary sponsor category [1] 852 0
Commercial sector/Industry
Name [1] 852 0
F.Hoffman-La Roche
Address [1] 852 0
Country [1] 852 0
Switzerland

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36154 0
Address 36154 0
Country 36154 0
Phone 36154 0
Fax 36154 0
Email 36154 0
Contact person for public queries
Name 9776 0
Dr Joe Sasadeusz
Address 9776 0
Victorian Infectious Diseases Service
Centre for Clinical Research Excellence in Infectious Diseases
Royal Melbourne Hospital
9 Niorth 9th floor
Grattan St
Parkville VIC 3050
Country 9776 0
Australia
Phone 9776 0
+61 3 93427212
Fax 9776 0
Email 9776 0
Joe.Sasadeusz@mh.org.au
Contact person for scientific queries
Name 704 0
Dr Joe Sasadeusz
Address 704 0
Victorian Infectious Diseases Service
Centre for Clinical Research Excellence in Infectious Diseases
Royal Melbourne Hospital
9 Niorth 9th floor
Grattan St
Parkville VIC 3050
Country 704 0
Australia
Phone 704 0
+61 3 93427212
Fax 704 0
Email 704 0
Joe.Sasadeusz@mh.org.au

No information has been provided regarding IPD availability
Summary results
No Results