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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/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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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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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/study/NCT00076336
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Trial related presentations / publications
E.J. Gane, H.L. Chan, G. Choudhuri, D.J. Suh4, A. Chutaputti, R. Safadi, T. Tanwandee, S. Thongsawat, N. Assy, S.K. Sarin, W. Bao, A. Trylesinski, C. Avila. TREATMENT OF DECOMPENSATED HBV-CIRRHOSIS: RESULTS FROM 2-YEARS RANDOMIZED TRIAL WITH TELBIVUDINE OR LAMIVUDINE. Journal of Hepatology 52, Supplement 1, Page S4. April 2010
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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 scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Type
Citations or Other Details
Journal
E.J. Gane, H.L. Chan, G. Choudhuri, D.J. Suh4, A. ...
[
More Details
]
Results are available at
https://clinicaltrials.gov/study/NCT00076336
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