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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
History of Changes
  Purpose

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:

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


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)

  Eligibility

Ages Eligible for Study:   2 Years to 18 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov 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
Health Authority: United States: Food and Drug Administration
Belgium: Federal Agency for Medicinal Products and Health Products
Germany: Federal Institute for Drugs and Medical Devices
Philippines: Department of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Bulgaria: Bulgarian Drug Agency
Egypt: Ministry of Health, Drug Policy and Planning Center

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

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Hepatitis, Chronic
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

ClinicalTrials.gov processed this record on May 21, 2013