Pharmacokinetics and Safety of Single-Dose Telbivudine in Children and Adolescents With Chronic Hepatitis B
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
2 other identifiers
interventional
22
4 countries
7
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2009
CompletedFirst Submitted
Initial submission to the registry
May 22, 2009
CompletedFirst Posted
Study publicly available on registry
May 25, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2012
CompletedDecember 19, 2020
September 1, 2012
3.1 years
May 22, 2009
December 16, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
LDT600 plasma concentration and pharmacokinetic (PK) parameters of exposure (Cmax and AUC)
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 Outcomes (1)
Safety assessments will include vital signs, ECG and incidence of adverse events and serious adverse events.
6 days
Study Arms (3)
Stratum 1
EXPERIMENTALStratum 2
EXPERIMENTALStratum 3
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Children and adolescents patients
- HBsAg seropositive
You may not qualify if:
- Decompensated liver disease (Child-Turcotte-Pugh (CTP) Score≥7, Class B and C)
- Prior anti-HBV therapy within 30 days of study drug dosing.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Novartis Investigative Site
Brussels, Belgium
Novartis Investigator Site
Frankfurt, Germany
Novartis Investigator Site
Starnberg, Germany
Novartis Investigator Site
Wuppertal, Germany
Novartis Investigator Site
Manila, Philippines
Novartis Investigator Site
Quezon City, Philippines
Novartis Investigator Site
Birmingham, United Kingdom
Related Publications (1)
Stein DS, Ke J, Uy G, Bosheva M, Qi Y, Praestgaard J; LDT600A2104 Study Team. Phase I, open-label, single-dose study to evaluate the pharmacokinetics and safety of telbivudine in children and adolescents with chronic hepatitis B. Antimicrob Agents Chemother. 2013 Sep;57(9):4128-33. doi: 10.1128/AAC.00117-13. Epub 2013 Jun 17.
PMID: 23774433DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 22, 2009
First Posted
May 25, 2009
Study Start
February 1, 2009
Primary Completion
March 1, 2012
Last Updated
December 19, 2020
Record last verified: 2012-09