Single-Dose Study to Evaluate Telbivudine in Children with Hepatitis B

• Research type

  Research Study

• Full title

  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.

• IRAS ID

  6072

• Sponsor organisation

  Novartis Pharmaceuticals

• Eudract number

  2007-006218-40

• ISRCTN Number

  N/A

• Research summary

  This is a single-dose study to investigate the pharmacokinetics (how the drug is treated by the body) and safety of telbuvidine in young patients with Chronic Hepatitis B infection (HBV). The patients range from 2 to 18 years of age and will be organised into three different groups for treatment; 2-6 years old (contains 12 patients), 7-12 years old (contains 8 patients) and 13-18 years old (contains 8 patients). Patients in the first two groups will receive a single dose of 15 or 25 mg/kg telbuvidine as an oral solution (OS), given by mouth. Total dose will not be more than 600mg. At the beginning, adolescent subjects in group 3 will receive a single dose of 600 mg dose. Then, the 15mg/kg dose will be administered first to half of the first group (6 out of 12) and half of the second group (4 out of 8). After looking at the safety data from this dose the remaining 6 patients in the first group and remaining 4 patients in the second group will receive the 25mg/kg dose.Telbuvidine in the form of a pill has already been approved for use in adults in the US, there is a vaccine available for the treatment of HBV but it is not 100% effective and every child does not receive the vaccine. Telbuvidine has shown promising anti-HBV efficacy and acceptable tolerance in adult clinical trials. This study is to extend the understanding of the break down of the drug telbuvidine in young children and adolescent patients, results from this study will assist in showing the safest dosage that can be used in a large-scale trial designed to examine the long-term efficacy and safety in these populations.

• REC name

  West Midlands - Edgbaston Research Ethics Committee

• REC reference

  09/H1208/11

• Date of REC Opinion

  6 May 2009

• REC opinion

  Further Information Favourable Opinion