Trial Outcomes & Findings for Study of Efficacy and Safety, Tolerability and Pharmacokinetics of Telbivudine in Children and Adolescents With Compensated Chronic Hepatitis B Virus Infection (NCT NCT02058108)

NCT ID: NCT02058108

Last Updated: 2019-09-10

Results Overview

The primary objective of this study was to demonstrate the antiviral efficacy of telbivudine compared to placebo in pediatric patients (2- \< 18 years) by determining the percentage of patients achieving serum HBV DNA level of \<300 copies/mL (51 IU/mL) at Week 24.

• Recruitment status: TERMINATED
• Study phase: PHASE3
• Target enrollment: 53 participants
• Primary outcome timeframe: Week 24
• Results posted on: 2019-09-10

Participant Flow

This study was conducted in 20 centers in 7 countries: Bulgaria (2), Greece (1), Israel (2), Republic of Korea (1), Romania (5), Turkey (4) and Ukraine (5 sites).

Patients were stratified by age group (2 to < 6 years, 6 to <12 years and 12 to <18 years) and HBV DNA level (low and high). At the baseline visit, eligible patients were randomized in a 24-week double blind period to telbivudine or placebo in a ratio 5:1. At Week 24 (visit 6), all patients were unblinded and HBV DNA level were assessed.

Participant milestones

Measure	Telbivudine Patients of any age and weight\< 30kg: telbivudine oral solution (20 mg/mL): 20 mg/kg up to 600 mg q.d corresponding to weight (kg) x1mL, p.o. once daily Patients \< 12 years old and weight≥ 30kg: telbivudine oral solution (20mg/mL), 600 mg/day corresponding to 30 mL p.o. once daily Patients ≥ 12 years old and weight ≥ 30kg: telbivudine film-coated tablet, 600 mg/day, corresponding to 1 tablet p.o. once daily	Placebo Patients of any age and weight \< 30kg: placebo oral solution corresponding to weight (kg) x1mL, p.o. once daily Patients \< 12 years old and weight ≥ 30kg: placebo oral solution corresponding to 30 mL p.o. once daily Patients ≥ 12 years old and weight ≥ 30kg: placebo tablet, corresponding to 1 tablet p.o. once daily. Placebo randomized patients were offered optional telbivudine administration at week 24.
Overall Study STARTED	43	10
Overall Study Switched to Telbivudine After Week 24	0	5
Overall Study COMPLETED	2	0
Overall Study NOT COMPLETED	41	10

Reasons for withdrawal

Measure	Telbivudine Patients of any age and weight\< 30kg: telbivudine oral solution (20 mg/mL): 20 mg/kg up to 600 mg q.d corresponding to weight (kg) x1mL, p.o. once daily Patients \< 12 years old and weight≥ 30kg: telbivudine oral solution (20mg/mL), 600 mg/day corresponding to 30 mL p.o. once daily Patients ≥ 12 years old and weight ≥ 30kg: telbivudine film-coated tablet, 600 mg/day, corresponding to 1 tablet p.o. once daily	Placebo Patients of any age and weight \< 30kg: placebo oral solution corresponding to weight (kg) x1mL, p.o. once daily Patients \< 12 years old and weight ≥ 30kg: placebo oral solution corresponding to 30 mL p.o. once daily Patients ≥ 12 years old and weight ≥ 30kg: placebo tablet, corresponding to 1 tablet p.o. once daily. Placebo randomized patients were offered optional telbivudine administration at week 24.
Overall Study Abnormal Laboratory Values	0	1
Overall Study Unsatisfactory therapeutic effect	37	4
Overall Study No longer requires study drug	0	1
Overall Study Withdrawal by Subject	1	0
Overall Study Administrative problems	3	3
Overall Study Protocol Violation	0	1

Baseline Characteristics

Study of Efficacy and Safety, Tolerability and Pharmacokinetics of Telbivudine in Children and Adolescents With Compensated Chronic Hepatitis B Virus Infection

Baseline characteristics by cohort

Measure	Telbivudine n=43 Participants Patients of any age and weight\< 30kg: telbivudine oral solution (20 mg/mL): 20 mg/kg up to 600 mg q.d corresponding to weight (kg) x1mL, p.o. once daily Patients \< 12 years old and weight≥ 30kg: telbivudine oral solution (20mg/mL), 600 mg/day corresponding to 30 mL p.o. once daily Patients ≥ 12 years old and weight ≥ 30kg: telbivudine film-coated tablet, 600 mg/day, corresponding to 1 tablet p.o. once daily	Placebo n=10 Participants Patients of any age and weight \< 30kg: placebo oral solution corresponding to weight (kg) x1mL, p.o. once daily Patients \< 12 years old and weight ≥ 30kg: placebo oral solution corresponding to 30 mL p.o. once daily Patients ≥ 12 years old and weight ≥ 30kg: placebo tablet, corresponding to 1 tablet p.o. once daily. Placebo randomized patients were offered optional telbivudine administration at week 24.	Total n=53 Participants Total of all reporting groups
Age, Continuous	10.2 Years STANDARD_DEVIATION 4.88 • n=5 Participants	9.1 Years STANDARD_DEVIATION 4.89 • n=7 Participants	10.0 Years STANDARD_DEVIATION 4.86 • n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants	4 Participants n=7 Participants	18 Participants n=5 Participants
Sex: Female, Male Male	29 Participants n=5 Participants	6 Participants n=7 Participants	35 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	40 Participants n=5 Participants	10 Participants n=7 Participants	50 Participants n=5 Participants
Race/Ethnicity, Customized Black	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Asian	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
HBV DNA	9.1 log10 copies/mL STANDARD_DEVIATION 1.14 • n=5 Participants	8.2 log10 copies/mL STANDARD_DEVIATION 2.26 • n=7 Participants	8.9 log10 copies/mL STANDARD_DEVIATION 1.43 • n=5 Participants
Participants with alanine aminotransferase (ALT) - Multiples of upper limits of normal (ULN) < 1 × ULN	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Participants with alanine aminotransferase (ALT) - Multiples of upper limits of normal (ULN) 1 × - < 2 × ULN	22 Participants n=5 Participants	4 Participants n=7 Participants	26 Participants n=5 Participants
Participants with alanine aminotransferase (ALT) - Multiples of upper limits of normal (ULN) 2 × - < 5 × ULN	16 Participants n=5 Participants	2 Participants n=7 Participants	18 Participants n=5 Participants
Participants with alanine aminotransferase (ALT) - Multiples of upper limits of normal (ULN) 5 × or more ULN	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Participants with aspartate aminotransferase (AST) - Multiples of upper limits of normal (ULN) < 1 × ULN	26 Participants n=5 Participants	5 Participants n=7 Participants	31 Participants n=5 Participants
Participants with aspartate aminotransferase (AST) - Multiples of upper limits of normal (ULN) 1 × - < 2 × ULN	14 Participants n=5 Participants	4 Participants n=7 Participants	18 Participants n=5 Participants
Participants with aspartate aminotransferase (AST) - Multiples of upper limits of normal (ULN) 2 × - < 5 × ULN	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Participants with aspartate aminotransferase (AST) - Multiples of upper limits of normal (ULN) 5 × or more ULN	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: Week 24

Population: The Full Analysis Set (FAS), which consisted of all randomized patients to whom study treatment had been assigned, was considered.

The primary objective of this study was to demonstrate the antiviral efficacy of telbivudine compared to placebo in pediatric patients (2- < 18 years) by determining the percentage of patients achieving serum HBV DNA level of <300 copies/mL (51 IU/mL) at Week 24.

Outcome measures

Measure	Telbivudine n=41 Participants Patients of any age and weight\< 30kg: telbivudine oral solution (20 mg/mL): 20 mg/kg up to 600 mg q.d corresponding to weight (kg) x1mL, p.o. once daily Patients \< 12 years old and weight≥ 30kg: telbivudine oral solution (20mg/mL), 600 mg/day corresponding to 30 mL p.o. once daily Patients ≥ 12 years old and weight ≥ 30kg: telbivudine film-coated tablet, 600 mg/day, corresponding to 1 tablet p.o. once daily	Placebo n=8 Participants Patients of any age and weight \< 30kg: placebo oral solution corresponding to weight (kg) x1mL, p.o. once daily Patients \< 12 years old and weight ≥ 30kg: placebo oral solution corresponding to 30 mL p.o. once daily Patients ≥ 12 years old and weight ≥ 30kg: placebo tablet, corresponding to 1 tablet p.o. once daily. Placebo randomized patients were offered optional telbivudine administration at week 24.
Number of Patients Achieving Serum HBV DNA Level of <300 Copies/mL (51 IU/mL) at Week 24	5 Participants	1 Participants

SECONDARY outcome

Timeframe: Week 52, Week 104

Population: The Full Analysis Set (FAS), which consisted of all randomized patients to whom study treatment had been assigned, was considered. Only patients with efficacy data within censoring date included in the analysis.

The antiviral efficacy at Weeks 52 and 104 was to be evaluated by: a) the proportion of patients achieving HBV DNA <300 copies/mL (51 IU/mL) at Week 52 and Week 104; b) the proportion of patients achieving HBV DNA < Lower Limit of Quantification (LLOQ), <1000 copies/ml (or 200 IU/mL), <10,000 copies/ml (or 2 000 IU/mL) and ≥10,000 copies/mL (or 2 000 IU/mL) at Week 24, 52 and 104; c) the proportion of patients achieving Serum HBV DNA reduction from baseline; d) the time to achieve HBV DNA <300 copies/mL (51 IU/mL); e) the proportion of patients with Primary non-response.

Due to early termination of the study and limited number of enrolled patients on track to complete 52 weeks of participation (8 patients overall), only descriptive analysis performed at Week 52 and Week 104.

Outcome measures

Measure	Telbivudine n=3 Participants Patients of any age and weight\< 30kg: telbivudine oral solution (20 mg/mL): 20 mg/kg up to 600 mg q.d corresponding to weight (kg) x1mL, p.o. once daily Patients \< 12 years old and weight≥ 30kg: telbivudine oral solution (20mg/mL), 600 mg/day corresponding to 30 mL p.o. once daily Patients ≥ 12 years old and weight ≥ 30kg: telbivudine film-coated tablet, 600 mg/day, corresponding to 1 tablet p.o. once daily	Placebo n=3 Participants Patients of any age and weight \< 30kg: placebo oral solution corresponding to weight (kg) x1mL, p.o. once daily Patients \< 12 years old and weight ≥ 30kg: placebo oral solution corresponding to 30 mL p.o. once daily Patients ≥ 12 years old and weight ≥ 30kg: placebo tablet, corresponding to 1 tablet p.o. once daily. Placebo randomized patients were offered optional telbivudine administration at week 24.
Number of Patients Achieving HBV DNA< 300 Copies/mL (51 IU/mL) at Week 52 and Week 104 Week 52	3 Participants	0 Participants
Number of Patients Achieving HBV DNA< 300 Copies/mL (51 IU/mL) at Week 52 and Week 104 Week 104	2 Participants	—

SECONDARY outcome

Timeframe: Week 24, Week 52, Week 104

Population: The Full Analysis Set (FAS), which consisted of all randomized patients to whom study treatment had been assigned, was considered. Only patients with efficacy data within censoring date included in the analysis.

The biochemical response at Weeks 24, 52 and 104 was to be evaluated by the proportion of patients whose baseline ALTs were abnormal (defined as ALT >1 x Upper Limit of Normal [ULN]) and subsequently normalized.

Due to early termination of the study and limited number of enrolled patients on track to complete 52 weeks of participation (8 patients overall), only descriptive analysis performed at Week 52 and Week 104.

Outcome measures

Measure	Telbivudine n=37 Participants Patients of any age and weight\< 30kg: telbivudine oral solution (20 mg/mL): 20 mg/kg up to 600 mg q.d corresponding to weight (kg) x1mL, p.o. once daily Patients \< 12 years old and weight≥ 30kg: telbivudine oral solution (20mg/mL), 600 mg/day corresponding to 30 mL p.o. once daily Patients ≥ 12 years old and weight ≥ 30kg: telbivudine film-coated tablet, 600 mg/day, corresponding to 1 tablet p.o. once daily	Placebo n=5 Participants Patients of any age and weight \< 30kg: placebo oral solution corresponding to weight (kg) x1mL, p.o. once daily Patients \< 12 years old and weight ≥ 30kg: placebo oral solution corresponding to 30 mL p.o. once daily Patients ≥ 12 years old and weight ≥ 30kg: placebo tablet, corresponding to 1 tablet p.o. once daily. Placebo randomized patients were offered optional telbivudine administration at week 24.
Number of Patients Whose Baseline ALTs Were Abnormal and Subsequently Normalized at Week 24, 52 and 104 Week 24	12 Participants	0 Participants
Number of Patients Whose Baseline ALTs Were Abnormal and Subsequently Normalized at Week 24, 52 and 104 Week 52	1 Participants	1 Participants
Number of Patients Whose Baseline ALTs Were Abnormal and Subsequently Normalized at Week 24, 52 and 104 Week 104	2 Participants	—

SECONDARY outcome

Timeframe: Week 24, Week 52, Week 104

Population: The Full Analysis Set (FAS), which consisted of all randomized patients to whom study treatment had been assigned, was considered. Only patients with efficacy data within censoring date included in the analysis.

The serological response at Weeks 24, 52 and 104 was to be evaluated by: a) the proportion of HBeAg positive patients at baseline who subsequently have HBeAg loss and HBeAg seroconversion (defined as loss of HBeAg with detectable HBeAb); b) the proportion of HBsAg positive patients at baseline who subsequently have HBsAg loss and HBsAg seroconversion (defined as loss of HBsAg with detectable HBsAb).

Due to early termination of the study and limited number of enrolled patients on track to complete 52 weeks of participation (8 patients overall), only descriptive analysis performed at Week 52 and Week 104.

Outcome measures

Measure	Telbivudine n=37 Participants Patients of any age and weight\< 30kg: telbivudine oral solution (20 mg/mL): 20 mg/kg up to 600 mg q.d corresponding to weight (kg) x1mL, p.o. once daily Patients \< 12 years old and weight≥ 30kg: telbivudine oral solution (20mg/mL), 600 mg/day corresponding to 30 mL p.o. once daily Patients ≥ 12 years old and weight ≥ 30kg: telbivudine film-coated tablet, 600 mg/day, corresponding to 1 tablet p.o. once daily	Placebo n=4 Participants Patients of any age and weight \< 30kg: placebo oral solution corresponding to weight (kg) x1mL, p.o. once daily Patients \< 12 years old and weight ≥ 30kg: placebo oral solution corresponding to 30 mL p.o. once daily Patients ≥ 12 years old and weight ≥ 30kg: placebo tablet, corresponding to 1 tablet p.o. once daily. Placebo randomized patients were offered optional telbivudine administration at week 24.
Number of Patients With HBeAg Loss, HBeAg Seroconversion at Week 24, 52 and 104 HBeAg loss at Week 24	1 Participants	0 Participants
Number of Patients With HBeAg Loss, HBeAg Seroconversion at Week 24, 52 and 104 HBeAg seroconversion at Week 24	1 Participants	0 Participants
Number of Patients With HBeAg Loss, HBeAg Seroconversion at Week 24, 52 and 104 HBeAg loss at Week 52	1 Participants	0 Participants
Number of Patients With HBeAg Loss, HBeAg Seroconversion at Week 24, 52 and 104 HBeAg seroconversion at Week 52	1 Participants	0 Participants
Number of Patients With HBeAg Loss, HBeAg Seroconversion at Week 24, 52 and 104 HBeAg loss at Week 104	1 Participants	—
Number of Patients With HBeAg Loss, HBeAg Seroconversion at Week 24, 52 and 104 HBeAg seroconversion at Week 104	1 Participants	—

SECONDARY outcome

Timeframe: Week 24, Week 52, Week 104

Population: The Full Analysis Set (FAS), which consisted of all randomized patients to whom study treatment had been assigned, was considered. Only patients with efficacy data within censoring date included in the analysis.

The serological response at Weeks 24, 52 and 104 was to be evaluated by: a) the proportion of HBeAg positive patients at baseline who subsequently have HBeAg loss and HBeAg seroconversion (defined as loss of HBeAg with detectable HBeAb); b) the proportion of HBsAg positive patients at baseline who subsequently have HBsAg loss and HBsAg seroconversion (defined as loss of HBsAg with detectable HBsAb).

Due to early termination of the study and limited number of enrolled patients on track to complete 52 weeks of participation (8 patients overall), only descriptive analysis performed at Week 52 and Week 104.

Outcome measures

Measure	Telbivudine n=41 Participants Patients of any age and weight\< 30kg: telbivudine oral solution (20 mg/mL): 20 mg/kg up to 600 mg q.d corresponding to weight (kg) x1mL, p.o. once daily Patients \< 12 years old and weight≥ 30kg: telbivudine oral solution (20mg/mL), 600 mg/day corresponding to 30 mL p.o. once daily Patients ≥ 12 years old and weight ≥ 30kg: telbivudine film-coated tablet, 600 mg/day, corresponding to 1 tablet p.o. once daily	Placebo n=7 Participants Patients of any age and weight \< 30kg: placebo oral solution corresponding to weight (kg) x1mL, p.o. once daily Patients \< 12 years old and weight ≥ 30kg: placebo oral solution corresponding to 30 mL p.o. once daily Patients ≥ 12 years old and weight ≥ 30kg: placebo tablet, corresponding to 1 tablet p.o. once daily. Placebo randomized patients were offered optional telbivudine administration at week 24.
Number of Patients With HBsAg Loss, HBsAg Seroconversion at Week 24, 52 and 104 HBsAg loss at Week 24	1 Participants	0 Participants
Number of Patients With HBsAg Loss, HBsAg Seroconversion at Week 24, 52 and 104 HBsAg seroconversion at Week 24	0 Participants	0 Participants
Number of Patients With HBsAg Loss, HBsAg Seroconversion at Week 24, 52 and 104 HBsAg loss at Week 52	0 Participants	0 Participants
Number of Patients With HBsAg Loss, HBsAg Seroconversion at Week 24, 52 and 104 HBsAg seroconversion at Week 52	0 Participants	0 Participants
Number of Patients With HBsAg Loss, HBsAg Seroconversion at Week 24, 52 and 104 HBsAg loss at Week 104	0 Participants	—
Number of Patients With HBsAg Loss, HBsAg Seroconversion at Week 24, 52 and 104 HBsAg seroconversion at Week 104	0 Participants	—

SECONDARY outcome

Timeframe: Week 52, Week 104

Population: The Full Analysis Set (FAS), which consisted of all randomized patients to whom study treatment had been assigned, was considered. Only patients with efficacy data within censoring date included in the analysis.

The proportion of patients achieving composite endpoints at Week 52 and 104 was to be evaluated by the proportion of patients achieving: a) HBV DNA <300 copies/mL (51 IU/mL); b) ALT normalization and HBeAg seroconversion for HBeAg positive patients only; c) HBV DNA <300 copies/mL (51 IU/mL) and ALT normalization for HBeAg negative patients.

Due to early termination of the study and limited number of enrolled patients on track to complete 52 weeks of participation (8 patients overall), only descriptive analysis performed at Week 52 and Week 104.

Outcome measures

Measure	Telbivudine n=3 Participants Patients of any age and weight\< 30kg: telbivudine oral solution (20 mg/mL): 20 mg/kg up to 600 mg q.d corresponding to weight (kg) x1mL, p.o. once daily Patients \< 12 years old and weight≥ 30kg: telbivudine oral solution (20mg/mL), 600 mg/day corresponding to 30 mL p.o. once daily Patients ≥ 12 years old and weight ≥ 30kg: telbivudine film-coated tablet, 600 mg/day, corresponding to 1 tablet p.o. once daily	Placebo n=3 Participants Patients of any age and weight \< 30kg: placebo oral solution corresponding to weight (kg) x1mL, p.o. once daily Patients \< 12 years old and weight ≥ 30kg: placebo oral solution corresponding to 30 mL p.o. once daily Patients ≥ 12 years old and weight ≥ 30kg: placebo tablet, corresponding to 1 tablet p.o. once daily. Placebo randomized patients were offered optional telbivudine administration at week 24.
Number of Patients Achieving a Composite Endpoints (HBV DNA < 300 Copies/mL (51 IU/mL), ALT Normalization and HBeAg Seroconversion) at Week 52 and 104 Week 52	1 Participants	0 Participants
Number of Patients Achieving a Composite Endpoints (HBV DNA < 300 Copies/mL (51 IU/mL), ALT Normalization and HBeAg Seroconversion) at Week 52 and 104 Week 104	1 Participants	—

SECONDARY outcome

Timeframe: Week 52, Week 104

Population: The Full Analysis Set (FAS), which consisted of all randomized patients to whom study treatment had been assigned, was considered. Only patients with efficacy data within censoring date included in the analysis.

The assessment of virological breakthrough (VB) was to be evaluated by: a) the cumulative rate of patients with confirmed VB at Week 52 and Week 104; b) the time to VB.

Due to early termination of the study and limited number of enrolled patients on track to complete 52 weeks of participation (8 patients overall), only descriptive analysis performed at Week 52 and Week 104.

Outcome measures

Measure	Telbivudine n=41 Participants Patients of any age and weight\< 30kg: telbivudine oral solution (20 mg/mL): 20 mg/kg up to 600 mg q.d corresponding to weight (kg) x1mL, p.o. once daily Patients \< 12 years old and weight≥ 30kg: telbivudine oral solution (20mg/mL), 600 mg/day corresponding to 30 mL p.o. once daily Patients ≥ 12 years old and weight ≥ 30kg: telbivudine film-coated tablet, 600 mg/day, corresponding to 1 tablet p.o. once daily	Placebo n=8 Participants Patients of any age and weight \< 30kg: placebo oral solution corresponding to weight (kg) x1mL, p.o. once daily Patients \< 12 years old and weight ≥ 30kg: placebo oral solution corresponding to 30 mL p.o. once daily Patients ≥ 12 years old and weight ≥ 30kg: placebo tablet, corresponding to 1 tablet p.o. once daily. Placebo randomized patients were offered optional telbivudine administration at week 24.
Number of Patients Achieving Cumulative Rate of Virological Breakthrough (VB) at Week 52 and 104 Week 52	1 Participants	0 Participants
Number of Patients Achieving Cumulative Rate of Virological Breakthrough (VB) at Week 52 and 104 Week 104	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Week 24

Population: The Full Analysis Set (FAS), which consisted of all randomized patients to whom study treatment had been assigned, was considered. Only patients with efficacy data within censoring date included in the analysis.

Assessment of the presence of treatment emergent genotypic resistance (confirmed by genotypic sequencing) associated with virological breakthrough over the study period, or in patients with HBV DNA≥300 copies/mL (51 IU/mL) at Week 24 and discontinued from the study treatment (or at discontinuation if prior to Week 24 for subjects with at least 16 weeks of LDT treatment)

Outcome measures

Measure	Telbivudine n=41 Participants Patients of any age and weight\< 30kg: telbivudine oral solution (20 mg/mL): 20 mg/kg up to 600 mg q.d corresponding to weight (kg) x1mL, p.o. once daily Patients \< 12 years old and weight≥ 30kg: telbivudine oral solution (20mg/mL), 600 mg/day corresponding to 30 mL p.o. once daily Patients ≥ 12 years old and weight ≥ 30kg: telbivudine film-coated tablet, 600 mg/day, corresponding to 1 tablet p.o. once daily	Placebo n=8 Participants Patients of any age and weight \< 30kg: placebo oral solution corresponding to weight (kg) x1mL, p.o. once daily Patients \< 12 years old and weight ≥ 30kg: placebo oral solution corresponding to 30 mL p.o. once daily Patients ≥ 12 years old and weight ≥ 30kg: placebo tablet, corresponding to 1 tablet p.o. once daily. Placebo randomized patients were offered optional telbivudine administration at week 24.
Number of Participants With Treatment Emergent Genotypic Resistance Associated With VB, or in Patients With HBV DNA≥300 Copies/mL (51 IU/mL) at Week 24 and Discontinued From the Study Cumulative virological breakthrough	0 Participants	0 Participants
Number of Participants With Treatment Emergent Genotypic Resistance Associated With VB, or in Patients With HBV DNA≥300 Copies/mL (51 IU/mL) at Week 24 and Discontinued From the Study Cumulative treatment emergent genotypic resistance	1 Participants	0 Participants

SECONDARY outcome

Timeframe: From first dose of study treatment to 30 days after last dose of study treatment, up to 112 weeks

Population: The Safety Set, which consisted of all patients who received at least one dose of study drug during the treatment period, was considered.

Evaluation of the safety and tolerability of Telbivudine defined by AEs, SAEs, adverse events of special interest (AESI) (including muscle related events) and death; laboratory evaluations specifically on-treatment and post-treatment ALT flares, incidence and clinical significance of CK elevations; growth and development (linear growth and sexual maturation); development of liver decompensation and/or HCC.

Only descriptive analysis performed.

Outcome measures

Measure	Telbivudine n=43 Participants Patients of any age and weight\< 30kg: telbivudine oral solution (20 mg/mL): 20 mg/kg up to 600 mg q.d corresponding to weight (kg) x1mL, p.o. once daily Patients \< 12 years old and weight≥ 30kg: telbivudine oral solution (20mg/mL), 600 mg/day corresponding to 30 mL p.o. once daily Patients ≥ 12 years old and weight ≥ 30kg: telbivudine film-coated tablet, 600 mg/day, corresponding to 1 tablet p.o. once daily	Placebo n=10 Participants Patients of any age and weight \< 30kg: placebo oral solution corresponding to weight (kg) x1mL, p.o. once daily Patients \< 12 years old and weight ≥ 30kg: placebo oral solution corresponding to 30 mL p.o. once daily Patients ≥ 12 years old and weight ≥ 30kg: placebo tablet, corresponding to 1 tablet p.o. once daily. Placebo randomized patients were offered optional telbivudine administration at week 24.
Number of Participants With On-Treatments Adverse Events, Serious Adverse Events, and Death On-treatment Adverse Event (AEs)	20 Participants	4 Participants
Number of Participants With On-Treatments Adverse Events, Serious Adverse Events, and Death On-treatment Serious Adverse Event (SAEs)	0 Participants	0 Participants
Number of Participants With On-Treatments Adverse Events, Serious Adverse Events, and Death On-treatment Deaths	0 Participants	0 Participants

Adverse Events

Initial LdT (Telbivudine)

Serious events: 0 serious events

Other events: 20 other events

Deaths: 0 deaths

Initial Placebo on Placebo Treatment

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Initial Placebo on LdT Treatment After Switching

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

All Ldt

Serious events: 0 serious events

Other events: 21 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Initial LdT (Telbivudine) n=43 participants at risk Patients of any age and weight\< 30kg: telbivudine oral solution (20 mg/mL): 20 mg/kg up to 600 mg q.d corresponding to weight (kg) x1mL, p.o. once daily Patients \< 12 years old and weight≥ 30kg: telbivudine oral solution (20mg/mL), 600 mg/day corresponding to 30 mL p.o. once daily Patients ≥ 12 years old and weight ≥ 30kg: telbivudine film-coated tablet, 600 mg/day, corresponding to 1 tablet p.o. once daily	Initial Placebo on Placebo Treatment n=10 participants at risk Initial Placebo patients who did not switched to LdT treatment	Initial Placebo on LdT Treatment After Switching n=5 participants at risk Initial Placebo patients who switched to LdT treatment	All Ldt n=48 participants at risk Initial LdT and Initial Placebo on LdT treatment after switching combined
Ear and labyrinth disorders Ear pain	0.00% 0/43 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 112 weeks. Adverse events occurring in patients in the Initial Placebo group were assigned to either Placebo or Telbivudine (LdT) treatment based on their onset date: * Placebo: AEs with onset before the first date of LdT treatment after switching; for patients who did not switch to LdT, all AEs were assigned to Placebo * LdT: AEs with onset date on or after the first date of LdT treatment after switching.	10.0% 1/10 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 112 weeks. Adverse events occurring in patients in the Initial Placebo group were assigned to either Placebo or Telbivudine (LdT) treatment based on their onset date: * Placebo: AEs with onset before the first date of LdT treatment after switching; for patients who did not switch to LdT, all AEs were assigned to Placebo * LdT: AEs with onset date on or after the first date of LdT treatment after switching.	0.00% 0/5 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 112 weeks. Adverse events occurring in patients in the Initial Placebo group were assigned to either Placebo or Telbivudine (LdT) treatment based on their onset date: * Placebo: AEs with onset before the first date of LdT treatment after switching; for patients who did not switch to LdT, all AEs were assigned to Placebo * LdT: AEs with onset date on or after the first date of LdT treatment after switching.	0.00% 0/48 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 112 weeks. Adverse events occurring in patients in the Initial Placebo group were assigned to either Placebo or Telbivudine (LdT) treatment based on their onset date: * Placebo: AEs with onset before the first date of LdT treatment after switching; for patients who did not switch to LdT, all AEs were assigned to Placebo * LdT: AEs with onset date on or after the first date of LdT treatment after switching.
Eye disorders Conjunctival hyperaemia	2.3% 1/43 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 112 weeks. Adverse events occurring in patients in the Initial Placebo group were assigned to either Placebo or Telbivudine (LdT) treatment based on their onset date: * Placebo: AEs with onset before the first date of LdT treatment after switching; for patients who did not switch to LdT, all AEs were assigned to Placebo * LdT: AEs with onset date on or after the first date of LdT treatment after switching.	0.00% 0/10 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 112 weeks. Adverse events occurring in patients in the Initial Placebo group were assigned to either Placebo or Telbivudine (LdT) treatment based on their onset date: * Placebo: AEs with onset before the first date of LdT treatment after switching; for patients who did not switch to LdT, all AEs were assigned to Placebo * LdT: AEs with onset date on or after the first date of LdT treatment after switching.	0.00% 0/5 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 112 weeks. Adverse events occurring in patients in the Initial Placebo group were assigned to either Placebo or Telbivudine (LdT) treatment based on their onset date: * Placebo: AEs with onset before the first date of LdT treatment after switching; for patients who did not switch to LdT, all AEs were assigned to Placebo * LdT: AEs with onset date on or after the first date of LdT treatment after switching.	2.1% 1/48 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 112 weeks. Adverse events occurring in patients in the Initial Placebo group were assigned to either Placebo or Telbivudine (LdT) treatment based on their onset date: * Placebo: AEs with onset before the first date of LdT treatment after switching; for patients who did not switch to LdT, all AEs were assigned to Placebo * LdT: AEs with onset date on or after the first date of LdT treatment after switching.
Gastrointestinal disorders Abdominal pain	2.3% 1/43 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 112 weeks. Adverse events occurring in patients in the Initial Placebo group were assigned to either Placebo or Telbivudine (LdT) treatment based on their onset date: * Placebo: AEs with onset before the first date of LdT treatment after switching; for patients who did not switch to LdT, all AEs were assigned to Placebo * LdT: AEs with onset date on or after the first date of LdT treatment after switching.	0.00% 0/10 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 112 weeks. Adverse events occurring in patients in the Initial Placebo group were assigned to either Placebo or Telbivudine (LdT) treatment based on their onset date: * Placebo: AEs with onset before the first date of LdT treatment after switching; for patients who did not switch to LdT, all AEs were assigned to Placebo * LdT: AEs with onset date on or after the first date of LdT treatment after switching.	0.00% 0/5 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 112 weeks. Adverse events occurring in patients in the Initial Placebo group were assigned to either Placebo or Telbivudine (LdT) treatment based on their onset date: * Placebo: AEs with onset before the first date of LdT treatment after switching; for patients who did not switch to LdT, all AEs were assigned to Placebo * LdT: AEs with onset date on or after the first date of LdT treatment after switching.	2.1% 1/48 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 112 weeks. Adverse events occurring in patients in the Initial Placebo group were assigned to either Placebo or Telbivudine (LdT) treatment based on their onset date: * Placebo: AEs with onset before the first date of LdT treatment after switching; for patients who did not switch to LdT, all AEs were assigned to Placebo * LdT: AEs with onset date on or after the first date of LdT treatment after switching.
Gastrointestinal disorders Abdominal pain upper	11.6% 5/43 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 112 weeks. Adverse events occurring in patients in the Initial Placebo group were assigned to either Placebo or Telbivudine (LdT) treatment based on their onset date: * Placebo: AEs with onset before the first date of LdT treatment after switching; for patients who did not switch to LdT, all AEs were assigned to Placebo * LdT: AEs with onset date on or after the first date of LdT treatment after switching.	0.00% 0/10 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 112 weeks. Adverse events occurring in patients in the Initial Placebo group were assigned to either Placebo or Telbivudine (LdT) treatment based on their onset date: * Placebo: AEs with onset before the first date of LdT treatment after switching; for patients who did not switch to LdT, all AEs were assigned to Placebo * LdT: AEs with onset date on or after the first date of LdT treatment after switching.	0.00% 0/5 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 112 weeks. Adverse events occurring in patients in the Initial Placebo group were assigned to either Placebo or Telbivudine (LdT) treatment based on their onset date: * Placebo: AEs with onset before the first date of LdT treatment after switching; for patients who did not switch to LdT, all AEs were assigned to Placebo * LdT: AEs with onset date on or after the first date of LdT treatment after switching.	10.4% 5/48 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 112 weeks. Adverse events occurring in patients in the Initial Placebo group were assigned to either Placebo or Telbivudine (LdT) treatment based on their onset date: * Placebo: AEs with onset before the first date of LdT treatment after switching; for patients who did not switch to LdT, all AEs were assigned to Placebo * LdT: AEs with onset date on or after the first date of LdT treatment after switching.
Gastrointestinal disorders Diarrhoea	4.7% 2/43 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 112 weeks. Adverse events occurring in patients in the Initial Placebo group were assigned to either Placebo or Telbivudine (LdT) treatment based on their onset date: * Placebo: AEs with onset before the first date of LdT treatment after switching; for patients who did not switch to LdT, all AEs were assigned to Placebo * LdT: AEs with onset date on or after the first date of LdT treatment after switching.	0.00% 0/10 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 112 weeks. Adverse events occurring in patients in the Initial Placebo group were assigned to either Placebo or Telbivudine (LdT) treatment based on their onset date: * Placebo: AEs with onset before the first date of LdT treatment after switching; for patients who did not switch to LdT, all AEs were assigned to Placebo * LdT: AEs with onset date on or after the first date of LdT treatment after switching.	0.00% 0/5 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 112 weeks. Adverse events occurring in patients in the Initial Placebo group were assigned to either Placebo or Telbivudine (LdT) treatment based on their onset date: * Placebo: AEs with onset before the first date of LdT treatment after switching; for patients who did not switch to LdT, all AEs were assigned to Placebo * LdT: AEs with onset date on or after the first date of LdT treatment after switching.	4.2% 2/48 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 112 weeks. Adverse events occurring in patients in the Initial Placebo group were assigned to either Placebo or Telbivudine (LdT) treatment based on their onset date: * Placebo: AEs with onset before the first date of LdT treatment after switching; for patients who did not switch to LdT, all AEs were assigned to Placebo * LdT: AEs with onset date on or after the first date of LdT treatment after switching.
Gastrointestinal disorders Nausea	0.00% 0/43 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 112 weeks. Adverse events occurring in patients in the Initial Placebo group were assigned to either Placebo or Telbivudine (LdT) treatment based on their onset date: * Placebo: AEs with onset before the first date of LdT treatment after switching; for patients who did not switch to LdT, all AEs were assigned to Placebo * LdT: AEs with onset date on or after the first date of LdT treatment after switching.	10.0% 1/10 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 112 weeks. Adverse events occurring in patients in the Initial Placebo group were assigned to either Placebo or Telbivudine (LdT) treatment based on their onset date: * Placebo: AEs with onset before the first date of LdT treatment after switching; for patients who did not switch to LdT, all AEs were assigned to Placebo * LdT: AEs with onset date on or after the first date of LdT treatment after switching.	0.00% 0/5 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 112 weeks. Adverse events occurring in patients in the Initial Placebo group were assigned to either Placebo or Telbivudine (LdT) treatment based on their onset date: * Placebo: AEs with onset before the first date of LdT treatment after switching; for patients who did not switch to LdT, all AEs were assigned to Placebo * LdT: AEs with onset date on or after the first date of LdT treatment after switching.	0.00% 0/48 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 112 weeks. Adverse events occurring in patients in the Initial Placebo group were assigned to either Placebo or Telbivudine (LdT) treatment based on their onset date: * Placebo: AEs with onset before the first date of LdT treatment after switching; for patients who did not switch to LdT, all AEs were assigned to Placebo * LdT: AEs with onset date on or after the first date of LdT treatment after switching.
Gastrointestinal disorders Vomiting	2.3% 1/43 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 112 weeks. Adverse events occurring in patients in the Initial Placebo group were assigned to either Placebo or Telbivudine (LdT) treatment based on their onset date: * Placebo: AEs with onset before the first date of LdT treatment after switching; for patients who did not switch to LdT, all AEs were assigned to Placebo * LdT: AEs with onset date on or after the first date of LdT treatment after switching.	0.00% 0/10 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 112 weeks. Adverse events occurring in patients in the Initial Placebo group were assigned to either Placebo or Telbivudine (LdT) treatment based on their onset date: * Placebo: AEs with onset before the first date of LdT treatment after switching; for patients who did not switch to LdT, all AEs were assigned to Placebo * LdT: AEs with onset date on or after the first date of LdT treatment after switching.	0.00% 0/5 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 112 weeks. Adverse events occurring in patients in the Initial Placebo group were assigned to either Placebo or Telbivudine (LdT) treatment based on their onset date: * Placebo: AEs with onset before the first date of LdT treatment after switching; for patients who did not switch to LdT, all AEs were assigned to Placebo * LdT: AEs with onset date on or after the first date of LdT treatment after switching.	2.1% 1/48 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 112 weeks. Adverse events occurring in patients in the Initial Placebo group were assigned to either Placebo or Telbivudine (LdT) treatment based on their onset date: * Placebo: AEs with onset before the first date of LdT treatment after switching; for patients who did not switch to LdT, all AEs were assigned to Placebo * LdT: AEs with onset date on or after the first date of LdT treatment after switching.
Infections and infestations Exanthema subitum	2.3% 1/43 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 112 weeks. Adverse events occurring in patients in the Initial Placebo group were assigned to either Placebo or Telbivudine (LdT) treatment based on their onset date: * Placebo: AEs with onset before the first date of LdT treatment after switching; for patients who did not switch to LdT, all AEs were assigned to Placebo * LdT: AEs with onset date on or after the first date of LdT treatment after switching.	0.00% 0/10 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 112 weeks. Adverse events occurring in patients in the Initial Placebo group were assigned to either Placebo or Telbivudine (LdT) treatment based on their onset date: * Placebo: AEs with onset before the first date of LdT treatment after switching; for patients who did not switch to LdT, all AEs were assigned to Placebo * LdT: AEs with onset date on or after the first date of LdT treatment after switching.	0.00% 0/5 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 112 weeks. Adverse events occurring in patients in the Initial Placebo group were assigned to either Placebo or Telbivudine (LdT) treatment based on their onset date: * Placebo: AEs with onset before the first date of LdT treatment after switching; for patients who did not switch to LdT, all AEs were assigned to Placebo * LdT: AEs with onset date on or after the first date of LdT treatment after switching.	2.1% 1/48 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 112 weeks. Adverse events occurring in patients in the Initial Placebo group were assigned to either Placebo or Telbivudine (LdT) treatment based on their onset date: * Placebo: AEs with onset before the first date of LdT treatment after switching; for patients who did not switch to LdT, all AEs were assigned to Placebo * LdT: AEs with onset date on or after the first date of LdT treatment after switching.
Infections and infestations Gastroenteritis	4.7% 2/43 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 112 weeks. Adverse events occurring in patients in the Initial Placebo group were assigned to either Placebo or Telbivudine (LdT) treatment based on their onset date: * Placebo: AEs with onset before the first date of LdT treatment after switching; for patients who did not switch to LdT, all AEs were assigned to Placebo * LdT: AEs with onset date on or after the first date of LdT treatment after switching.	0.00% 0/10 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 112 weeks. Adverse events occurring in patients in the Initial Placebo group were assigned to either Placebo or Telbivudine (LdT) treatment based on their onset date: * Placebo: AEs with onset before the first date of LdT treatment after switching; for patients who did not switch to LdT, all AEs were assigned to Placebo * LdT: AEs with onset date on or after the first date of LdT treatment after switching.	0.00% 0/5 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 112 weeks. Adverse events occurring in patients in the Initial Placebo group were assigned to either Placebo or Telbivudine (LdT) treatment based on their onset date: * Placebo: AEs with onset before the first date of LdT treatment after switching; for patients who did not switch to LdT, all AEs were assigned to Placebo * LdT: AEs with onset date on or after the first date of LdT treatment after switching.	4.2% 2/48 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 112 weeks. Adverse events occurring in patients in the Initial Placebo group were assigned to either Placebo or Telbivudine (LdT) treatment based on their onset date: * Placebo: AEs with onset before the first date of LdT treatment after switching; for patients who did not switch to LdT, all AEs were assigned to Placebo * LdT: AEs with onset date on or after the first date of LdT treatment after switching.
Infections and infestations Laryngitis	2.3% 1/43 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 112 weeks. Adverse events occurring in patients in the Initial Placebo group were assigned to either Placebo or Telbivudine (LdT) treatment based on their onset date: * Placebo: AEs with onset before the first date of LdT treatment after switching; for patients who did not switch to LdT, all AEs were assigned to Placebo * LdT: AEs with onset date on or after the first date of LdT treatment after switching.	0.00% 0/10 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 112 weeks. Adverse events occurring in patients in the Initial Placebo group were assigned to either Placebo or Telbivudine (LdT) treatment based on their onset date: * Placebo: AEs with onset before the first date of LdT treatment after switching; for patients who did not switch to LdT, all AEs were assigned to Placebo * LdT: AEs with onset date on or after the first date of LdT treatment after switching.	0.00% 0/5 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 112 weeks. Adverse events occurring in patients in the Initial Placebo group were assigned to either Placebo or Telbivudine (LdT) treatment based on their onset date: * Placebo: AEs with onset before the first date of LdT treatment after switching; for patients who did not switch to LdT, all AEs were assigned to Placebo * LdT: AEs with onset date on or after the first date of LdT treatment after switching.	2.1% 1/48 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 112 weeks. Adverse events occurring in patients in the Initial Placebo group were assigned to either Placebo or Telbivudine (LdT) treatment based on their onset date: * Placebo: AEs with onset before the first date of LdT treatment after switching; for patients who did not switch to LdT, all AEs were assigned to Placebo * LdT: AEs with onset date on or after the first date of LdT treatment after switching.
Infections and infestations Nasopharyngitis	0.00% 0/43 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 112 weeks. Adverse events occurring in patients in the Initial Placebo group were assigned to either Placebo or Telbivudine (LdT) treatment based on their onset date: * Placebo: AEs with onset before the first date of LdT treatment after switching; for patients who did not switch to LdT, all AEs were assigned to Placebo * LdT: AEs with onset date on or after the first date of LdT treatment after switching.	0.00% 0/10 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 112 weeks. Adverse events occurring in patients in the Initial Placebo group were assigned to either Placebo or Telbivudine (LdT) treatment based on their onset date: * Placebo: AEs with onset before the first date of LdT treatment after switching; for patients who did not switch to LdT, all AEs were assigned to Placebo * LdT: AEs with onset date on or after the first date of LdT treatment after switching.	20.0% 1/5 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 112 weeks. Adverse events occurring in patients in the Initial Placebo group were assigned to either Placebo or Telbivudine (LdT) treatment based on their onset date: * Placebo: AEs with onset before the first date of LdT treatment after switching; for patients who did not switch to LdT, all AEs were assigned to Placebo * LdT: AEs with onset date on or after the first date of LdT treatment after switching.	2.1% 1/48 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 112 weeks. Adverse events occurring in patients in the Initial Placebo group were assigned to either Placebo or Telbivudine (LdT) treatment based on their onset date: * Placebo: AEs with onset before the first date of LdT treatment after switching; for patients who did not switch to LdT, all AEs were assigned to Placebo * LdT: AEs with onset date on or after the first date of LdT treatment after switching.
Infections and infestations Otitis media	2.3% 1/43 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 112 weeks. Adverse events occurring in patients in the Initial Placebo group were assigned to either Placebo or Telbivudine (LdT) treatment based on their onset date: * Placebo: AEs with onset before the first date of LdT treatment after switching; for patients who did not switch to LdT, all AEs were assigned to Placebo * LdT: AEs with onset date on or after the first date of LdT treatment after switching.	0.00% 0/10 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 112 weeks. Adverse events occurring in patients in the Initial Placebo group were assigned to either Placebo or Telbivudine (LdT) treatment based on their onset date: * Placebo: AEs with onset before the first date of LdT treatment after switching; for patients who did not switch to LdT, all AEs were assigned to Placebo * LdT: AEs with onset date on or after the first date of LdT treatment after switching.	0.00% 0/5 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 112 weeks. Adverse events occurring in patients in the Initial Placebo group were assigned to either Placebo or Telbivudine (LdT) treatment based on their onset date: * Placebo: AEs with onset before the first date of LdT treatment after switching; for patients who did not switch to LdT, all AEs were assigned to Placebo * LdT: AEs with onset date on or after the first date of LdT treatment after switching.	2.1% 1/48 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 112 weeks. Adverse events occurring in patients in the Initial Placebo group were assigned to either Placebo or Telbivudine (LdT) treatment based on their onset date: * Placebo: AEs with onset before the first date of LdT treatment after switching; for patients who did not switch to LdT, all AEs were assigned to Placebo * LdT: AEs with onset date on or after the first date of LdT treatment after switching.
Infections and infestations Pharyngitis	2.3% 1/43 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 112 weeks. Adverse events occurring in patients in the Initial Placebo group were assigned to either Placebo or Telbivudine (LdT) treatment based on their onset date: * Placebo: AEs with onset before the first date of LdT treatment after switching; for patients who did not switch to LdT, all AEs were assigned to Placebo * LdT: AEs with onset date on or after the first date of LdT treatment after switching.	0.00% 0/10 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 112 weeks. Adverse events occurring in patients in the Initial Placebo group were assigned to either Placebo or Telbivudine (LdT) treatment based on their onset date: * Placebo: AEs with onset before the first date of LdT treatment after switching; for patients who did not switch to LdT, all AEs were assigned to Placebo * LdT: AEs with onset date on or after the first date of LdT treatment after switching.	0.00% 0/5 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 112 weeks. Adverse events occurring in patients in the Initial Placebo group were assigned to either Placebo or Telbivudine (LdT) treatment based on their onset date: * Placebo: AEs with onset before the first date of LdT treatment after switching; for patients who did not switch to LdT, all AEs were assigned to Placebo * LdT: AEs with onset date on or after the first date of LdT treatment after switching.	2.1% 1/48 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 112 weeks. Adverse events occurring in patients in the Initial Placebo group were assigned to either Placebo or Telbivudine (LdT) treatment based on their onset date: * Placebo: AEs with onset before the first date of LdT treatment after switching; for patients who did not switch to LdT, all AEs were assigned to Placebo * LdT: AEs with onset date on or after the first date of LdT treatment after switching.
Infections and infestations Tonsillitis	2.3% 1/43 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 112 weeks. Adverse events occurring in patients in the Initial Placebo group were assigned to either Placebo or Telbivudine (LdT) treatment based on their onset date: * Placebo: AEs with onset before the first date of LdT treatment after switching; for patients who did not switch to LdT, all AEs were assigned to Placebo * LdT: AEs with onset date on or after the first date of LdT treatment after switching.	10.0% 1/10 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 112 weeks. Adverse events occurring in patients in the Initial Placebo group were assigned to either Placebo or Telbivudine (LdT) treatment based on their onset date: * Placebo: AEs with onset before the first date of LdT treatment after switching; for patients who did not switch to LdT, all AEs were assigned to Placebo * LdT: AEs with onset date on or after the first date of LdT treatment after switching.	0.00% 0/5 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 112 weeks. Adverse events occurring in patients in the Initial Placebo group were assigned to either Placebo or Telbivudine (LdT) treatment based on their onset date: * Placebo: AEs with onset before the first date of LdT treatment after switching; for patients who did not switch to LdT, all AEs were assigned to Placebo * LdT: AEs with onset date on or after the first date of LdT treatment after switching.	2.1% 1/48 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 112 weeks. Adverse events occurring in patients in the Initial Placebo group were assigned to either Placebo or Telbivudine (LdT) treatment based on their onset date: * Placebo: AEs with onset before the first date of LdT treatment after switching; for patients who did not switch to LdT, all AEs were assigned to Placebo * LdT: AEs with onset date on or after the first date of LdT treatment after switching.
Infections and infestations Upper respiratory tract infection	2.3% 1/43 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 112 weeks. Adverse events occurring in patients in the Initial Placebo group were assigned to either Placebo or Telbivudine (LdT) treatment based on their onset date: * Placebo: AEs with onset before the first date of LdT treatment after switching; for patients who did not switch to LdT, all AEs were assigned to Placebo * LdT: AEs with onset date on or after the first date of LdT treatment after switching.	10.0% 1/10 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 112 weeks. Adverse events occurring in patients in the Initial Placebo group were assigned to either Placebo or Telbivudine (LdT) treatment based on their onset date: * Placebo: AEs with onset before the first date of LdT treatment after switching; for patients who did not switch to LdT, all AEs were assigned to Placebo * LdT: AEs with onset date on or after the first date of LdT treatment after switching.	0.00% 0/5 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 112 weeks. Adverse events occurring in patients in the Initial Placebo group were assigned to either Placebo or Telbivudine (LdT) treatment based on their onset date: * Placebo: AEs with onset before the first date of LdT treatment after switching; for patients who did not switch to LdT, all AEs were assigned to Placebo * LdT: AEs with onset date on or after the first date of LdT treatment after switching.	2.1% 1/48 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 112 weeks. Adverse events occurring in patients in the Initial Placebo group were assigned to either Placebo or Telbivudine (LdT) treatment based on their onset date: * Placebo: AEs with onset before the first date of LdT treatment after switching; for patients who did not switch to LdT, all AEs were assigned to Placebo * LdT: AEs with onset date on or after the first date of LdT treatment after switching.
Infections and infestations Varicella	2.3% 1/43 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 112 weeks. Adverse events occurring in patients in the Initial Placebo group were assigned to either Placebo or Telbivudine (LdT) treatment based on their onset date: * Placebo: AEs with onset before the first date of LdT treatment after switching; for patients who did not switch to LdT, all AEs were assigned to Placebo * LdT: AEs with onset date on or after the first date of LdT treatment after switching.	0.00% 0/10 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 112 weeks. Adverse events occurring in patients in the Initial Placebo group were assigned to either Placebo or Telbivudine (LdT) treatment based on their onset date: * Placebo: AEs with onset before the first date of LdT treatment after switching; for patients who did not switch to LdT, all AEs were assigned to Placebo * LdT: AEs with onset date on or after the first date of LdT treatment after switching.	0.00% 0/5 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 112 weeks. Adverse events occurring in patients in the Initial Placebo group were assigned to either Placebo or Telbivudine (LdT) treatment based on their onset date: * Placebo: AEs with onset before the first date of LdT treatment after switching; for patients who did not switch to LdT, all AEs were assigned to Placebo * LdT: AEs with onset date on or after the first date of LdT treatment after switching.	2.1% 1/48 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 112 weeks. Adverse events occurring in patients in the Initial Placebo group were assigned to either Placebo or Telbivudine (LdT) treatment based on their onset date: * Placebo: AEs with onset before the first date of LdT treatment after switching; for patients who did not switch to LdT, all AEs were assigned to Placebo * LdT: AEs with onset date on or after the first date of LdT treatment after switching.
Infections and infestations Viral infection	2.3% 1/43 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 112 weeks. Adverse events occurring in patients in the Initial Placebo group were assigned to either Placebo or Telbivudine (LdT) treatment based on their onset date: * Placebo: AEs with onset before the first date of LdT treatment after switching; for patients who did not switch to LdT, all AEs were assigned to Placebo * LdT: AEs with onset date on or after the first date of LdT treatment after switching.	0.00% 0/10 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 112 weeks. Adverse events occurring in patients in the Initial Placebo group were assigned to either Placebo or Telbivudine (LdT) treatment based on their onset date: * Placebo: AEs with onset before the first date of LdT treatment after switching; for patients who did not switch to LdT, all AEs were assigned to Placebo * LdT: AEs with onset date on or after the first date of LdT treatment after switching.	0.00% 0/5 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 112 weeks. Adverse events occurring in patients in the Initial Placebo group were assigned to either Placebo or Telbivudine (LdT) treatment based on their onset date: * Placebo: AEs with onset before the first date of LdT treatment after switching; for patients who did not switch to LdT, all AEs were assigned to Placebo * LdT: AEs with onset date on or after the first date of LdT treatment after switching.	2.1% 1/48 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 112 weeks. Adverse events occurring in patients in the Initial Placebo group were assigned to either Placebo or Telbivudine (LdT) treatment based on their onset date: * Placebo: AEs with onset before the first date of LdT treatment after switching; for patients who did not switch to LdT, all AEs were assigned to Placebo * LdT: AEs with onset date on or after the first date of LdT treatment after switching.
Infections and infestations Viral upper respiratory tract infection	7.0% 3/43 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 112 weeks. Adverse events occurring in patients in the Initial Placebo group were assigned to either Placebo or Telbivudine (LdT) treatment based on their onset date: * Placebo: AEs with onset before the first date of LdT treatment after switching; for patients who did not switch to LdT, all AEs were assigned to Placebo * LdT: AEs with onset date on or after the first date of LdT treatment after switching.	0.00% 0/10 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 112 weeks. Adverse events occurring in patients in the Initial Placebo group were assigned to either Placebo or Telbivudine (LdT) treatment based on their onset date: * Placebo: AEs with onset before the first date of LdT treatment after switching; for patients who did not switch to LdT, all AEs were assigned to Placebo * LdT: AEs with onset date on or after the first date of LdT treatment after switching.	0.00% 0/5 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 112 weeks. Adverse events occurring in patients in the Initial Placebo group were assigned to either Placebo or Telbivudine (LdT) treatment based on their onset date: * Placebo: AEs with onset before the first date of LdT treatment after switching; for patients who did not switch to LdT, all AEs were assigned to Placebo * LdT: AEs with onset date on or after the first date of LdT treatment after switching.	6.2% 3/48 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 112 weeks. Adverse events occurring in patients in the Initial Placebo group were assigned to either Placebo or Telbivudine (LdT) treatment based on their onset date: * Placebo: AEs with onset before the first date of LdT treatment after switching; for patients who did not switch to LdT, all AEs were assigned to Placebo * LdT: AEs with onset date on or after the first date of LdT treatment after switching.
Investigations Blood creatine phosphokinase increased	4.7% 2/43 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 112 weeks. Adverse events occurring in patients in the Initial Placebo group were assigned to either Placebo or Telbivudine (LdT) treatment based on their onset date: * Placebo: AEs with onset before the first date of LdT treatment after switching; for patients who did not switch to LdT, all AEs were assigned to Placebo * LdT: AEs with onset date on or after the first date of LdT treatment after switching.	0.00% 0/10 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 112 weeks. Adverse events occurring in patients in the Initial Placebo group were assigned to either Placebo or Telbivudine (LdT) treatment based on their onset date: * Placebo: AEs with onset before the first date of LdT treatment after switching; for patients who did not switch to LdT, all AEs were assigned to Placebo * LdT: AEs with onset date on or after the first date of LdT treatment after switching.	0.00% 0/5 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 112 weeks. Adverse events occurring in patients in the Initial Placebo group were assigned to either Placebo or Telbivudine (LdT) treatment based on their onset date: * Placebo: AEs with onset before the first date of LdT treatment after switching; for patients who did not switch to LdT, all AEs were assigned to Placebo * LdT: AEs with onset date on or after the first date of LdT treatment after switching.	4.2% 2/48 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 112 weeks. Adverse events occurring in patients in the Initial Placebo group were assigned to either Placebo or Telbivudine (LdT) treatment based on their onset date: * Placebo: AEs with onset before the first date of LdT treatment after switching; for patients who did not switch to LdT, all AEs were assigned to Placebo * LdT: AEs with onset date on or after the first date of LdT treatment after switching.
Musculoskeletal and connective tissue disorders Myalgia	2.3% 1/43 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 112 weeks. Adverse events occurring in patients in the Initial Placebo group were assigned to either Placebo or Telbivudine (LdT) treatment based on their onset date: * Placebo: AEs with onset before the first date of LdT treatment after switching; for patients who did not switch to LdT, all AEs were assigned to Placebo * LdT: AEs with onset date on or after the first date of LdT treatment after switching.	0.00% 0/10 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 112 weeks. Adverse events occurring in patients in the Initial Placebo group were assigned to either Placebo or Telbivudine (LdT) treatment based on their onset date: * Placebo: AEs with onset before the first date of LdT treatment after switching; for patients who did not switch to LdT, all AEs were assigned to Placebo * LdT: AEs with onset date on or after the first date of LdT treatment after switching.	0.00% 0/5 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 112 weeks. Adverse events occurring in patients in the Initial Placebo group were assigned to either Placebo or Telbivudine (LdT) treatment based on their onset date: * Placebo: AEs with onset before the first date of LdT treatment after switching; for patients who did not switch to LdT, all AEs were assigned to Placebo * LdT: AEs with onset date on or after the first date of LdT treatment after switching.	2.1% 1/48 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 112 weeks. Adverse events occurring in patients in the Initial Placebo group were assigned to either Placebo or Telbivudine (LdT) treatment based on their onset date: * Placebo: AEs with onset before the first date of LdT treatment after switching; for patients who did not switch to LdT, all AEs were assigned to Placebo * LdT: AEs with onset date on or after the first date of LdT treatment after switching.
Nervous system disorders Dizziness	2.3% 1/43 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 112 weeks. Adverse events occurring in patients in the Initial Placebo group were assigned to either Placebo or Telbivudine (LdT) treatment based on their onset date: * Placebo: AEs with onset before the first date of LdT treatment after switching; for patients who did not switch to LdT, all AEs were assigned to Placebo * LdT: AEs with onset date on or after the first date of LdT treatment after switching.	0.00% 0/10 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 112 weeks. Adverse events occurring in patients in the Initial Placebo group were assigned to either Placebo or Telbivudine (LdT) treatment based on their onset date: * Placebo: AEs with onset before the first date of LdT treatment after switching; for patients who did not switch to LdT, all AEs were assigned to Placebo * LdT: AEs with onset date on or after the first date of LdT treatment after switching.	0.00% 0/5 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 112 weeks. Adverse events occurring in patients in the Initial Placebo group were assigned to either Placebo or Telbivudine (LdT) treatment based on their onset date: * Placebo: AEs with onset before the first date of LdT treatment after switching; for patients who did not switch to LdT, all AEs were assigned to Placebo * LdT: AEs with onset date on or after the first date of LdT treatment after switching.	2.1% 1/48 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 112 weeks. Adverse events occurring in patients in the Initial Placebo group were assigned to either Placebo or Telbivudine (LdT) treatment based on their onset date: * Placebo: AEs with onset before the first date of LdT treatment after switching; for patients who did not switch to LdT, all AEs were assigned to Placebo * LdT: AEs with onset date on or after the first date of LdT treatment after switching.
Nervous system disorders Headache	14.0% 6/43 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 112 weeks. Adverse events occurring in patients in the Initial Placebo group were assigned to either Placebo or Telbivudine (LdT) treatment based on their onset date: * Placebo: AEs with onset before the first date of LdT treatment after switching; for patients who did not switch to LdT, all AEs were assigned to Placebo * LdT: AEs with onset date on or after the first date of LdT treatment after switching.	10.0% 1/10 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 112 weeks. Adverse events occurring in patients in the Initial Placebo group were assigned to either Placebo or Telbivudine (LdT) treatment based on their onset date: * Placebo: AEs with onset before the first date of LdT treatment after switching; for patients who did not switch to LdT, all AEs were assigned to Placebo * LdT: AEs with onset date on or after the first date of LdT treatment after switching.	0.00% 0/5 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 112 weeks. Adverse events occurring in patients in the Initial Placebo group were assigned to either Placebo or Telbivudine (LdT) treatment based on their onset date: * Placebo: AEs with onset before the first date of LdT treatment after switching; for patients who did not switch to LdT, all AEs were assigned to Placebo * LdT: AEs with onset date on or after the first date of LdT treatment after switching.	12.5% 6/48 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 112 weeks. Adverse events occurring in patients in the Initial Placebo group were assigned to either Placebo or Telbivudine (LdT) treatment based on their onset date: * Placebo: AEs with onset before the first date of LdT treatment after switching; for patients who did not switch to LdT, all AEs were assigned to Placebo * LdT: AEs with onset date on or after the first date of LdT treatment after switching.
Respiratory, thoracic and mediastinal disorders Cough	2.3% 1/43 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 112 weeks. Adverse events occurring in patients in the Initial Placebo group were assigned to either Placebo or Telbivudine (LdT) treatment based on their onset date: * Placebo: AEs with onset before the first date of LdT treatment after switching; for patients who did not switch to LdT, all AEs were assigned to Placebo * LdT: AEs with onset date on or after the first date of LdT treatment after switching.	0.00% 0/10 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 112 weeks. Adverse events occurring in patients in the Initial Placebo group were assigned to either Placebo or Telbivudine (LdT) treatment based on their onset date: * Placebo: AEs with onset before the first date of LdT treatment after switching; for patients who did not switch to LdT, all AEs were assigned to Placebo * LdT: AEs with onset date on or after the first date of LdT treatment after switching.	0.00% 0/5 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 112 weeks. Adverse events occurring in patients in the Initial Placebo group were assigned to either Placebo or Telbivudine (LdT) treatment based on their onset date: * Placebo: AEs with onset before the first date of LdT treatment after switching; for patients who did not switch to LdT, all AEs were assigned to Placebo * LdT: AEs with onset date on or after the first date of LdT treatment after switching.	2.1% 1/48 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 112 weeks. Adverse events occurring in patients in the Initial Placebo group were assigned to either Placebo or Telbivudine (LdT) treatment based on their onset date: * Placebo: AEs with onset before the first date of LdT treatment after switching; for patients who did not switch to LdT, all AEs were assigned to Placebo * LdT: AEs with onset date on or after the first date of LdT treatment after switching.
Respiratory, thoracic and mediastinal disorders Epistaxis	4.7% 2/43 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 112 weeks. Adverse events occurring in patients in the Initial Placebo group were assigned to either Placebo or Telbivudine (LdT) treatment based on their onset date: * Placebo: AEs with onset before the first date of LdT treatment after switching; for patients who did not switch to LdT, all AEs were assigned to Placebo * LdT: AEs with onset date on or after the first date of LdT treatment after switching.	0.00% 0/10 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 112 weeks. Adverse events occurring in patients in the Initial Placebo group were assigned to either Placebo or Telbivudine (LdT) treatment based on their onset date: * Placebo: AEs with onset before the first date of LdT treatment after switching; for patients who did not switch to LdT, all AEs were assigned to Placebo * LdT: AEs with onset date on or after the first date of LdT treatment after switching.	0.00% 0/5 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 112 weeks. Adverse events occurring in patients in the Initial Placebo group were assigned to either Placebo or Telbivudine (LdT) treatment based on their onset date: * Placebo: AEs with onset before the first date of LdT treatment after switching; for patients who did not switch to LdT, all AEs were assigned to Placebo * LdT: AEs with onset date on or after the first date of LdT treatment after switching.	4.2% 2/48 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 112 weeks. Adverse events occurring in patients in the Initial Placebo group were assigned to either Placebo or Telbivudine (LdT) treatment based on their onset date: * Placebo: AEs with onset before the first date of LdT treatment after switching; for patients who did not switch to LdT, all AEs were assigned to Placebo * LdT: AEs with onset date on or after the first date of LdT treatment after switching.
Surgical and medical procedures Antibiotic prophylaxis	0.00% 0/43 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 112 weeks. Adverse events occurring in patients in the Initial Placebo group were assigned to either Placebo or Telbivudine (LdT) treatment based on their onset date: * Placebo: AEs with onset before the first date of LdT treatment after switching; for patients who did not switch to LdT, all AEs were assigned to Placebo * LdT: AEs with onset date on or after the first date of LdT treatment after switching.	10.0% 1/10 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 112 weeks. Adverse events occurring in patients in the Initial Placebo group were assigned to either Placebo or Telbivudine (LdT) treatment based on their onset date: * Placebo: AEs with onset before the first date of LdT treatment after switching; for patients who did not switch to LdT, all AEs were assigned to Placebo * LdT: AEs with onset date on or after the first date of LdT treatment after switching.	0.00% 0/5 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 112 weeks. Adverse events occurring in patients in the Initial Placebo group were assigned to either Placebo or Telbivudine (LdT) treatment based on their onset date: * Placebo: AEs with onset before the first date of LdT treatment after switching; for patients who did not switch to LdT, all AEs were assigned to Placebo * LdT: AEs with onset date on or after the first date of LdT treatment after switching.	0.00% 0/48 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 112 weeks. Adverse events occurring in patients in the Initial Placebo group were assigned to either Placebo or Telbivudine (LdT) treatment based on their onset date: * Placebo: AEs with onset before the first date of LdT treatment after switching; for patients who did not switch to LdT, all AEs were assigned to Placebo * LdT: AEs with onset date on or after the first date of LdT treatment after switching.

Additional Information

Study Director

Novartis Pharmaceuticals

Phone: 862-778-8300

Email: Novartis.email@novartis.com

Results disclosure agreements

• Principal investigator is a sponsor employee 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 (ie, data from all sites) in the clinical trial.
• Publication restrictions are in place

Restriction type: OTHER