- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00076336
Telbivudine Versus Lamivudine in Adults With Decompensated Chronic Hepatitis B and Evidence of Cirrhosis
August 4, 2011 updated by: Novartis Pharmaceuticals
Randomized, Double-Blind Trial of Telbivudine Versus Lamivudine in Adults With Decompensated Chronic Hepatitis B and Evidence of Cirrhosis
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Multicenter, multinational, randomized, double-blind study designed to compare the safety and efficacy of telbivudine (600 mg/day) versus lamivudine (100 mg/day) for 104 weeks in adults with decompensated chronic hepatitis B and evidence of cirrhosis.
Patients were pre-stratified by screening Child-Turcotte-Pugh score (CTP score < 9 or ≥ 9) and ALT level (within normal limits (WNL) or > 1.0 x ULN) to help assure similar degrees of hepatic insufficiency and liver inflammation on both treatment arms.
After 104 weeks of treatment, participants were followed-up with for an additional 16 weeks.
Study Type
Interventional
Enrollment (Actual)
232
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Heidelburg, Australia
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Winnipeg, Canada
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Hong Kong, China
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Villejuif Cedex, France
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Hannover, Germany
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New Delhi, India
- Novartis
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Tel Aviv, Israel
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Seoul, Korea, Republic of
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Riga, Latvia
- Novartis
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Kuala Lumpur, Malaysia
- Novartis
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Auckland, New Zealand
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Krakow, Poland
- Novartis
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Moscow, Russian Federation
- Novartis
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Singapore, Singapore
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Barcelona, Spain
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Taipei, Taiwan
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Bangkok, Thailand
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Istanbul, Turkey
- Novartis
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London, United Kingdom
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Arizona
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Phoenix, Arizona, United States
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California
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Los Angeles, California, United States
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Colorado
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Denver, Colorado, United States
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Indiana
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Indianapolis, Indiana, United States
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Minnesota
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Rochester, Minnesota, United States
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New York
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New York, New York, United States
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Texas
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Houston, Texas, United States
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Wisconsin
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Madison, Wisconsin, United States
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Hanoi, Vietnam
- Novartis
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 70 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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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.
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600mg/day oral tablet for 104 weeks
Other Names:
Telbivudine matching placebo or lamivudine matching placebo tablet.
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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.
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Telbivudine matching placebo or lamivudine matching placebo tablet.
100mg/day oral tablet for 104 weeks
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Number of Participants With Clinical Response
Time Frame: From Baseline to Week 52
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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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From Baseline to Week 52
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Time to Initial Clinical Response
Time Frame: From Baseline to Week 104
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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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From Baseline to Week 104
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Duration of Initial Clinical Response
Time Frame: Baseline to Week 104
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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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Baseline to Week 104
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Number of Participants With Improvement, Stabilization, and Worsening in Child-Turcotte-Pugh (CTP) Score at Week 52 and Week 104
Time Frame: From Baseline to weeks 52 and 104
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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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From Baseline to weeks 52 and 104
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Number of Participants With Improvement, Stabilization, and Worsening in a Modified (3-component) CTP Score
Time Frame: Baseline and Week 104
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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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Baseline and Week 104
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2003
Primary Completion (Actual)
December 1, 2009
Study Registration Dates
First Submitted
January 20, 2004
First Submitted That Met QC Criteria
January 21, 2004
First Posted (Estimate)
January 22, 2004
Study Record Updates
Last Update Posted (Estimate)
September 5, 2011
Last Update Submitted That Met QC Criteria
August 4, 2011
Last Verified
August 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Liver Diseases
- Hepatitis, Viral, Human
- Hepadnaviridae Infections
- DNA Virus Infections
- Enterovirus Infections
- Picornaviridae Infections
- Hepatitis, Chronic
- Fibrosis
- Hepatitis B
- Hepatitis
- Hepatitis A
- Hepatitis B, Chronic
- Liver Cirrhosis
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Reverse Transcriptase Inhibitors
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Anti-HIV Agents
- Anti-Retroviral Agents
- Lamivudine
- Telbivudine
Other Study ID Numbers
- CLDT600A2301
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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