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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):

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.

Condition or disease Intervention/treatment Phase
Chronic Hepatitis B Drug: LDT600 (Telbivudine) Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
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 Start Date : February 2009
Primary Completion Date : March 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Telbivudine
U.S. FDA Resources

Arms and Interventions

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)


Outcome Measures

Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00907894


Locations
Belgium
Novartis Investigative Site
Brussels, Belgium
Germany
Novartis Investigator Site
Frankfurt, Germany
Novartis Investigator Site
Starnberg, Germany
Novartis Investigator Site
Wuppertal, Germany
Philippines
Novartis Investigator Site
Manila, Philippines
Novartis Investigator Site
Quezon City, Philippines
United Kingdom
Novartis Investigator Site
Birmingham, United Kingdom
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00907894     History of Changes
Other Study ID Numbers: CLDT600A2104
EudraCT 2007-006218-40
First Posted: May 25, 2009    Key Record Dates
Last Update Posted: September 27, 2012
Last Verified: September 2012

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Chronic hepatitis B,
telbivudine,
pharmacokinetics,
safety,
tolerability,
pediatric

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis B
Hepatitis B, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Telbivudine
Antiviral Agents
Anti-Infective Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action