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

> **NCT02058108** · PHASE3 · TERMINATED · sponsor: **Novartis Pharmaceuticals** · enrollment: 53 (actual)

## Conditions studied

- Chronic Hepatitis B

## Interventions

- **DRUG:** Telbivudine
- **DRUG:** Placebo

## Key facts

- **NCT ID:** NCT02058108
- **Lead sponsor:** Novartis Pharmaceuticals
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** TERMINATED
- **Start date:** 2014-10-31
- **Primary completion:** 2019-01-09
- **Final completion:** 2019-01-09
- **Target enrollment:** 53 (ACTUAL)
- **Why stopped:** Study terminated on the recommendation of an independent Data Monitoring Committee (DMC) subsequent to an interim efficacy analysis for futility.\]
- **Last updated:** 2019-09-10


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT02058108

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT02058108, "Study of Efficacy and Safety, Tolerability and Pharmacokinetics of Telbivudine in Children and Adolescents With Compensated Chronic Hepatitis B Virus Infection". Retrieved via AI Analytics 2026-05-28 from https://api.ai-analytics.org/clinical/NCT02058108. Licensed CC0.

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*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*