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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00907894
First received: May 22, 2009
Last updated: September 26, 2012
Last verified: September 2012

May 22, 2009
September 26, 2012
February 2009
March 2012   (final data collection date for primary outcome measure)
LDT600 plasma concentration and pharmacokinetic (PK) parameters of exposure (Cmax and AUC) [ Time Frame: 6 days ] [ Designated as safety issue: Yes ]
To evaluate the single-dose pharmacokinetics of LDT600 in pediatric and adolescent patients (2-18 years of age) with chronic hepatitis B (CHB) infection.
To evaluate the single-dose pharmacokinetics of LDT600 in pediatric and adolescent patients (2-18 years of age) with chronic hepatitis B (CHB) infection. Measure: LDT600 plasma concentration and pharmacokinetic (PK) parameters of exposure (Cmax and AUC) [ Time Frame: 6 days ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00907894 on ClinicalTrials.gov Archive Site
Safety assessments will include vital signs, ECG and incidence of adverse events and serious adverse events. [ Time Frame: 6 days ] [ Designated as safety issue: Yes ]
To evaluate the safety and tolerability of LDT600 in pediatric and adolescent patients with chronic hepatitis B infection
To evaluate the safety and tolerability of LDT600 in pediatric and adolescent patients with chronic hepatitis B infection. Measure: Safety assessments will include vital signs, ECG and adverse events, incidence of adverse events and serious [ Time Frame: 6 days ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Chronic Hepatitis B
Drug: LDT600 (Telbivudine)
LDT600 (Telbivudine)
  • Experimental: Stratum 1
    Intervention: Drug: LDT600 (Telbivudine)
  • Experimental: Stratum 2
    Intervention: Drug: LDT600 (Telbivudine)
  • Experimental: Stratum 3
    Intervention: Drug: LDT600 (Telbivudine)
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
22
Not Provided
March 2012   (final data collection date for primary outcome measure)

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.

Both
2 Years to 18 Years
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   Germany,   Philippines,   United Kingdom
 
NCT00907894
CLDT600A2104, EudraCT 2007-006218-40
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP