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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00142298




Registration number
NCT00142298
Ethics application status
Date submitted
31/08/2005
Date registered
2/09/2005
Date last updated
21/08/2020

Titles & IDs
Public title
Telbivudine in Adults Previously Treated in Idenix-Sponsored Telbivudine Studies
Scientific title
An Open Label Trial of Telbivudine (LdT) in Adults With Chronic Hepatitis B Previously Treated in Idenix-Sponsored Telbivudine Studies
Secondary ID [1] 0 0
NV-02B-022
Secondary ID [2] 0 0
CLDT600A2303
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)

Experimental: telbivudine - telbivudine 600 mg p.o. daily for 104 weeks.


Treatment: Drugs: Telbivudine (LdT)
Telbivudine was to be supplied as white to off-white, oval, bi-convex tablets for the 200 mg tablets and white to off-white ovaloid, slightly curved, beveled edges, film coated tablets for the 600 mg tablets. Study drug (600 mg) was to be self-administered by patients orally (p.o.) in a once daily regimen for 104 weeks; for study consistency, the daily dose had to be taken at the same time each day, with or without food.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants Who Maintained Therapeutic Response [Group A: LdT Pool 2302/015]
Assessment method [1] 0 0
The maintained therapeutic response is defined as hepatitis B virus (HBV) DNA \< 5 log10 copies/mL and either hepatitis Be antigen (HBeAg) loss or alanine aminotransferase (ALT) normalized. HBeAg loss is loss of detectable serum HBeAg in a patient who was HBeAg-positive at feeder baseline. ALT normalized is defined as ALT within normal limits for a patient with an elevated ALT level (\>1.0 × ULN) at either the feeder baseline or feeder screening visit. All efficacy data were analyzed separately for HBeAg-positive and HBeAg-negative patients.
Timepoint [1] 0 0
156 weeks, 208 weeks (from feeder study baseline)
Primary outcome [2] 0 0
Percentage of Participants Who Maintained Therapeutic Response [Group A: LAM Pool 2302/015]
Assessment method [2] 0 0
The maintained therapeutic response is defined as hepatitis B virus (HBV) DNA \< 5 log10 copies/mL and either hepatitis Be antigen (HBeAg) loss or alanine aminotransferase (ALT) normalized. HBeAg loss is loss of detectable serum HBeAg in a patient who was HBeAg-positive at feeder baseline. ALT normalized is defined as ALT within normal limits for a patient with an elevated ALT level (\>1.0 × ULN) at either the feeder baseline or feeder screening visit. All efficacy data were analyzed separately for HBeAg-positive and HBeAg-negative patients.
Timepoint [2] 0 0
52 weeks, 104 weeks
Primary outcome [3] 0 0
Percentage of Participants Who Maintained Therapeutic Response [Group A: Feeder Studies 2401/2402/010]
Assessment method [3] 0 0
The maintained therapeutic response is defined as hepatitis B virus (HBV) DNA \< 5 log10 copies/mL and either hepatitis Be antigen (HBeAg) loss or alanine aminotransferase (ALT) normalized. HBeAg loss is loss of detectable serum HBeAg in a patient who was HBeAg-positive at feeder baseline. ALT normalized is defined as ALT within normal limits for a patient with an elevated ALT level (\>1.0 × ULN) at either the feeder baseline or feeder screening visit. All efficacy data were analyzed separately for HBeAg-positive and HBeAg-negative patients.
Timepoint [3] 0 0
52 weeks, 104 weeks
Primary outcome [4] 0 0
Percentage of Participants With Maintained Clinical Response [Group B: LdT 2301]
Assessment method [4] 0 0
Maintained clinical response is defined as achievement of serum HBV DNA \< 4 log10 copies/mL, normal serum ALT level and improvement or stabilization in Child-Turcotte-Pugh (CTP) score. Total CTP score ranges from 5 to 15; higher scores indicate liver impairment. Improvement is defined as a 2-point or greater reduction in CTP score, and stabilization is defined as a less than 2-point change in CTP score, compared to the patient's baseline value. Analysis was done on the overall per protocol (PP) population and separately for the HBeAg-positive and HBeAg-negative subpopulation.
Timepoint [4] 0 0
156 weeks, 208 weeks (from feeder study baseline)
Primary outcome [5] 0 0
Percentage of Participants With Maintained Clinical Response [Group B: LAM 2301]
Assessment method [5] 0 0
Maintained clinical response is defined as achievement of serum HBV DNA \< 4 log10 copies/mL, normal serum ALT level and improvement or stabilization in Child-Turcotte-Pugh (CTP) score. Total CTP score ranges from 5 to 15; higher scores indicate liver impairment. Improvement is defined as a 2-point or greater reduction in CTP score, and stabilization is defined as a less than 2-point change in CTP score, compared to the patient's baseline value. Analysis was done on the overall per protocol (PP) population and separately for the HBeAg-positive and HBeAg-negative subpopulation.
Timepoint [5] 0 0
52 weeks,104 weeks
Primary outcome [6] 0 0
Percentage of Participants With Sustained Therapeutic Response [Group C: LdT Pool and LAM Pool (2302/015)]
Assessment method [6] 0 0
The primary efficacy endpoint for Group C patients was the percentage of patients with sustained therapeutic response (defined as HBV DNA \< 5 log10 copies/mL and either HBeAg loss or ALT normalized) at Weeks 52 and 104 of off-treatment follow-up. HBeAg loss is loss of detectable serum HBeAg in a patient who was HBeAg-positive at feeder baseline. ALT normalized is ALT within normal limits for a patient with an elevated ALT level (\>1.0 × ULN) at either the feeder baseline or feeder screening visit. All efficacy data were analyzed separately for HBeAg-positive and HBeAg-negative patients.
Timepoint [6] 0 0
52 weeks,104 weeks
Primary outcome [7] 0 0
Percentage of Participants With Sustained Therapeutic Response [Group C: Other Feeder Studies]
Assessment method [7] 0 0
The primary efficacy endpoint for Group C (other feeder studies) was the percentage of patients with sustained therapeutic response (defined as HBV DNA \< 5 log10 copies/mL and either HBeAg loss or ALT normalized) at Weeks 52 and 104 of off-treatment follow-up. Patients were enrolled for off-treatment follow-up after the treatment discontinuation due to efficacy at their last visit of the feeder studies. Hence, patients did not receive study drug except in case of patients who relapsed and reinitiated treatment. No statistical summary was performed , only patient listing was generated.
Timepoint [7] 0 0
52 weeks,104 weeks
Secondary outcome [1] 0 0
To Longitudinally Assess the Longer-term Antiviral Efficacy Achieved With Telbivudine Treatment
Assessment method [1] 0 0
Timepoint [1] 0 0
52 weeks, 104 weeks, 156 weeks, 208 weeks
Secondary outcome [2] 0 0
To Longitudinally Assess the Clinical Efficacy of Longer-term Treatment With Telbivudine
Assessment method [2] 0 0
Timepoint [2] 0 0
52 weeks, 104 weeks, 156 weeks, 208 weeks
Secondary outcome [3] 0 0
To Longitudinally Assess the Durability of HBeAg Responses Achieved With Telbivudine Treatment and Other Previous Treatments in Patients
Assessment method [3] 0 0
Timepoint [3] 0 0
52 weeks, 104 weeks, 156 weeks, 208 weeks
Secondary outcome [4] 0 0
To Determine the Longitudinal Frequency of Virologic Breakthrough and Characterize the Associated Mutations in the HBV Polymerase Gene in HBV DNA Amplified From Sera of Patients With Virologic Breakthrough
Assessment method [4] 0 0
Timepoint [4] 0 0
52 weeks, 104 weeks, 156 weeks, 208 weeks

Eligibility
Key inclusion criteria
* Patient completed a previous qualifying Idenix-Sponsored trial with telbivudine
* Patient was not discontinued from previous Idenix-Sponsored study

Other protocol-defined inclusion criteria may apply
Minimum age
16 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

Other protocol-defined exclusion criteria may apply

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
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
Single group
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
1/03/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/11/2009
Sample size
Target
Accrual to date
Final
1869
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Novartis Investigational Site - Heidelberg
Recruitment postcode(s) [1] 0 0
3084 - Heidelberg
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Hawaii
Country [6] 0 0
United States of America
State/province [6] 0 0
Illinois
Country [7] 0 0
United States of America
State/province [7] 0 0
Massachusetts
Country [8] 0 0
United States of America
State/province [8] 0 0
Michigan
Country [9] 0 0
United States of America
State/province [9] 0 0
Missouri
Country [10] 0 0
United States of America
State/province [10] 0 0
New York
Country [11] 0 0
United States of America
State/province [11] 0 0
North Carolina
Country [12] 0 0
United States of America
State/province [12] 0 0
Pennsylvania
Country [13] 0 0
United States of America
State/province [13] 0 0
Texas
Country [14] 0 0
United States of America
State/province [14] 0 0
Virginia
Country [15] 0 0
Canada
State/province [15] 0 0
Ontario
Country [16] 0 0
China
State/province [16] 0 0
Beijing
Country [17] 0 0
Czechia
State/province [17] 0 0
Praha
Country [18] 0 0
France
State/province [18] 0 0
Paris
Country [19] 0 0
Germany
State/province [19] 0 0
Hannover
Country [20] 0 0
Hong Kong
State/province [20] 0 0
Hong Kong
Country [21] 0 0
India
State/province [21] 0 0
New Delhi
Country [22] 0 0
Israel
State/province [22] 0 0
Nazareth
Country [23] 0 0
Italy
State/province [23] 0 0
Torino
Country [24] 0 0
Korea, Republic of
State/province [24] 0 0
Seoul
Country [25] 0 0
New Zealand
State/province [25] 0 0
Hamilton
Country [26] 0 0
Poland
State/province [26] 0 0
Krakow
Country [27] 0 0
Puerto Rico
State/province [27] 0 0
Santurce
Country [28] 0 0
Singapore
State/province [28] 0 0
Singapore
Country [29] 0 0
Spain
State/province [29] 0 0
Valencia
Country [30] 0 0
Taiwan
State/province [30] 0 0
Tainan
Country [31] 0 0
Thailand
State/province [31] 0 0
Bangkok
Country [32] 0 0
Turkey
State/province [32] 0 0
Istanbul
Country [33] 0 0
United Kingdom
State/province [33] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Novartis Pharmaceuticals
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Merck Sharp & Dohme LLC
Country [1] 0 0

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT00142298