Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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
Scientific title
In patients with chronic hepatitis C, does treatment with oglufanide disodium reduce viral load from baseline value?
Secondary ID [1] 453 0
IM07-02
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic hepatitis C 2224 0
Condition category
Condition code
Infection 2367 2367 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intranasal oglufanide disodium 0.05 mg twice daily for 21 days
Intervention code [1] 1935 0
Treatment: Drugs
Comparator / control treatment
None
Control group
Uncontrolled

Outcomes
Primary outcome [1] 3213 0
Perecentage with greater than 2-log reduction in viral load.
Timepoint [1] 3213 0
4 weeks
Secondary outcome [1] 5356 0
1. Duration of response
Timepoint [1] 5356 0
Based on measurement of viral load at 4-weekly intervals
Secondary outcome [2] 5357 0
2. % with sustained viral response
Timepoint [2] 5357 0
At 12 and 24 weeks after the start of treatment.
Secondary outcome [3] 5358 0
3. % of patients with greater than 2-fold reduction in serum transaminases
Timepoint [3] 5358 0
at any time after the start of treatment

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.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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

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 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
8/08/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
17
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 2481 0
Commercial sector/Industry
Name [1] 2481 0
Implicit Bioscience Pty Ltd
Country [1] 2481 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Implicit Bioscience Pty Ltd
Address
Level 1, 80 Jephson Street, Toowong, QLD 4066
Country
Australia
Secondary sponsor category [1] 2255 0
None
Name [1] 2255 0
None
Address [1] 2255 0
Country [1] 2255 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4386 0
Monash Medical Centre
Ethics committee address [1] 4386 0
Clayton VIC
Ethics committee country [1] 4386 0
Australia
Date submitted for ethics approval [1] 4386 0
Approval date [1] 4386 0
Ethics approval number [1] 4386 0

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
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27749 0
Address 27749 0
Country 27749 0
Phone 27749 0
Fax 27749 0
Email 27749 0
Contact person for public queries
Name 11124 0
Rachel Fahy
Address 11124 0
Implicit Bioscience Pty Ltd
Level 1
80 Jephson Street
Toowong QLD 4066
Country 11124 0
Australia
Phone 11124 0
+61 7 3721 1242
Fax 11124 0
07 3719 5499
Email 11124 0
[email protected]
Contact person for scientific queries
Name 2052 0
Rachel Fahy
Address 2052 0
Implcit Bioscience Pty Ltd
Level 1
80 Jephson Street
Toowong QLD 4066
Country 2052 0
Australia
Phone 2052 0
+61 7 3721 1242
Fax 2052 0
07 3719 5499
Email 2052 0
[email protected]

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.