Back to resultsPharmacokinetics and Safety of Single-Dose Telbivudine in Children and Adolescents With Chronic Hepatitis B
Primary Purpose
Chronic Hepatitis B
Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
LDT600 (Telbivudine)
Sponsored by
About this trial
This is an interventional other trial for Chronic Hepatitis B focused on measuring Chronic hepatitis B,, telbivudine,, pharmacokinetics,, safety,, tolerability,, pediatric
Eligibility Criteria
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.
Sites / Locations
- Novartis Investigative Site
- Novartis Investigator Site
- Novartis Investigator Site
- Novartis Investigator Site
- Novartis Investigator Site
- Novartis Investigator Site
- Novartis Investigator Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Stratum 1
Stratum 2
Stratum 3
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Safety assessments will include vital signs, ECG and incidence of adverse events and serious adverse events.
To evaluate the safety and tolerability of LDT600 in pediatric and adolescent patients with chronic hepatitis B infection
Full Information
NCT ID
NCT00907894
First Posted
May 22, 2009
Last Updated
December 16, 2020
Sponsor
Novartis Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT00907894
Brief Title
Pharmacokinetics and Safety of Single-Dose Telbivudine in Children and Adolescents With Chronic Hepatitis B
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis B
Keywords
Chronic hepatitis B,, telbivudine,, pharmacokinetics,, safety,, tolerability,, pediatric
7. Study Design
Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Stratum 1
Arm Type
Experimental
Arm Title
Stratum 2
Arm Type
Experimental
Arm Title
Stratum 3
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
LDT600 (Telbivudine)
Intervention Description
LDT600 (Telbivudine)
Primary Outcome Measure Information:
Title
LDT600 plasma concentration and pharmacokinetic (PK) parameters of exposure (Cmax and AUC)
Description
To evaluate the single-dose pharmacokinetics of LDT600 in pediatric and adolescent patients (2-18 years of age) with chronic hepatitis B (CHB) infection.
Time Frame
6 days
Secondary Outcome Measure Information:
Title
Safety assessments will include vital signs, ECG and incidence of adverse events and serious adverse events.
Description
To evaluate the safety and tolerability of LDT600 in pediatric and adolescent patients with chronic hepatitis B infection
Time Frame
6 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative Site
City
Brussels
Country
Belgium
Facility Name
Novartis Investigator Site
City
Frankfurt
Country
Germany
Facility Name
Novartis Investigator Site
City
Starnberg
Country
Germany
Facility Name
Novartis Investigator Site
City
Wuppertal
Country
Germany
Facility Name
Novartis Investigator Site
City
Manila
Country
Philippines
Facility Name
Novartis Investigator Site
City
Quezon City
Country
Philippines
Facility Name
Novartis Investigator Site
City
Birmingham
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
23774433
Citation
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.
Results Reference
derived
Links:
URL
https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=7003
Description
Results for CLDT600A2104 can be found on the Novartis Clinical Trial Results Website
Learn more about this trial
Pharmacokinetics and Safety of Single-Dose Telbivudine in Children and Adolescents With Chronic Hepatitis B
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