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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/NCT00132652




Registration number
NCT00132652
Ethics application status
Date submitted
18/08/2005
Date registered
22/08/2005
Date last updated
23/02/2017

Titles & IDs
Public title
Switching Therapy From Lamivudine to Telbivudine Versus Continued Lamivudine in Adults With Chronic Hepatitis B
Scientific title
A Randomized Trial of Switching Antiviral Therapy From Lamivudine to Telbivudine (LdT) vs. Continued Lamivudine Treatment in Adults With Chronic Hepatitis B
Secondary ID [1] 0 0
NV-02B-019
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 - Lamivudine
Treatment: Drugs - Telbivudine

Treatment: Drugs: Lamivudine


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

Outcomes

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

- Patient has compensated liver disease

- Patient has received previous treatment with lamivudine for a duration of at least 3
months and not more than 12 months

Other protocol-defined inclusion criteria may apply.
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Patient is pregnant or breastfeeding

- Patient is co-infected with hepatitis C, hepatitis D or HIV

- Patient previously received antiviral treatment for hepatitis B other than lamivudine
in the preceding 12 months

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
Blinded (masking 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
1/02/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2006
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Westmead
Recruitment postcode(s) [1] 0 0
- Westmead
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
New York
Country [3] 0 0
United States of America
State/province [3] 0 0
Pennsylvania
Country [4] 0 0
Canada
State/province [4] 0 0
Ontario
Country [5] 0 0
Canada
State/province [5] 0 0
Quebec
Country [6] 0 0
China
State/province [6] 0 0
Beijing
Country [7] 0 0
France
State/province [7] 0 0
Nice
Country [8] 0 0
Israel
State/province [8] 0 0
Tel Aviv
Country [9] 0 0
New Zealand
State/province [9] 0 0
Auckland
Country [10] 0 0
Singapore
State/province [10] 0 0
Singapore
Country [11] 0 0
Taiwan
State/province [11] 0 0
Tainan
Country [12] 0 0
Thailand
State/province [12] 0 0
Chiang Mai
Country [13] 0 0
United Kingdom
State/province [13] 0 0
London

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 study is being conducted to compare the safety and effectiveness of switching treatment
from lamivudine to telbivudine (LdT) against continued lamivudine treatment. Results from
patients who were taking lamivudine and then switched to telbivudine will be compared with
the results from patients who continued on lamivudine alone.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00132652
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