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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00907894
Recruitment Status : Completed
First Posted : May 25, 2009
Last Update Posted : September 27, 2012
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Tracking Information
First Submitted Date  ICMJE May 22, 2009
First Posted Date  ICMJE May 25, 2009
Last Update Posted Date September 27, 2012
Study Start Date  ICMJE February 2009
Actual Primary Completion Date March 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 28, 2012)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 22, 2009)
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 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 28, 2012)
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
Original Secondary Outcome Measures  ICMJE
 (submitted: May 22, 2009)
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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pharmacokinetics and Safety of Single-Dose Telbivudine in Children and Adolescents With Chronic Hepatitis B
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Condition  ICMJE Chronic Hepatitis B
Intervention  ICMJE Drug: LDT600 (Telbivudine)
LDT600 (Telbivudine)
Study Arms  ICMJE
  • Experimental: Stratum 1
    Intervention: Drug: LDT600 (Telbivudine)
  • Experimental: Stratum 2
    Intervention: Drug: LDT600 (Telbivudine)
  • Experimental: Stratum 3
    Intervention: Drug: LDT600 (Telbivudine)
Publications * 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.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 26, 2012)
22
Original Estimated Enrollment  ICMJE
 (submitted: May 22, 2009)
28
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date March 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Germany,   Philippines,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00907894
Other Study ID Numbers  ICMJE CLDT600A2104
EudraCT 2007-006218-40
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Novartis ( Novartis Pharmaceuticals )
Study Sponsor  ICMJE Novartis Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
PRS Account Novartis
Verification Date September 2012

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