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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/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
Sex
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
1/11/2004
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/08/2006
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/ct2/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