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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/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
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Scientific title
An Open Label Trial of Telbivudine (LdT) in Adults With Chronic Hepatitis B Previously Treated in Idenix-Sponsored Telbivudine Studies
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Secondary ID [1]
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NV-02B-022
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Secondary ID [2]
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CLDT600A2303
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Chronic Hepatitis B
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Condition category
Condition code
Infection
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Other infectious diseases
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Oral and Gastrointestinal
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants Who Maintained Therapeutic Response [Group A: LdT Pool 2302/015]
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Assessment method [1]
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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.
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Timepoint [1]
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156 weeks, 208 weeks (from feeder study baseline)
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Primary outcome [2]
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Percentage of Participants Who Maintained Therapeutic Response [Group A: LAM Pool 2302/015]
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Assessment method [2]
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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.
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Timepoint [2]
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52 weeks, 104 weeks
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Primary outcome [3]
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Percentage of Participants Who Maintained Therapeutic Response [Group A: Feeder Studies 2401/2402/010]
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Assessment method [3]
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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.
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Timepoint [3]
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52 weeks, 104 weeks
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Primary outcome [4]
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Percentage of Participants With Maintained Clinical Response [Group B: LdT 2301]
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Assessment method [4]
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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.
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Timepoint [4]
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156 weeks, 208 weeks (from feeder study baseline)
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Primary outcome [5]
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Percentage of Participants With Maintained Clinical Response [Group B: LAM 2301]
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Assessment method [5]
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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.
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Timepoint [5]
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52 weeks,104 weeks
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Primary outcome [6]
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Percentage of Participants With Sustained Therapeutic Response [Group C: LdT Pool and LAM Pool (2302/015)]
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Assessment method [6]
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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.
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Timepoint [6]
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52 weeks,104 weeks
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Primary outcome [7]
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Percentage of Participants With Sustained Therapeutic Response [Group C: Other Feeder Studies]
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Assessment method [7]
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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.
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Timepoint [7]
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52 weeks,104 weeks
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Secondary outcome [1]
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To Longitudinally Assess the Longer-term Antiviral Efficacy Achieved With Telbivudine Treatment
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Assessment method [1]
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Timepoint [1]
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52 weeks, 104 weeks, 156 weeks, 208 weeks
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Secondary outcome [2]
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To Longitudinally Assess the Clinical Efficacy of Longer-term Treatment With Telbivudine
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Assessment method [2]
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Timepoint [2]
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52 weeks, 104 weeks, 156 weeks, 208 weeks
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Secondary outcome [3]
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To Longitudinally Assess the Durability of HBeAg Responses Achieved With Telbivudine Treatment and Other Previous Treatments in Patients
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Assessment method [3]
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Timepoint [3]
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52 weeks, 104 weeks, 156 weeks, 208 weeks
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Secondary outcome [4]
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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
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Assessment method [4]
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Timepoint [4]
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52 weeks, 104 weeks, 156 weeks, 208 weeks
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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
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Minimum age
16
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Maximum age
70
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
N/A
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/03/2005
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/11/2009
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Sample size
Target
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Accrual to date
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Final
1869
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Novartis Investigational Site - Heidelberg
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Recruitment postcode(s) [1]
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3084 - Heidelberg
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Arizona
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Country [2]
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United States of America
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State/province [2]
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California
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Country [3]
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United States of America
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State/province [3]
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Florida
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Country [4]
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United States of America
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State/province [4]
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Georgia
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Country [5]
0
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United States of America
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State/province [5]
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Hawaii
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Country [6]
0
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United States of America
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State/province [6]
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Illinois
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Country [7]
0
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United States of America
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State/province [7]
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Massachusetts
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Country [8]
0
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United States of America
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State/province [8]
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Michigan
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Country [9]
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United States of America
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State/province [9]
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Missouri
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Country [10]
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United States of America
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State/province [10]
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New York
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Country [11]
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United States of America
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State/province [11]
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North Carolina
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Country [12]
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United States of America
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State/province [12]
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Pennsylvania
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Country [13]
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United States of America
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State/province [13]
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Texas
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Country [14]
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United States of America
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State/province [14]
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Virginia
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Country [15]
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Canada
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State/province [15]
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Ontario
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Country [16]
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China
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State/province [16]
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Beijing
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Country [17]
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Czechia
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State/province [17]
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Praha
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Country [18]
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France
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State/province [18]
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Paris
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Country [19]
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Germany
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State/province [19]
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Hannover
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Hong Kong
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State/province [20]
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Hong Kong
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Country [21]
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India
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State/province [21]
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New Delhi
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Country [22]
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Israel
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State/province [22]
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Nazareth
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Italy
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State/province [23]
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Torino
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Country [24]
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Korea, Republic of
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State/province [24]
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Seoul
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Country [25]
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New Zealand
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State/province [25]
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Hamilton
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Country [26]
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Poland
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State/province [26]
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Krakow
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Puerto Rico
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State/province [27]
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Santurce
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Country [28]
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Singapore
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State/province [28]
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Singapore
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Country [29]
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Spain
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State/province [29]
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Valencia
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Country [30]
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Taiwan
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State/province [30]
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Tainan
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Country [31]
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Thailand
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State/province [31]
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Bangkok
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Country [32]
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Turkey
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State/province [32]
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Istanbul
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Country [33]
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United Kingdom
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State/province [33]
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London
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Novartis Pharmaceuticals
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Address
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Other collaborator category [1]
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Commercial sector/Industry
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Name [1]
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Merck Sharp & Dohme LLC
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Address [1]
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Ethics approval
Ethics application status
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Summary
Brief summary
This trial is being conducted as an open-label, extended-term study for patients with chronic
hepatitis B who have previously completed an Idenix-sponsored trial with telbivudine.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00142298
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00142298
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