Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000505505
Ethics application status
Approved
Date submitted
5/12/2006
Date registered
6/12/2006
Date last updated
3/11/2010
Type of registration
Prospectively registered

Titles & IDs
Public title
A phase Ib study of oglufanide disodium (IM862) in patients with chronic HCV infection
Scientific title
A phase Ib dose escalation study of the safety and tolerability of oglufanide disodium (IM862) in patients with chronic hepatitis C virus (HCV) infection
Secondary ID [1] 320 0
Implicit Bioscience: IM07-01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Hepatitis C 1483 0
Condition category
Condition code
Inflammatory and Immune System 1577 1577 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Oglufanide disodium is to be administered for 5 of 7 days for two successive weeks, followed by two weeks without therapy. This 4 week cycle will be repeated 3 times. The first 7 cohorts will receive dose levels of 0.5ug, 5ug, 50ug, 500ug, 5mg, 15mg and 50mg subcutaneously with the 8th cohort receiving 5mg inhaled. Escalation to the next dose will only commence if no adverse event that is severe and/or serious and considered probably or definately related to the study product has been observed by the time all subjects in the previous dose level group have completed their second two week cycle of therapy.
Intervention code [1] 1487 0
Treatment: Drugs
Comparator / control treatment
No comparator.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 2181 0
To evaluate the safety and tolerability profile of chronic intermittently administered oglufanide disodium at seven dose levels and by two different routes of administration
Timepoint [1] 2181 0
Measured at 6 and 12 weeks after treatment has commenced.
Secondary outcome [1] 3803 0
To evaluate the immunoregulatory activity of oglufanide disodium.
Timepoint [1] 3803 0
Measured once weekly for the first 3 weeks of each cycle.
Secondary outcome [2] 3804 0
To determine the effect of oglufanide disodium on HCV ribonucleic acid (RNA) levels in the blood of patients with chronic HCV infection.
Timepoint [2] 3804 0
This will be measured once every two weeks whilst the patient is receiving treatment.

Eligibility
Key inclusion criteria
Serological evidence of hepatitis C infection by anti-HCV antibody test and HCV RNA detectable by PCR; Liver biopsy showing Metavir fibrosis stage = or <2 within 3 or 5 years, for moderate or mild disease respectively; Able to give written informed consent and comply with protocol requirements; Has failed to respond to conventional antiviral therapy, has relapsed, or has declined to receive these drugs (previous ribavirin treatment must be >6 months prior to enrolment).
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Women who are pregnant, breastfeeding or of child-bearing potential who are not using at least two forms of acceptable methods of birth control; Co-infection with HBV or HIV; Patients who are expected to need systemic antiviral therapy at any time during their participation; Renal impairment (creatinine >0.15 mmol/L; Specific enzymes > 5x upper limit of normal, bilirubin> 30umol/L; Haematological abnormalities (Hb <110g/L, lymphocyte count <0.8x10^9/L, platelet count <100x10^9/L); History or evidence of bleeding from oesphageal varices or other conditions consistent with decompensated liver disease; History or evidence of chronic pulmonary disease associated with functional limitations; History of major organ transplantation with an existing functional graft; Haemophilia or any other condition that would preclude liver biopsy; Alcohol intake >30g/day for men or >20g/day for women or evidence of alcohol abuse within 6 months of screening; Poorly controlled diabetes mellitus; Patients taking herbal or antioxidant therapies; Substance abuse with IV or inhaled drugs; Evidence of liver disease due to other disorders (eg. untreated haemochromatosis, alcoholic liver disease, Wilson's disease, autoimmune hepatitis, toxin exposure, alpha1-antitrypsin); Persons currently (or within 3 months prior to enrolment) taking systemic immunosuppressive or immunomodulative medication including interferon (use of topical or inhalant corticosteroids is acceptable); Evidence of ongoing autoimmune disease (clinically manifest vasculitis, ANA titre >640, AMA titre >160, anti smooth muscle antibody titre >160); Acute illness within 72 hours prior to first drug administration; Administration of any investigational drug or vaccine or any registered vaccine within 30 days prior to and during the dosing phase in this study or within 5 half lives of the investigational drug, which ever is shorter; Any medical or social condition that in the opinion of the investigator would interfere with the interpretation or evaluation of the study product; Subjects in whom it is not possible to obtain a pre-dose blood sample without undue trauma or distress; Evidence of an active or suspected cancer or a history of malignancy where the risk of recurrence is >20% within 2 years; Body mass index >36 or <18; Donation or loss of more than 400ml of blood within 2 months prior to anticipated dose administration; History of clinically significant drug allergy; History of a severe seizure disorder or current anticonvulsant use.

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
Other
Other design features
Open label dose escalation
Phase
Phase 1
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Date of first participant enrolment
Anticipated
1/11/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
32
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1722 0
Commercial sector/Industry
Name [1] 1722 0
Implicit Bioscience Pty Ltd
Country [1] 1722 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] 1519 0
None
Name [1] 1519 0
None
Address [1] 1519 0
Country [1] 1519 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3179 0
Princess Alexandra Hospital
Ethics committee address [1] 3179 0
Ethics committee country [1] 3179 0
Australia
Date submitted for ethics approval [1] 3179 0
Approval date [1] 3179 0
14/03/2006
Ethics approval number [1] 3179 0
2005/223

Summary
Brief summary
A phase Ib, open label, dose escalation study of the safety, tolerability and immunogenicity of oglufanide disodium in patients with chronic hepatitis C who have declined or are nonresponsive to conventional antiviral therapy.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27421 0
Address 27421 0
Country 27421 0
Phone 27421 0
Fax 27421 0
Email 27421 0
Contact person for public queries
Name 10676 0
Rachel Fahy
Address 10676 0
Implicit Bioscience Pty Ltd
Level 1, 80 Jephson Street
PO Box 2072
Toowong, QLD 4066
Country 10676 0
Australia
Phone 10676 0
+61 7 3721 1242
Fax 10676 0
+61 7 37195499
Email 10676 0
[email protected]
Contact person for scientific queries
Name 1604 0
Dr Elizabeth Powell
Address 1604 0
Gastroenterology and Hepatology
Princess Alexandra Hospital
Ipswich Road
Woolloongabba, QLD 4102
Country 1604 0
Australia
Phone 1604 0
+61 7 32402035
Fax 1604 0
Email 1604 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.