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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00781976




Registration number
NCT00781976
Ethics application status
Date submitted
28/10/2008
Date registered
29/10/2008
Date last updated
31/03/2010

Titles & IDs
Public title
Antiviral Activity of AZD7295 in HCV Carriers
Scientific title
A Randomised, DB, PC Study to Determine the PK, Safety and Tolerability Profile and Antiviral Activity of Multiple Oral Doses of AZD7295 in Otherwise Healthy Male and Female Hepatitis C Carriers With Compensated Liver Disease
Secondary ID [1] 0 0
HCV689-102
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
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 - AZD7295
Treatment: Drugs - Placebo

Placebo Comparator: 1 -

Active Comparator: 2 -


Treatment: Drugs: AZD7295
700mg per day maximum

Treatment: Drugs: Placebo
matched placebo

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

Outcomes
Primary outcome [1] 0 0
Plasma AZD7295 concentrations and pharmacokinetics
Timepoint [1] 0 0
5 days

Eligibility
Key inclusion criteria
- HCV carrier
Minimum age
18 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- 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?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
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)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Arrow Therapeutics
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
PK, safety study of AZD7295 in HCV carriers
Trial website
https://clinicaltrials.gov/show/NCT00781976
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Ed Gane
Address 0 0
Auckland Clinical Services
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

Summary results
Other publications