Status:
COMPLETED
Pharmacokinetics and Safety of Single-Dose Telbivudine in Children and Adolescents With Chronic Hepatitis B
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Chronic Hepatitis B
Eligibility:
All Genders
2-18 years
Phase:
PHASE1
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.
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT00907894
Start Date
February 1 2009
Last Update
December 19 2020
Active Locations (7)
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1
Novartis Investigative Site
Brussels, Belgium
2
Novartis Investigator Site
Frankfurt, Germany
3
Novartis Investigator Site
Starnberg, Germany
4
Novartis Investigator Site
Wuppertal, Germany