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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/NCT00076336
Registration number
NCT00076336
Ethics application status
Date submitted
20/01/2004
Date registered
22/01/2004
Date last updated
5/09/2011
Titles & IDs
Public title
Telbivudine Versus Lamivudine in Adults With Decompensated Chronic Hepatitis B and Evidence of Cirrhosis
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Scientific title
Randomized, Double-Blind Trial of Telbivudine Versus Lamivudine in Adults With Decompensated Chronic Hepatitis B and Evidence of Cirrhosis
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Secondary ID [1]
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CLDT600A2301
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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:
Hepatitis
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Hepatitis B, Chronic
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Cirrhosis
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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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Inflammatory and Immune System
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Connective tissue diseases
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Inflammatory and Immune System
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Other inflammatory or immune system disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Telbivudine
Treatment: Drugs - Lamivudine
Treatment: Drugs - Placebo
Experimental: Telbivudine 600 mg - Participants received Telbivudine 600 mg and a matching lamivudine placebo orally once a day for up to 104 weeks. Participants were followed-up for 16 weeks post-treatment.
Active Comparator: Lamivudine 100 mg - Lamivudine 100 mg and a Telbivudine matching placebo orally once a day for up to 104 weeks. Participants were followed-up for 16 weeks post-treatment.
Treatment: Drugs: Telbivudine
600mg/day oral tablet for 104 weeks
Treatment: Drugs: Lamivudine
100mg/day oral tablet for 104 weeks
Treatment: Drugs: Placebo
Telbivudine matching placebo or lamivudine matching placebo tablet.
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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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Number of Participants With Clinical Response
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Assessment method [1]
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Clinical response defined as achieving all of the following 3 criteria on at least 2 consecutive visits or at the last on-treatment visit: Serum hepatitis B virus (HBV) DNA < 4 log10 copies/mL, normal Alanine transaminase (ALT) level (ALT = Upper Limit of Normal (ULN)), and improvement (a 2- point or greater reduction in Child-Turcotte-Pugh (CTP) score) or stabilization (not more than a 1-point change in CTP score), compared to the baseline value. CTP scores range from 5-15, higher scores indicate more liver impairment. For Improvement/Stabilization, either of the individual criteria were met.
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Timepoint [1]
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From Baseline to Week 52
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Secondary outcome [1]
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Time to Initial Clinical Response
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Assessment method [1]
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Time to Clinical Response defined as the number of days elapsed from the baseline visit to achieving initial Clinical Response.
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Timepoint [1]
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From Baseline to Week 104
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Secondary outcome [2]
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Duration of Initial Clinical Response
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Assessment method [2]
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Kaplan-Meier method was used. The duration was calculated as: date of last visit before initial loss of clinical response - date of initial clinical response occurred+1. If a patient did not lose clinical response, it was then censored at the efficacy overall censoring date.
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Timepoint [2]
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Baseline to Week 104
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Secondary outcome [3]
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Number of Participants With Improvement, Stabilization, and Worsening in Child-Turcotte-Pugh (CTP) Score at Week 52 and Week 104
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Assessment method [3]
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Child-Turcotte-Pugh (CTP) uses 2 clinical variables, ascites and encephalopathy, and 3 laboratory parameters, serum bilirubin, albumin, and prothrombin time. Each variable is assigned a score from 1 to 3, with the combined score comprising the CTP score range of 5 to 15 points. Higher scores indicate more impaired liver function. "Worsening" of CTP score was defined as a 2-point or greater increase from baseline, "improvement" in CTP score was defined as a 2-point or greater reduction from baseline, and "stabilization" of CTP score was defined as a change of 1-point or less from baseline.
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Timepoint [3]
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From Baseline to weeks 52 and 104
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Secondary outcome [4]
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Number of Participants With Improvement, Stabilization, and Worsening in a Modified (3-component) CTP Score
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Assessment method [4]
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Modified CTP was calculated using the 3 biochemical-components (serum bilirubin, albumin, and prothrombin). Total scores range from 3-9; higher scores indicate more liver impairment. Improvement was defined as 2-point or greater reduction in score from baseline. Stabilization comprises a score change of 1-point or less from baseline. Worsening of CTP score was defined as a 2-point or greater increase from baseline. The rationale for assessing changes in this modified (3-component) CTP score is that this maneuver removed the two subjective components of CTP scoring (ascites and encephalopathy).
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Timepoint [4]
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Baseline and Week 104
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Eligibility
Key inclusion criteria
- Documented decompensated chronic hepatitis B defined by all of the following: 1.
Clinical history compatible with decompensated chronic hepatitis B related cirrhosis;
2. Child-Turcotte-Pugh score > 7 points.
- Evidence of hepatic cirrhosis or portal hypertension.
Other protocol-defined inclusion criteria may apply.
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Minimum age
16
Years
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Maximum age
70
Years
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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 coinfected with hepatitis C virus (HCV), hepatitis D virus (HDV), or Human
immunodeficiency virus (HIV).
- Patient previously received lamivudine, adefovir, 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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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
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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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
1/12/2003
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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
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Sample size
Target
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Accrual to date
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Final
232
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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- Heidelburg
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Recruitment postcode(s) [1]
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- Heidelburg
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Recruitment outside Australia
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United States of America
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State/province [1]
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Arizona
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United States of America
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California
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United States of America
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Colorado
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United States of America
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Indiana
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United States of America
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Minnesota
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United States of America
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New York
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Texas
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United States of America
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Wisconsin
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Canada
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Winnipeg
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China
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Hong Kong
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France
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Villejuif Cedex
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Germany
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Hannover
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India
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New Delhi
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Israel
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Tel Aviv
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Korea, Republic of
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Seoul
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Latvia
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Riga
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Malaysia
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Kuala Lumpur
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New Zealand
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Auckland
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Poland
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Krakow
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Russian Federation
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Moscow
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Singapore
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Singapore
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Spain
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Barcelona
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Taiwan
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Taipei
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Thailand
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Bangkok
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Turkey
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Istanbul
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United Kingdom
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London
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Vietnam
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State/province [27]
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Hanoi
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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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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This research study was conducted to compare the safety and effectiveness of the
investigational medication, LdT (Telbivudine) versus Lamivudine, a drug currently approved by
the US, European and Asian Health Authorities for the treatment of Hepatitis B infection. The
results for patients taking LdT will be compared to results for patients taking lamivudine.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00076336
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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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Contact person for public queries
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00076336
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