EUCTR2007-006218-40-Outside-EU/EEAActive, not recruitingNot Applicable
A Phase I, Open-label, Single-Dose Study to Evaluate the Pharmacokinetics and Safety of Telbivudine (LdT) in Children and Adolescents with Chronic Hepatitis B Virus InfectionEMA decision numbers on this PIP:P/111/2008, P/119/2010, P/203/2011
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- ovartis Pharma Services AG
- Enrollment
- 28
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •Children and adolescents patients
- •HBsAg seropositive
- •Other protocol-defined inclusion/exclusion criteria may apply.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 28
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
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.
Investigators
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