COVID-19 studies are our top priority. For all other trials, there is a 4-week delay in processing a trial submitted to the ANZCTR and additional delays for updates of registered trials. We appreciate your patience.

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 details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00115245




Registration number
NCT00115245
Ethics application status
Date submitted
21/06/2005
Date registered
22/06/2005
Date last updated
12/05/2015

Titles & IDs
Public title
Telbivudine Versus Adefovir Dipivoxil in Adults With HBegAg-Positive, Compensated Chronic Hepatitis B
Scientific title
A Randomized, Open-Label Trial of Telbivudine Versus Adefovir Dipivoxil in Adults With HBegAg-Positive, Compensated Chronic Hepatitis B
Secondary ID [1] 0 0
NV-02B-018
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Hepatitis B 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 - Telbivudine (LdT)
Treatment: Drugs - Adefovir Dipivoxil

Treatment: Drugs: Telbivudine (LdT)


Treatment: Drugs: Adefovir Dipivoxil


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

Outcomes

Eligibility
Key inclusion criteria
- Documented compensated chronic hepatitis B defined by clinical history compatible with
compensated chronic hepatitis B

- Detectable serum HBsAg at the Screening visit

Other protocol-defined inclusion criteria may apply.
Minimum age
18 Years
Maximum age
70 Years
Gender
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
- Patient is pregnant or breastfeeding.

- Patient is coinfected with hepatitis C virus (HCV), hepatitis D virus (HDV) or HIV

- Patient previously received lamivudine, adefovir dipivoxil, or an investigational
anti-hepatitis B virus (HBV) nucleoside or nucleotide analog at any time

- Patient has received interferon or other immunomodulatory treatment for HBV infection
in the 12 months before screening for this study

Other protocol-defined exclusion criteria may apply.

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
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 hospital [1] 0 0
- Clayton
Recruitment hospital [2] 0 0
- Wooloongabba
Recruitment postcode(s) [1] 0 0
- Clayton
Recruitment postcode(s) [2] 0 0
- Wooloongabba
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
Canada
State/province [3] 0 0
Calgary
Country [4] 0 0
Canada
State/province [4] 0 0
Toronto
Country [5] 0 0
Canada
State/province [5] 0 0
Winnipeg
Country [6] 0 0
China
State/province [6] 0 0
Hong Kong
Country [7] 0 0
France
State/province [7] 0 0
Paris
Country [8] 0 0
Korea, Republic of
State/province [8] 0 0
Seoul
Country [9] 0 0
Singapore
State/province [9] 0 0
Singapore
Country [10] 0 0
Taiwan
State/province [10] 0 0
Taipei
Country [11] 0 0
Thailand
State/province [11] 0 0
Bangkok

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Novartis
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Novartis Pharmaceuticals
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
This research study is being conducted to compare the safety and effectiveness of the
investigational medication, LdT (telbivudine) versus adefovir dipivoxil, a drug approved by
the Food and Drug Administration (FDA) for the treatment of hepatitis B infection. The
results for patients taking LdT will be compared to results for patients taking adefovir
dipivoxil.
Trial website
https://clinicaltrials.gov/show/NCT00115245
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
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