Telbivudine Versus Lamivudine in Adults With Decompensated Chronic Hepatitis B and Evidence of Cirrhosis
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ClinicalTrials.gov Identifier: NCT00076336 |
Recruitment Status :
Completed
First Posted : January 22, 2004
Results First Posted : September 5, 2011
Last Update Posted : September 5, 2011
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hepatitis Hepatitis B, Chronic Cirrhosis | Drug: Telbivudine Drug: Lamivudine Drug: Placebo | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 232 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Randomized, Double-Blind Trial of Telbivudine Versus Lamivudine in Adults With Decompensated Chronic Hepatitis B and Evidence of Cirrhosis |
Study Start Date : | December 2003 |
Actual Primary Completion Date : | December 2009 |

Arm | Intervention/treatment |
---|---|
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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Drug: Telbivudine
600mg/day oral tablet for 104 weeks
Other Name: LDT600 Drug: Placebo Telbivudine matching placebo or lamivudine matching placebo tablet. |
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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Drug: Lamivudine
100mg/day oral tablet for 104 weeks Drug: Placebo Telbivudine matching placebo or lamivudine matching placebo tablet. |
- Number of Participants With Clinical Response [ Time Frame: From Baseline to Week 52 ]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.
- Time to Initial Clinical Response [ Time Frame: From Baseline to Week 104 ]Time to Clinical Response defined as the number of days elapsed from the baseline visit to achieving initial Clinical Response.
- Duration of Initial Clinical Response [ Time Frame: Baseline to Week 104 ]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.
- 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 ]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.
- Number of Participants With Improvement, Stabilization, and Worsening in a Modified (3-component) CTP Score [ Time Frame: Baseline and Week 104 ]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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Ages Eligible for Study: | 16 Years to 70 Years (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00076336
United States, Arizona | |
Phoenix, Arizona, United States | |
United States, California | |
Los Angeles, California, United States | |
United States, Colorado | |
Denver, Colorado, United States | |
United States, Indiana | |
Indianapolis, Indiana, United States | |
United States, Minnesota | |
Rochester, Minnesota, United States | |
United States, New York | |
New York, New York, United States | |
United States, Texas | |
Houston, Texas, United States | |
United States, Wisconsin | |
Madison, Wisconsin, United States | |
Australia | |
Heidelburg, Australia | |
Canada | |
Winnipeg, Canada | |
China | |
Hong Kong, China | |
France | |
Villejuif Cedex, France | |
Germany | |
Hannover, Germany | |
India | |
Novartis | |
New Delhi, India | |
Israel | |
Tel Aviv, Israel | |
Korea, Republic of | |
Seoul, Korea, Republic of | |
Latvia | |
Novartis | |
Riga, Latvia | |
Malaysia | |
Novartis | |
Kuala Lumpur, Malaysia | |
New Zealand | |
Auckland, New Zealand | |
Poland | |
Novartis | |
Krakow, Poland | |
Russian Federation | |
Novartis | |
Moscow, Russian Federation | |
Singapore | |
Singapore, Singapore | |
Spain | |
Barcelona, Spain | |
Taiwan | |
Taipei, Taiwan | |
Thailand | |
Bangkok, Thailand | |
Turkey | |
Novartis | |
Istanbul, Turkey | |
United Kingdom | |
London, United Kingdom | |
Vietnam | |
Novartis | |
Hanoi, Vietnam |
Responsible Party: | External Affairs, Novartis Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00076336 |
Other Study ID Numbers: |
CLDT600A2301 |
First Posted: | January 22, 2004 Key Record Dates |
Results First Posted: | September 5, 2011 |
Last Update Posted: | September 5, 2011 |
Last Verified: | August 2011 |
Hepatitis A Hepatitis B Hepatitis B, Chronic Hepatitis Liver Cirrhosis Fibrosis Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Infections Enterovirus Infections Picornaviridae Infections RNA Virus Infections Blood-Borne Infections |
Communicable Diseases Hepadnaviridae Infections DNA Virus Infections Hepatitis, Chronic Pathologic Processes Lamivudine Telbivudine Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antiviral Agents Anti-Infective Agents Anti-HIV Agents Anti-Retroviral Agents |