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

This study has been completed.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals ) Identifier:
First received: May 22, 2009
Last updated: September 26, 2012
Last verified: September 2012
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 Intervention Phase
Chronic Hepatitis B
Drug: LDT600 (Telbivudine)
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

Further study details as provided by Novartis ( Novartis Pharmaceuticals ):

Primary Outcome Measures:
  • 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:
  • 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

Enrollment: 22
Study Start Date: February 2009
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Stratum 1 Drug: LDT600 (Telbivudine)
LDT600 (Telbivudine)
Experimental: Stratum 2 Drug: LDT600 (Telbivudine)
LDT600 (Telbivudine)
Experimental: Stratum 3 Drug: LDT600 (Telbivudine)
LDT600 (Telbivudine)


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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00907894

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
United Kingdom
Novartis Investigator Site
Birmingham, United Kingdom
Sponsors and Collaborators
Novartis Pharmaceuticals
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Novartis Pharmaceuticals Identifier: NCT00907894     History of Changes
Other Study ID Numbers: CLDT600A2104
EudraCT 2007-006218-40
Study First Received: May 22, 2009
Last Updated: September 26, 2012

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Chronic hepatitis B,

Additional relevant MeSH terms:
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
Antiviral Agents
Anti-Infective Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on May 25, 2017