Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000028606
Ethics application status
Approved
Date submitted
19/07/2005
Date registered
19/07/2005
Date last updated
19/01/2006
Type of registration
Prospectively registered

Titles & IDs
Public title
Tenofovir versus Adefovir for the treatment of HBeAg positive chronic hepatitis B
Scientific title
A randomised, phase III, double blind study to evaluate the efficacy and safety of tenofovir DF versus adefovir dipivoxil in the treatment of HBeAg positive chronic hepatitis B to suppress viral replication, amend the course of the disease and decrease morbidity.
Universal Trial Number (UTN)
Trial acronym
GS-US-174-0103
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HBeAg positive chronic hepatitis B 91 0
Condition category
Condition code
Inflammatory and Immune System 112 112 0 0
Liver

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
To compare the efficacy of tenofovir DF 300 mg versus adefovir dipivoxil 10mg over 48 weeks of treatment
Intervention code [1] 39 0
Treatment: Drugs
Comparator / control treatment
Control group
Placebo

Outcomes
Primary outcome [1] 138 0
The primary efficacy parameter is the proportion of patients treated with tenofovir DF 300mg QD versus adefovir dipivoxil 10 mg QD with a complete response. A complete response is defined as serum HBV DNA levels below 400 copies/mL and histologic improvement defined as at least a 2 point reduction in the Knodell necroinflammatory score without worsening in the Knodell fibrosis score.
Timepoint [1] 138 0
At the end of the 48 week treatment period.
Primary outcome [2] 139 0
To compare the safety and tolerability of tenofovir DF 300 mg QD versus adefovir dipivoxil 10mg QD.
Timepoint [2] 139 0
Over the 48 week treatment period.
Secondary outcome [1] 313 0
To evaluate the incidence of drug-resistant mutations between treatment arms and to compare the virological, serological, biochemical and histologic response of tenofovir DF 300mg QD versus adefovir dipivoxil 10mg QD for the treatment of HBeAg positive chronic hepatitis B
Timepoint [1] 313 0
Over 48 weeks of treatment.

Eligibility
Key inclusion criteria
Adult patients (18-69 years of age) with HBeAg positive chronic hepatitis B (HBsAg positive for more than 6 months) with serum HBV DNA >10 to the 6 copies /mL, ALT levels >2 x ULN and less than or equal to 10x ULN and a Knodell necroinflammatory score of greater than or equal to 3 and a Knodell fibrosis score < 4. However, up to 96 patients with cirrhosis, i.e. knodell fibrosis score equal to 4, will be eligible for enrollment. Patients who have not had a bopisy within 6 months at baseline must agree to undergo a liver biopsy prior to randomisation. No evidence of hepatocellular carcinoma (HCC) ie. fetoptotein 50 ng/mL at screening. Patients are wligible if they are treatment naive, ie less than 12 weeks of prior nucleoside or nucleotide (adefovir, dipivoxil or tenofovir DF) treatment. Any previous treatment with nucleosides and nucleotides (eg up to 12 weeks) and interferon (pegylated or not) must have ended at least 6 months prior to the pre-treatment biopsy.
Minimum age
Maximum age
Sex
Can healthy volunteers participate?
Key exclusion criteria
Patients must be without HIV, HCV and HDV infection. Pregnant and breast feeding women will be excluded from the study and patients with decompensated liver disease or a history of decompensated liver disease (ascites, jaundice, encephalopathy or variceal haemorrhage) will be excluded from the study.

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)
A centraloised randomisation procedure will be used whereby numbered bottles will be assigned to patients via an interactive voice response system (IVRS) according to the randomisation code
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomly allocated by IVRS; stratified by ALT levels at screening and geographic region
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/08/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
240
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 154 0
Commercial sector/Industry
Name [1] 154 0
Gilead Sciences Inc
Country [1] 154 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Gilead Sciences Inc
Address
Country
United States of America
Secondary sponsor category [1] 109 0
None
Name [1] 109 0
N/A
Address [1] 109 0
Country [1] 109 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35163 0
Address 35163 0
Country 35163 0
Phone 35163 0
Fax 35163 0
Email 35163 0
Contact person for public queries
Name 9228 0
A/Prof Paul Desmond
Address 9228 0
Department of Gastroenterolgy
St Vincent's Hospital
41 Victoria Parade
Fitzroy VIC 3065
Country 9228 0
Australia
Phone 9228 0
+61 3 92883580
Fax 9228 0
+61 3 92883590
Email 9228 0
[email protected]
Contact person for scientific queries
Name 156 0
A/Prof Paul Desmond
Address 156 0
Department of Gastroenterolgy
St Vincent's Hospital
41 Victoria Parade
Fitzroy VIC 3065
Country 156 0
Australia
Phone 156 0
+61 3 92883580
Fax 156 0
+61 3 92883590
Email 156 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.