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Telbivudine Versus Lamivudine in Adults With Decompensated Chronic Hepatitis B and Evidence of Cirrhosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00076336
Recruitment Status : Completed
First Posted : January 22, 2004
Results First Posted : September 5, 2011
Last Update Posted : September 5, 2011
Sponsor:
Information provided by:
Novartis

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Hepatitis
Hepatitis B, Chronic
Cirrhosis
Interventions Drug: Telbivudine
Drug: Lamivudine
Drug: Placebo
Enrollment 232
Recruitment Details  
Pre-assignment Details 232 patients randomized. One randomized patient in the telbivudine treatment group discontinued prior to commencing treatment and was excluded from the intent to treat (ITT) population. Three randomized patients (two in lamivudine group and one in telbivudine group) had no HBV DNA assessments after baseline and were excluded from ITT population.
Arm/Group Title Telbivudine 600 mg Lamivudine 100 mg
Hide Arm/Group Description Participants received Telbivudine 600 mg and a matching placebo to lamivudine orally once a day for up to 104 weeks, followed by a 16-week follow-up period. Participants received Lamivudine 100 mg and matching placebo to Telbivudine orally once a day for up to 104 weeks, followed by a 16-week follow-up period.
Period Title: Overall Study
Started 116 116
Safety Population 115 [1] 116
Intent to Treat (ITT) Population 114 [2] 114 [3]
Completed Week 52 97 94
Completed Week 104 70 62
Completed 64 60
Not Completed 52 56
Reason Not Completed
Death             13             17
Adverse Event             4             4
Lost to Follow-up             4             4
Non-Compliance             2             0
Creatinine Clearance < 30 or Dialysis             0             1
Patient, Investigator, Sponsor request             8             6
Liver Transplantation             3             3
Virologic Breakthrough             14             16
Treatment failure             4             5
[1]
1 patient was randomized but never received study drug and not included in safety population.
[2]
1 patient had no HBV DNA assessments after baseline and was excluded from ITT population.
[3]
2 patients had no HBV DNA assessments after baseline and were excluded from ITT population.
Arm/Group Title Telbivudine 600 mg Lamivudine 100 mg Total
Hide Arm/Group Description Participants received Telbivudine 600 mg and a matching placebo to lamivudine orally once a day for up to 104 weeks, followed by a 16-week follow-up period. Participants received Lamivudine 100 mg and matching placebo to Telbivudine orally once a day for up to 104 weeks, followed by a 16-week follow-up period. Total of all reporting groups
Overall Number of Baseline Participants 114 114 228
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 114 participants 114 participants 228 participants
49.6  (10.88) 51.9  (9.98) 50.8  (10.48)
[1]
Measure Description: Baseline measures are based on intention to treat (ITT) population.
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 114 participants 114 participants 228 participants
< 30 years 6 2 8
Between 30 and 50 years 44 44 88
> 50 years 64 68 132
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 114 participants 114 participants 228 participants
Female
27
  23.7%
33
  28.9%
60
  26.3%
Male
87
  76.3%
81
  71.1%
168
  73.7%
1.Primary Outcome
Title Number of Participants With Clinical Response
Hide Description 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 Frame From Baseline to Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was on the intention-to-treat (ITT) population.
Arm/Group Title Telbivudine 600 mg Lamivudine 100 mg
Hide Arm/Group Description:
Participants received Telbivudine 600 mg and a matching placebo to lamivudine orally once a day for up to 104 weeks, followed by a 16-week follow-up period.
Participants received Lamivudine 100 mg and matching placebo to Telbivudine orally once a day for up to 104 weeks, followed by a 16-week follow-up period.
Overall Number of Participants Analyzed 114 114
Measure Type: Number
Unit of Measure: Participants
Clinical Response 65 62
HBV DNA < 4log10copies/mL 85 82
Normal ALT 78 81
Improvement/stabilization in CTP 96 96
Improvement in CTP (reduction ≥ 2) 34 43
Stabilization in CTP (absolute change ≤ 1) 56 48
2.Secondary Outcome
Title Time to Initial Clinical Response
Hide Description Time to Clinical Response defined as the number of days elapsed from the baseline visit to achieving initial Clinical Response.
Time Frame From Baseline to Week 104
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was on intention-to-treat (ITT) population. Only the observed time to initial clinical response was summarized.
Arm/Group Title Telbivudine 600 mg Lamivudine 100 mg
Hide Arm/Group Description:
Participants received Telbivudine 600 mg and a matching placebo to lamivudine orally once a day for up to 104 weeks, followed by a 16-week follow-up period.
Participants received Lamivudine 100 mg and matching placebo to Telbivudine orally once a day for up to 104 weeks, followed by a 16-week follow-up period.
Overall Number of Participants Analyzed 95 92
Mean (Standard Deviation)
Unit of Measure: Days
137.5  (126.14) 125.2  (111.24)
3.Secondary Outcome
Title Duration of Initial Clinical Response
Hide Description 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.
Time Frame Baseline to Week 104
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was on intention-to-treat (ITT) population. Only patients who achieved clinical response were considered.
Arm/Group Title Telbivudine 600 mg Lamivudine 100 mg
Hide Arm/Group Description:
Participants received Telbivudine 600 mg and a matching placebo to lamivudine orally once a day for up to 104 weeks, followed by a 16-week follow-up period.
Participants received Lamivudine 100 mg and matching placebo to Telbivudine orally once a day for up to 104 weeks, followed by a 16-week follow-up period.
Overall Number of Participants Analyzed 95 92
Mean (Standard Error)
Unit of Measure: Days
473.1  (26.13) 456.3  (24.97)
4.Secondary Outcome
Title Number of Participants With Improvement, Stabilization, and Worsening in Child-Turcotte-Pugh (CTP) Score at Week 52 and Week 104
Hide Description 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.
Time Frame From Baseline to weeks 52 and 104
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was done per intention-to-treat (ITT) population. Last Observation Carried Forward (LOCF) was utilized for missing data, with the exception of missing observations due to treatment failure, death or AE, which were imputed as "worsening" CTP.
Arm/Group Title Telbivudine 600 mg Lamivudine 100 mg
Hide Arm/Group Description:
Participants received Telbivudine 600 mg and a matching placebo to lamivudine orally once a day for up to 104 weeks, followed by a 16-week follow-up period.
Participants received Lamivudine 100 mg and matching placebo to Telbivudine orally once a day for up to 104 weeks, followed by a 16-week follow-up period.
Overall Number of Participants Analyzed 114 114
Measure Type: Number
Unit of Measure: Participants
Improvement At Week 52 36 44
Stabilization At Week 52 60 52
Worsening At Week 52 18 18
Improvement At Week 104 44 46
Stabilization At Week 104 42 38
Worsening At Week 104 28 30
5.Secondary Outcome
Title Number of Participants With Improvement, Stabilization, and Worsening in a Modified (3-component) CTP Score
Hide Description 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).
Time Frame Baseline and Week 104
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was done on the intention-to-treat (ITT) population. Last Observation Carried Forward (LOCF) was utilized for missing data, with the exception of missing observations due to treatment failure, death or AE, which were imputed as "worsening" CTP.
Arm/Group Title Telbivudine 600 mg Lamivudine 100 mg
Hide Arm/Group Description:
Participants received Telbivudine 600 mg and a matching placebo to lamivudine orally once a day for up to 104 weeks, followed by a 16-week follow-up period.
Participants received Lamivudine 100 mg and matching placebo to Telbivudine orally once a day for up to 104 weeks, followed by a 16-week follow-up period.
Overall Number of Participants Analyzed 114 114
Measure Type: Number
Unit of Measure: Participants
Improvement at Week 104 30 31
Stabilization at Week 104 57 54
Worsening at Week 104 27 29
Time Frame [Not Specified]
Adverse Event Reporting Description Adverse event data is provided for the "on- treatment" period - i.e. any AEs started in the period of first dose date to last dose date + 30 days (all inclusive). For follow-up period, no individual preferred terms were reported in any treatment group. Hence, AE for follow-up period is not included here.
 
Arm/Group Title Telbivudine 600 mg Lamivudine 100 mg
Hide Arm/Group Description Participants received Telbivudine 600 mg and a matching placebo to lamivudine orally once a day for up to 104 weeks, followed by a 16-week follow-up period. Participants received Lamivudine 100 mg and matching placebo to Telbivudine orally once a day for up to 104 weeks, followed by a 16-week follow-up period.
All-Cause Mortality
Telbivudine 600 mg Lamivudine 100 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Telbivudine 600 mg Lamivudine 100 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   59/115 (51.30%)   68/116 (58.62%) 
Blood and lymphatic system disorders     
Anaemia  1  0/115 (0.00%)  1/116 (0.86%) 
Cardiac disorders     
Sinus bradycardia  1  1/115 (0.87%)  0/116 (0.00%) 
Gastrointestinal disorders     
Abdominal pain  1  2/115 (1.74%)  0/116 (0.00%) 
Abdominal pain upper  1  1/115 (0.87%)  0/116 (0.00%) 
Abdominal strangulated hernia  1  0/115 (0.00%)  1/116 (0.86%) 
Ascites  1  11/115 (9.57%)  2/116 (1.72%) 
Duodenal ulcer  1  0/115 (0.00%)  1/116 (0.86%) 
Duodenal ulcer haemorrage  1  0/115 (0.00%)  1/116 (0.86%) 
Enteritis  1  0/115 (0.00%)  1/116 (0.86%) 
Food poisoning  1  0/115 (0.00%)  1/116 (0.86%) 
Gastric ulcer  1  1/115 (0.87%)  0/116 (0.00%) 
Gastric ulcer haemorrhage  1  1/115 (0.87%)  0/116 (0.00%) 
Gastric varices haemorrhage  1  0/115 (0.00%)  1/116 (0.86%) 
Gastrointestinal haemorrhage  1  3/115 (2.61%)  5/116 (4.31%) 
Gastrooesophageal reflux disease  1  1/115 (0.87%)  0/116 (0.00%) 
Haematemesis  1  0/115 (0.00%)  1/116 (0.86%) 
Haemorrhoidal haemorrhage  1  0/115 (0.00%)  1/116 (0.86%) 
Inguinal hernia  1  3/115 (2.61%)  1/116 (0.86%) 
Oesophageal varices haemorrhage  1  7/115 (6.09%)  3/116 (2.59%) 
Pancreatitis acute  1  1/115 (0.87%)  0/116 (0.00%) 
Periodontitis  1  0/115 (0.00%)  1/116 (0.86%) 
Umbilical hernia  1  2/115 (1.74%)  0/116 (0.00%) 
Upper gastrointestinal haemorrhage  1  1/115 (0.87%)  0/116 (0.00%) 
Varices oesophageal  1  0/115 (0.00%)  1/116 (0.86%) 
Vomiting  1  1/115 (0.87%)  1/116 (0.86%) 
General disorders     
Death  1  0/115 (0.00%)  1/116 (0.86%) 
Fatigue  1  1/115 (0.87%)  1/116 (0.86%) 
Hernia  1  0/115 (0.00%)  1/116 (0.86%) 
Oedema peripheral  1  1/115 (0.87%)  1/116 (0.86%) 
Pitting oedema  1  1/115 (0.87%)  0/116 (0.00%) 
Pyrexia  1  0/115 (0.00%)  1/116 (0.86%) 
Hepatobiliary disorders     
Biloma  1  0/115 (0.00%)  1/116 (0.86%) 
Cholangitis  1  1/115 (0.87%)  0/116 (0.00%) 
Cholecystitis chronic  1  0/115 (0.00%)  1/116 (0.86%) 
Hepatic cirrhosis  1  1/115 (0.87%)  2/116 (1.72%) 
Hepatic dysplasia  1  1/115 (0.87%)  0/116 (0.00%) 
Hepatic failure  1  1/115 (0.87%)  2/116 (1.72%) 
Hepatorenal syndrome  1  3/115 (2.61%)  1/116 (0.86%) 
Jaundice  1  1/115 (0.87%)  1/116 (0.86%) 
Jaundice cholestatic  1  0/115 (0.00%)  1/116 (0.86%) 
Liver disorder  1  0/115 (0.00%)  1/116 (0.86%) 
Infections and infestations     
Arthritis bacterial  1  0/115 (0.00%)  2/116 (1.72%) 
Bacteraemia  1  1/115 (0.87%)  1/116 (0.86%) 
Bronchitis acute  1  0/115 (0.00%)  1/116 (0.86%) 
Cellulitis  1  5/115 (4.35%)  1/116 (0.86%) 
Dental caries  1  0/115 (0.00%)  1/116 (0.86%) 
Gastroenteritis  1  2/115 (1.74%)  4/116 (3.45%) 
Hepatitis B  1  0/115 (0.00%)  2/116 (1.72%) 
Necrostising fasciitis  1  0/115 (0.00%)  1/116 (0.86%) 
Otitis media chronic  1  1/115 (0.87%)  0/116 (0.00%) 
Peritonitis bacterial  1  8/115 (6.96%)  7/116 (6.03%) 
Pneumonia  1  1/115 (0.87%)  3/116 (2.59%) 
Pulmonary tuberculosis  1  0/115 (0.00%)  1/116 (0.86%) 
Pyelonephritis acute  1  1/115 (0.87%)  0/116 (0.00%) 
Sepsis  1  8/115 (6.96%)  0/116 (0.00%) 
Septic shock  1  3/115 (2.61%)  1/116 (0.86%) 
Staphylococcal infection  1  1/115 (0.87%)  0/116 (0.00%) 
Subdiaphragmatic abscess  1  1/115 (0.87%)  0/116 (0.00%) 
Urinary tract infection  1  2/115 (1.74%)  3/116 (2.59%) 
Viral infection  1  0/115 (0.00%)  1/116 (0.86%) 
Injury, poisoning and procedural complications     
Comminuted fracture  1  1/115 (0.87%)  0/116 (0.00%) 
Post procedural haemorrhage  1  1/115 (0.87%)  0/116 (0.00%) 
Investigations     
Alpha 1 foetoprotein increased  1  0/115 (0.00%)  1/116 (0.86%) 
Ammonia increased  1  1/115 (0.87%)  0/116 (0.00%) 
Blood creatine phosphikinase increased  1  0/115 (0.00%)  1/116 (0.86%) 
Blood pressure systolic  1  0/115 (0.00%)  1/116 (0.86%) 
Transplant evaluation  1  0/115 (0.00%)  1/116 (0.86%) 
Viral load increased  1  0/115 (0.00%)  1/116 (0.86%) 
Metabolism and nutrition disorders     
Dehydration  1  1/115 (0.87%)  2/116 (1.72%) 
Diabetes mellitus  1  1/115 (0.87%)  0/116 (0.00%) 
Diabetes mellitus inadequate control  1  0/115 (0.00%)  1/116 (0.86%) 
Hyperglycaemia  1  0/115 (0.00%)  3/116 (2.59%) 
Hypoglycaemia  1  0/115 (0.00%)  1/116 (0.86%) 
Hyponatraemia  1  1/115 (0.87%)  0/116 (0.00%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  0/115 (0.00%)  1/116 (0.86%) 
Fracture nonunion  1  0/115 (0.00%)  1/116 (0.86%) 
Myopathy  1  1/115 (0.87%)  0/116 (0.00%) 
Pain in extremity  1  1/115 (0.87%)  0/116 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Gastric cancer  1  0/115 (0.00%)  1/116 (0.86%) 
Hepatic neoplasm  1  1/115 (0.87%)  0/116 (0.00%) 
Hepatic neoplasm malignant  1  10/115 (8.70%)  12/116 (10.34%) 
Nervous system disorders     
Cerebellar infarction  1  1/115 (0.87%)  0/116 (0.00%) 
Cerebral haemorrhage  1  1/115 (0.87%)  0/116 (0.00%) 
Coma hepatic  1  0/115 (0.00%)  1/116 (0.86%) 
Depressed level of consciousness  1  0/115 (0.00%)  2/116 (1.72%) 
Encephalopathy  1  3/115 (2.61%)  2/116 (1.72%) 
Hemiparesis  1  0/115 (0.00%)  1/116 (0.86%) 
Hepatic encephalopathy  1  15/115 (13.04%)  13/116 (11.21%) 
Renal and urinary disorders     
Obstructive uropathy  1  1/115 (0.87%)  0/116 (0.00%) 
Reproductive system and breast disorders     
Benign prostatic hyperplasia  1  1/115 (0.87%)  0/116 (0.00%) 
Postmenopausal haemorrhage  1  1/115 (0.87%)  0/116 (0.00%) 
Proststitis  1  2/115 (1.74%)  0/116 (0.00%) 
Uterine polyp  1  0/115 (0.00%)  1/116 (0.86%) 
Vaginal Prolapse  1  0/115 (0.00%)  1/116 (0.86%) 
Respiratory, thoracic and mediastinal disorders     
Chronic obstructive airways disease  1  1/115 (0.87%)  0/116 (0.00%) 
Epistaxis  1  1/115 (0.87%)  0/116 (0.00%) 
Hydropneumothorax  1  0/115 (0.00%)  1/116 (0.86%) 
Hydrothorax  1  1/115 (0.87%)  0/116 (0.00%) 
Pleural effusion  1  5/115 (4.35%)  4/116 (3.45%) 
Pneumonia aspiration  1  1/115 (0.87%)  0/116 (0.00%) 
Surgical and medical procedures     
Haemorrhoid operation  1  0/115 (0.00%)  1/116 (0.86%) 
Vascular disorders     
Arteriosclerosis  1  0/115 (0.00%)  1/116 (0.86%) 
Haemorrhage  1  0/115 (0.00%)  1/116 (0.86%) 
Hypotension  1  0/115 (0.00%)  1/116 (0.86%) 
Hypovolaemic shock  1  0/115 (0.00%)  1/116 (0.86%) 
Orthostatic hypotension  1  0/115 (0.00%)  1/116 (0.86%) 
Shock  1  2/115 (1.74%)  0/116 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Telbivudine 600 mg Lamivudine 100 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   99/115 (86.09%)   97/116 (83.62%) 
Blood and lymphatic system disorders     
Anaemia  1  6/115 (5.22%)  7/116 (6.03%) 
Splenomegaly  1  6/115 (5.22%)  7/116 (6.03%) 
Gastrointestinal disorders     
Abdominal discomfort  1  3/115 (2.61%)  10/116 (8.62%) 
Abdominal distension  1  23/115 (20.00%)  14/116 (12.07%) 
Abdominal pain  1  12/115 (10.43%)  14/116 (12.07%) 
Abdominal pain upper  1  6/115 (5.22%)  10/116 (8.62%) 
Ascites  1  40/115 (34.78%)  41/116 (35.34%) 
Constipation  1  9/115 (7.83%)  9/116 (7.76%) 
Diarrhoea  1  15/115 (13.04%)  16/116 (13.79%) 
Dyspepsia  1  15/115 (13.04%)  12/116 (10.34%) 
Nausea  1  10/115 (8.70%)  7/116 (6.03%) 
Varices Oesophageal  1  6/115 (5.22%)  4/116 (3.45%) 
Vomiting  1  8/115 (6.96%)  3/116 (2.59%) 
General disorders     
Asthenia  1  5/115 (4.35%)  12/116 (10.34%) 
Fatigue  1  16/115 (13.91%)  14/116 (12.07%) 
Oedema peripheral  1  33/115 (28.70%)  21/116 (18.10%) 
Pitting oedema  1  13/115 (11.30%)  12/116 (10.34%) 
Pyrexia  1  20/115 (17.39%)  17/116 (14.66%) 
Hepatobiliary disorders     
Jaundice  1  15/115 (13.04%)  11/116 (9.48%) 
Infections and infestations     
Nasopharyngitis  1  5/115 (4.35%)  9/116 (7.76%) 
Upper respiratory tract infection  1  17/115 (14.78%)  12/116 (10.34%) 
Investigations     
Blood creatine phosphokinase increased  1  7/115 (6.09%)  2/116 (1.72%) 
Metabolism and nutrition disorders     
Anorexia  1  6/115 (5.22%)  3/116 (2.59%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  7/115 (6.09%)  10/116 (8.62%) 
Back pain  1  10/115 (8.70%)  8/116 (6.90%) 
Muscle cramp  1  6/115 (5.22%)  7/116 (6.03%) 
Pain in extremity  1  6/115 (5.22%)  5/116 (4.31%) 
Nervous system disorders     
Dizziness  1  7/115 (6.09%)  9/116 (7.76%) 
Encephalopathy  1  6/115 (5.22%)  6/116 (5.17%) 
Headache  1  8/115 (6.96%)  11/116 (9.48%) 
Hepatic Encephalopathy  1  7/115 (6.09%)  7/116 (6.03%) 
Psychiatric disorders     
Insomnia  1  11/115 (9.57%)  9/116 (7.76%) 
Reproductive system and breast disorders     
Gynaecomastia  1  16/115 (13.91%)  19/116 (16.38%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  17/115 (14.78%)  8/116 (6.90%) 
Dyspnoea  1  6/115 (5.22%)  5/116 (4.31%) 
Epistaxis  1  7/115 (6.09%)  4/116 (3.45%) 
Skin and subcutaneous tissue disorders     
Pruritus  1  10/115 (8.70%)  12/116 (10.34%) 
Spider Naevus  1  6/115 (5.22%)  2/116 (1.72%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
Phone: 862-778-8300
Publications of Results:
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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Responsible Party: External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00076336     History of Changes
Other Study ID Numbers: CLDT600A2301
First Submitted: January 20, 2004
First Posted: January 22, 2004
Results First Submitted: January 3, 2011
Results First Posted: September 5, 2011
Last Update Posted: September 5, 2011