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Trial registered on ANZCTR
Registration number
ACTRN12607000418471
Ethics application status
Approved
Date submitted
7/08/2007
Date registered
17/08/2007
Date last updated
27/02/2008
Type of registration
Retrospectively registered
Titles & IDs
Public title
A pilot phase II open-label study of oglufanide disodium in patients with chronic hepatitis C
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Scientific title
In patients with chronic hepatitis C, does treatment with oglufanide disodium reduce viral load from baseline value?
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Secondary ID [1]
453
0
IM07-02
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Chronic hepatitis C
2224
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Condition category
Condition code
Infection
2367
2367
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0
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Other infectious diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Intranasal oglufanide disodium 0.05 mg twice daily for 21 days
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Intervention code [1]
1935
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Treatment: Drugs
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Comparator / control treatment
None
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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Perecentage with greater than 2-log reduction in viral load.
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Assessment method [1]
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Timepoint [1]
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4 weeks
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Secondary outcome [1]
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1. Duration of response
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Assessment method [1]
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Timepoint [1]
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Based on measurement of viral load at 4-weekly intervals
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Secondary outcome [2]
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2. % with sustained viral response
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Assessment method [2]
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Timepoint [2]
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At 12 and 24 weeks after the start of treatment.
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Secondary outcome [3]
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3. % of patients with greater than 2-fold reduction in serum transaminases
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Assessment method [3]
5358
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Timepoint [3]
5358
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at any time after the start of treatment
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Eligibility
Key inclusion criteria
Serological evidence of infection with hepatitis C virus (HCV), including anti-HCV antibodies and viral load at least 100 time sgreate tha the lower limit of detection.
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Minimum age
18
Years
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Maximum age
65
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Co-infection with hepatitis B or human immunodeficiency virus (HIV)
2. Severe liver disease, or liver disease due to other disorders
3. Renal, hepatic or bone marrow dysfunction
4. Active or suspected cancer or histor of malignancy with high risk of recurrence
5. Organ transplant
6. Substance abuse
7. Women of childbearing potential
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 2
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
8/08/2007
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
17
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Funding & Sponsors
Funding source category [1]
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Commercial sector/Industry
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Name [1]
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Implicit Bioscience Pty Ltd
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Address [1]
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Level 1, 80 Jephson Street, Toowong, QLD 4066
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Country [1]
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Australia
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Primary sponsor type
Commercial sector/Industry
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Name
Implicit Bioscience Pty Ltd
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Address
Level 1, 80 Jephson Street, Toowong, QLD 4066
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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None
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Address [1]
2255
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Country [1]
2255
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Monash Medical Centre
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Ethics committee address [1]
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Clayton VIC
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Ethics committee country [1]
4386
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Australia
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Date submitted for ethics approval [1]
4386
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Approval date [1]
4386
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Ethics approval number [1]
4386
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Summary
Brief summary
The primary purpose of the study is to assess the efficacy of the drug in reducing viral load in patients with chronic HCV infection
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Rachel Fahy
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Address
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Implicit Bioscience Pty Ltd
Level 1
80 Jephson Street
Toowong QLD 4066
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Country
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Australia
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Phone
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+61 7 3721 1242
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Fax
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07 3719 5499
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Email
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[email protected]
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Contact person for scientific queries
Name
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Rachel Fahy
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Address
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Implcit Bioscience Pty Ltd
Level 1
80 Jephson Street
Toowong QLD 4066
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Country
2052
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Australia
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Phone
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+61 7 3721 1242
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Fax
2052
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07 3719 5499
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Email
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[email protected]
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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