Pharmacokinetics and Safety of Single-Dose Telbivudine in Children and Adolescents With Chronic Hepatitis B
Phase 1
Completed
- Conditions
- Chronic Hepatitis B
- Interventions
- Drug: LDT600 (Telbivudine)
- Registration Number
- NCT00907894
- Lead Sponsor
- Novartis Pharmaceuticals
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 22
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 Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Stratum 1 LDT600 (Telbivudine) - Stratum 3 LDT600 (Telbivudine) - Stratum 2 LDT600 (Telbivudine) -
- Primary Outcome Measures
Name Time Method LDT600 plasma concentration and pharmacokinetic (PK) parameters of exposure (Cmax and AUC) 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
Name Time Method Safety assessments will include vital signs, ECG and incidence of adverse events and serious adverse events. 6 days To evaluate the safety and tolerability of LDT600 in pediatric and adolescent patients with chronic hepatitis B infection
Trial Locations
- Locations (2)
Novartis Investigative Site
🇧🇪Brussels, Belgium
Novartis Investigator Site
🇬🇧Birmingham, United Kingdom