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TerminatedNCT02058108Updated Sep 10, 2019Results posted

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

A Phase 3 interventional study of Telbivudine and Placebo in Chronic Hepatitis B, sponsored by Novartis Pharmaceuticals. Terminated at 29 sites in 7 countries. Open to participants aged 2 Years to 17 Years. Per ClinicalTrials.gov, last updated 2019-09-10.

Sponsored by Novartis Pharmaceuticals · Phase 3, Interventional, and Treatment

Why this study was terminated
Study terminated on the recommendation of an independent Data Monitoring Committee (DMC) subsequent to an interim efficacy analysis for futility.\]
Phase
Phase 3
Study type
Interventional
Enrollment
53
Allocation
Randomized
Ages
2 Years to 17 Years
Sex
All
01

Study summary

The purpose of the study was to assess the efficacy and safety of telbivudine at a dose of 20 mg/kg up to a maximum of 600 mg q.d. in compensated pediatric HBeAg-positive and negative CHB patients aged 2 to \<18 years with the indication of antiviral CHB treatment. This study was part of the commitments of the pediatric development plan for telbivudine in Europe and US.

02

Conditions studied

  • Chronic Hepatitis B

Keywords

  • Chronic hepatitis B, pediatrics, antiviral treatment, telbivudine
03

In context

Hepatitis A

2,709 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.

This study's enrollment of 53 is below the median of 100 across 1,886 interventional studies indexed under Hepatitis A.

Browse Hepatitis A studies →

Lead sponsor

Novartis Pharmaceuticals is the lead sponsor of 2,673 studies on the registry; 228 are open to participants now.

Of its 576 completed or terminated interventional studies of FDA-regulated products, 431 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Key Inclusion Criteria:

  • Clinical history compatible with compensated chronic hepatitis B

  • Documented compensated chronic hepatitis B defined by the following:

    1. Positive serum HBsAg at screening and at least one other documentation of HBsAg positive at least 6 months prior to screening
    2. For HBeAg positive patients at screening, significant biologic and/or histologic signs of disease activity following EASL guidelines recommendations for CHB pediatric patients (serum HBV DNA level ≥ 5 log10 copies/mL (or 20 000 IU/mL) (COBAS Taqman®) at screening ; serum ALT ≥ 1.5×ULN and \< 10×ULN (pediatric ULN) for two times during the screening period or within 6 months prior to screening
    3. For HBeAg negative patients at screening, significant biologic and/or histologic signs of disease activity following EASL guidelines recommendations for CHB pediatric patients (serum HBV DNA level ≥ 4 log10 copies/mL (or 2 000 IU/mL) (COBAS Taqman®) at screening) ; serum ALT ≥ 1.0 ×ULN and \< 10×ULN (pediatric ULN) for two times during the screening period or within 12 months prior to screening)

Key Exclusion Criteria:

  • Patients with acute or chronic infection of HCV, HDV, HIV, or with acute infection of HAV, HEV, CMV, EBV, or HSV.
  • Patient has received treatment of interferon or any other immunomodulatory agents within the last 12 months prior to screening or any nucleoside or nucleotide drugs or other anti-CHB treatment (approved or investigational) at any time before screening
  • Patient has a medical condition that requires frequent use of systemic acyclovir or famciclovir, systemic corticosteroids, potentially hepatotoxic drugs or nephrotoxic drugs or chemotherapy
  • Patient has one or more additional known primary or secondary causes of liver disease, other than CHB; has a decompensated liver disease ; is a Liver transplant recipient or organ or bone marrow transplant recipient.
  • History of any other acute or chronic medical condition (that in the opinion of the investigator would make the patient unsuitable for inclusion into the study.
  • Patient has a history of myopathy, myositis, persistent muscle weakness or persistent high serum CK levels (≥7×ULN), any muscular disease
  • Patient receiving any drugs potentially associated with myopathy within 3 months prior to screening
  • Any other clinical significant disease, condition or abnormality, unrelated to their HBV infection at screening, as assessed by the investigator
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
53 participants (actual)

Study arms

  • Experimental
    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

    Drug: Telbivudine

  • Placebo comparator
    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

    Drug: Placebo

Interventions

  • DrugTelbivudine

    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

  • DrugPlacebo

    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

06

What researchers measure

Primary outcomes

  1. Number of Patients Achieving Serum HBV DNA Level of <300 Copies/mL (51 IU/mL) at Week 24

    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.

    Time frame: Week 24

Secondary outcomes

  1. Number of Patients Achieving HBV DNA< 300 Copies/mL (51 IU/mL) at Week 52 and Week 104

    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.

    Time frame: Week 52, Week 104

  2. Number of Patients Whose Baseline ALTs Were Abnormal and Subsequently Normalized at Week 24, 52 and 104

    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.

    Time frame: Week 24, Week 52, Week 104

  3. Number of Patients With HBeAg Loss, HBeAg Seroconversion at Week 24, 52 and 104

    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.

    Time frame: Week 24, Week 52, Week 104

  4. Number of Patients With HBsAg Loss, HBsAg Seroconversion at Week 24, 52 and 104

    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.

    Time frame: Week 24, Week 52, Week 104

  5. 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

    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.

    Time frame: Week 52, Week 104

  6. Number of Patients Achieving Cumulative Rate of Virological Breakthrough (VB) at Week 52 and 104

    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.

    Time frame: Week 52, Week 104

  7. 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

    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)

    Time frame: Week 24

  8. Number of Participants With On-Treatments Adverse Events, Serious Adverse Events, and Death

    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.

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

07

Results

Posted Sep 10, 2019
Limitations and caveats
Due to early termination of the study and limited number of enrolled patients on track to complete 52 weeks of participation (8 patients overall), no formal analysis of Weeks 52 and 104 long-term efficacy endpoints (only descriptive analysis).

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).

Participant flow — Overall Study
MilestoneTelbivudinePlacebo
Started4310
Switched to telbivudine after week 2405
Completed20
Not completed4110
Withdrew: Abnormal laboratory values01
Withdrew: Unsatisfactory therapeutic effect374
Withdrew: No longer requires study drug01
Withdrew: Withdrawal by subject10
Withdrew: Administrative problems33
Withdrew: Protocol violation01

Outcome measures

PrimaryNumber of Patients Achieving Serum HBV DNA Level of <300 Copies/mL (51 IU/mL) at Week 24

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.

Time frame:
Week 24
Reported as:
Count of participants · Participants
Number of Patients Achieving Serum HBV DNA Level of <300 Copies/mL (51 IU/mL) at Week 24
ParticipantsTelbivudinePlacebo
Number of Patients Achieving Serum HBV DNA Level of <300 Copies/mL (51 IU/mL) at Week 2451
Statistical analysis
  • Telbivudine vs Placebo · Fisher Exact · p = 1.0000 · Mean difference (net): -0.30 · 95% CI -37.03 to 36.75
SecondaryNumber of Patients Achieving HBV DNA< 300 Copies/mL (51 IU/mL) at Week 52 and Week 104

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.

Time frame:
Week 52, Week 104
Reported as:
Count of participants · Participants
Number of Patients Achieving HBV DNA< 300 Copies/mL (51 IU/mL) at Week 52 and Week 104
ParticipantsTelbivudinePlacebo
Week 5230
Week 1042—
SecondaryNumber of Patients Whose Baseline ALTs Were Abnormal and Subsequently Normalized at Week 24, 52 and 104

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.

Time frame:
Week 24, Week 52, Week 104
Reported as:
Count of participants · Participants
Number of Patients Whose Baseline ALTs Were Abnormal and Subsequently Normalized at Week 24, 52 and 104
ParticipantsTelbivudinePlacebo
Week 24120
Week 5211
Week 1042—
Statistical analysis
  • Telbivudine vs Placebo · Fisher Exact · p = 0.2984 · Mean difference (net): 32.43 · 95% CI -14.62 to 74.60Exact confidence interval for the difference in percentage. P-value from Fishers exact test comparing proportions in Initial LdT and Initial Placebo groups.
SecondaryNumber of Patients With HBeAg Loss, HBeAg Seroconversion at Week 24, 52 and 104

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.

Time frame:
Week 24, Week 52, Week 104
Reported as:
Count of participants · Participants
Number of Patients With HBeAg Loss, HBeAg Seroconversion at Week 24, 52 and 104
ParticipantsTelbivudinePlacebo
HBeAg loss at Week 2410
HBeAg seroconversion at Week 2410
HBeAg loss at Week 5210
HBeAg seroconversion at Week 5210
HBeAg loss at Week 1041—
HBeAg seroconversion at Week 1041—
Statistical analysis
  • Telbivudine vs Placebo · Fisher Exact · p = 1.0000 · Mean difference (net): 2.70 · 95% CI -53.70 to 60.20Exact confidence interval for the difference in percentage. P-value from Fishers exact test comparing proportions in Initial LdT and Initial Placebo groups.
  • Telbivudine vs Placebo · Fisher Exact · p = 1.0000 · Mean difference (net): 2.70 · 95% CI -53.70 to 60.20Exact confidence interval for the difference in percentage. P-value from Fishers exact test comparing proportions in Initial LdT and Initial Placebo groups.
SecondaryNumber of Patients With HBsAg Loss, HBsAg Seroconversion at Week 24, 52 and 104

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.

Time frame:
Week 24, Week 52, Week 104
Reported as:
Count of participants · Participants
Number of Patients With HBsAg Loss, HBsAg Seroconversion at Week 24, 52 and 104
ParticipantsTelbivudinePlacebo
HBsAg loss at Week 2410
HBsAg seroconversion at Week 2400
HBsAg loss at Week 5200
HBsAg seroconversion at Week 5200
HBsAg loss at Week 1040—
HBsAg seroconversion at Week 1040—
Statistical analysis
  • Telbivudine vs Placebo · Fisher Exact · p = 1.0000 · Mean difference (net): 2.44 · 95% CI -37.54 to 42.17Exact confidence interval for the difference in percentage. P-value from Fishers exact test comparing proportions in Initial LdT and Initial Placebo groups.
SecondaryNumber of Patients Achieving a Composite Endpoints (HBV DNA < 300 Copies/mL (51 IU/mL), ALT Normalization and HBeAg Seroconversion) at Week 52 and 104

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.

Time frame:
Week 52, Week 104
Reported as:
Count of participants · 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
ParticipantsTelbivudinePlacebo
Week 5210
Week 1041—
SecondaryNumber of Patients Achieving Cumulative Rate of Virological Breakthrough (VB) at Week 52 and 104

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.

Time frame:
Week 52, Week 104
Reported as:
Count of participants · Participants
Number of Patients Achieving Cumulative Rate of Virological Breakthrough (VB) at Week 52 and 104
ParticipantsTelbivudinePlacebo
Week 5210
Week 10410
SecondaryNumber 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

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)

Time frame:
Week 24
Reported as:
Count of participants · 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
ParticipantsTelbivudinePlacebo
Cumulative virological breakthrough00
Cumulative treatment emergent genotypic resistance10
Statistical analysis
  • Telbivudine vs Placebo · Fisher Exact · p = 1.0000 · Mean difference (net): 2.50 · 95% CI -37.05 to 41.83Exact confidence interval for the difference in percentage. P-value from Fishers exact test comparing proportions in Initial LdT and Initial Placebo groups.
SecondaryNumber of Participants With On-Treatments Adverse Events, Serious Adverse Events, and Death

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.

Time frame:
From first dose of study treatment to 30 days after last dose of study treatment, up to 112 weeks
Reported as:
Count of participants · Participants
Number of Participants With On-Treatments Adverse Events, Serious Adverse Events, and Death
ParticipantsTelbivudinePlacebo
On-treatment Adverse Event (AEs)204
On-treatment Serious Adverse Event (SAEs)00
On-treatment Deaths00

Adverse events

Collected over 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.. Non-serious events are listed at a 2% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Initial LdT (Telbivudine)0/43 (0%)0/43 (0%)20/43 (46.5%)
Initial Placebo on Placebo Treatment0/10 (0%)0/10 (0%)4/10 (40%)
Initial Placebo on LdT Treatment After Switching0/5 (0%)0/5 (0%)1/5 (20%)
All Ldt0/48 (0%)0/48 (0%)21/48 (43.8%)
Most frequent other events
Showing 10 of 25
Most frequent other events
EventInitial LdT (Telbivudine)Initial Placebo on Placebo TreatmentInitial Placebo on LdT Treatment After SwitchingAll Ldt
NasopharyngitisInfections and infestations0/430/101/51/48
HeadacheNervous system disorders6/431/100/56/48
Abdominal pain upperGastrointestinal disorders5/430/100/55/48
Ear painEar and labyrinth disorders0/431/100/50/48
NauseaGastrointestinal disorders0/431/100/50/48
TonsillitisInfections and infestations1/431/100/51/48
Upper respiratory tract infectionInfections and infestations1/431/100/51/48
Antibiotic prophylaxisSurgical and medical procedures0/431/100/50/48
Viral upper respiratory tract infectionInfections and infestations3/430/100/53/48
DiarrhoeaGastrointestinal disorders2/430/100/52/48

Baseline characteristics

Age, Continuous
Age, Continuous(Years)TelbivudinePlaceboTotal
Mean10.2 ± 4.889.1 ± 4.8910.0 ± 4.86
Sex: Female, Male
Sex: Female, Male(Participants)TelbivudinePlaceboTotal
Female14418
Male29635
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)TelbivudinePlaceboTotal
Caucasian401050
Black101
Asian202
HBV DNA
HBV DNA(log10 copies/mL)TelbivudinePlaceboTotal
Mean9.1 ± 1.148.2 ± 2.268.9 ± 1.43
Participants with alanine aminotransferase (ALT) - Multiples of upper limits of normal (ULN)
Participants with alanine aminotransferase (ALT) - Multiples of upper limits of normal (ULN)(Participants)TelbivudinePlaceboTotal
< 1 × ULN437
1 × - < 2 × ULN22426
2 × - < 5 × ULN16218
5 × or more ULN112
Participants with aspartate aminotransferase (AST) - Multiples of upper limits of normal (ULN)
Participants with aspartate aminotransferase (AST) - Multiples of upper limits of normal (ULN)(Participants)TelbivudinePlaceboTotal
< 1 × ULN26531
1 × - < 2 × ULN14418
2 × - < 5 × ULN202
5 × or more ULN112
08

Study locations

29 sites
  • Novartis Investigative Site
    Sofia, Sofia-Grad 1700, Bulgaria
  • Novartis Investigative Site
    Pleven, 5800, Bulgaria
  • Novartis Investigative Site
    Sofia, 1407, Bulgaria
  • Novartis Investigative Site
    Varna, 9010, Bulgaria
  • Novartis Investigative Site
    Goudi-Athens, GR 115 27, Greece
  • Novartis Investigative Site
    Athens, 12462, Greece
  • Novartis Investigative Site
    Jerusalem, 91031, Israel
  • Novartis Investigative Site
    Jerusalem, 91120, Israel
  • Novartis Investigative Site
    Nahariya, 22100, Israel
  • Novartis Investigative Site
    Nazareth, 16100, Israel
  • Novartis Investigative Site
    Seoul, Korea 05505, Korea, Republic of
  • Novartis Investigative Site
    Cluj Napoca, Cluj 400177, Romania
  • Novartis Investigative Site
    Craiova, Dolj 200515, Romania
  • Novartis Investigative Site
    Timisoara, Jud. Timis 300011, Romania
  • Novartis Investigative Site
    Bucharest, 011743, Romania
  • Novartis Investigative Site
    Bucharest, 021105, Romania
  • Novartis Investigative Site
    Bucharest, 022328, Romania
  • Novartis Investigative Site
    Iasi, 700309, Romania
  • Novartis Investigative Site
    Ankara, 06100, Turkey
  • Novartis Investigative Site
    Antalya, 07070, Turkey
  • Novartis Investigative Site
    Diyarbakir, 21000, Turkey
  • Novartis Investigative Site
    Elazig, 23119, Turkey
  • Novartis Investigative Site
    Eskisehir, 26040, Turkey
  • Novartis Investigative Site
    Mersin, 33343, Turkey
  • Novartis Investigative Site
    Dnipropetrovsk, 49006, Ukraine
  • Novartis Investigative Site
    Kiev, Ukraine
  • Novartis Investigative Site
    Kyiv, 04119, Ukraine
  • Novartis Investigative Site
    Odesa, 65031, Ukraine
  • Novartis Investigative Site
    Vinnytsia, 21029, Ukraine
09

References and documents

Study documents

  • Study protocol · Nov 22, 2016
  • Statistical analysis plan · Sep 25, 2017

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 10, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02058108
Lead sponsor
Novartis Pharmaceuticals
Responsible party
Sponsor
First posted
Feb 7, 2014
Start date
Oct 31, 2014
Primary completion
Jan 9, 2019
Completion
Jan 9, 2019
Results posted
Sep 10, 2019
Last update
Sep 10, 2019

Study contacts

Novartis Pharmaceuticals
study director · Novartis Pharmaceuticals

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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