Trial Review

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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/NCT00522808




Registration number
NCT00522808
Ethics application status
Date submitted
29/08/2007
Date registered
30/08/2007
Date last updated
29/09/2008

Titles & IDs
Public title
A Study of the PK, Safety and Antiviral Activity of A-831 in HCV Carriers
Scientific title
A Clinical Pharmacology Study to Determine the Pharmacokinetic , Safety and Tolerability Profile and Antiviral Activity of Multiple Oral Doses of A-831 in Otherwise Healthy Male Hepatitis C Carriers With Compensated Liver Disease
Secondary ID [1] 0 0
CP104
Universal Trial Number (UTN)
Trial acronym
CP104
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 - A-831

Treatment: Drugs: A-831
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety
Timepoint [1] 0 0
Primary outcome [2] 0 0
PK
Timepoint [2] 0 0
Primary outcome [3] 0 0
Tolerability
Timepoint [3] 0 0
Primary outcome [4] 0 0
Antiviral activity
Timepoint [4] 0 0

Eligibility
Key inclusion criteria
- Volunteers will be males of any race aged 18-60 years with a BMI between 18 and 32
kg/m2 at the time of the screening medical

- Volunteers who have given their written informed consent to participate in the study

- Volunteers who are willing and able to comply with the protocol and study procedures

- Volunteers who have a diagnosis of chronic hepatitis C infection and are in good
health (other than history of Hepatitis C infection)
Minimum age
18 Years
Maximum age
60 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
- Voulnteers with concurrent medical conditions or taking concurrent medications

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled 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
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1/Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2008
Sample size
Target
36
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland
Country [2] 0 0
United Kingdom
State/province [2] 0 0
Birmingham
Country [3] 0 0
United Kingdom
State/province [3] 0 0
Dundee

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Arrow Therapeutics
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
DDS, Dundee
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
David Mutimer, Birmingham
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Ed Gane, ACS New Zealand
Address [3] 0 0
Country [3] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The purposes of this study are:

- to determine the safety and tolerability of multiple doses of A-831 at various doses

- to determine how multiple doses of A-831 are distributed through the bloodstream

- to determine if A-831 reduces the amount of Hepatitis C virus in the blood
Trial website
https://clinicaltrials.gov/ct2/show/NCT00522808
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Brian Sanderson
Address 0 0
DDS
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

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

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/ct2/show/NCT00522808