Pharmacokinetics and Safety of Single-Dose Telbivudine in Children and Adolescents With Chronic Hepatitis B

December 16, 2020 updated by: Novartis Pharmaceuticals

A Phase I, Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics and Safety of Telbivudine (LDT600) in Children and Adolescents With Chronic Hepatitis B

This is a Phase I, open-label, single-dose study to evaluate the pharmacokinetics and safety of LDT600 in pediatric and adolescent patients with chronic hepatitis B infection.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium
        • Novartis Investigative Site
  • Germany
      • Frankfurt, Germany
        • Novartis Investigator Site
      • Starnberg, Germany
        • Novartis Investigator Site
      • Wuppertal, Germany
        • Novartis Investigator Site
  • Philippines
      • Manila, Philippines
        • Novartis Investigator Site
      • Quezon City, Philippines
        • Novartis Investigator Site
  • United Kingdom
      • Birmingham, United Kingdom
        • Novartis Investigator Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Children and adolescents patients
  • HBsAg seropositive

Exclusion criteria:

  • Decompensated liver disease (Child-Turcotte-Pugh (CTP) Score≥7, Class B and C)
  • Prior anti-HBV therapy within 30 days of study drug dosing.

Other protocol-defined inclusion/exclusion criteria may apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Stratum 1
Drug: LDT600 (Telbivudine)
LDT600 (Telbivudine)
Experimental: Stratum 2
Drug: LDT600 (Telbivudine)
LDT600 (Telbivudine)
Experimental: Stratum 3
Drug: LDT600 (Telbivudine)
LDT600 (Telbivudine)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
LDT600 plasma concentration and pharmacokinetic (PK) parameters of exposure (Cmax and AUC)
Time Frame: 6 days
To evaluate the single-dose pharmacokinetics of LDT600 in pediatric and adolescent patients (2-18 years of age) with chronic hepatitis B (CHB) infection.
6 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety assessments will include vital signs, ECG and incidence of adverse events and serious adverse events.
Time Frame: 6 days
To evaluate the safety and tolerability of LDT600 in pediatric and adolescent patients with chronic hepatitis B infection
6 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (Actual)

March 1, 2012

Study Registration Dates

First Submitted

May 22, 2009

First Submitted That Met QC Criteria

May 22, 2009

First Posted (Estimate)

May 25, 2009

Study Record Updates

Last Update Posted (Actual)

December 19, 2020

Last Update Submitted That Met QC Criteria

December 16, 2020

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLDT600A2104
  • EudraCT 2007-006218-40

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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