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 Infection

ovartis Pharma Services AG0 sites23 target enrollmentNovember 5, 2008

Overview

No summary available.

Registry

who.int

Start Date

November 5, 2008

End Date

November 27, 2011

Last Updated

6 years ago

Study Type

Interventional clinical trial of medicinal product

Sponsor

•?1 ?Patients or legal guardian must have read and signed the written informed consent form (ICF) after the nature of the study has been fully explained and all questions answered.
•2 Patients must be between the ages of 2 to 18 years with body weight within 15th to 85th percentile of normal relative to age, based on either the Centers for Disease Control and Prevention (CDC) growth chart (Appendix 1\) or national health service norms.
•3 The patient must have documented chronic HBV (CHB) infection with positive HBsAg
•assay at Screening.
•4 Patients must have a screening creatinine clearance (CLcr) \= 80 mL/min/1\.73 m2 as estimated by the Schwartz formula (See Section 8\.2\.2\.1\).
•5 All female patients of reproductive potential must have negative serum pregnancy test at Screening and negative urine pregnancy test on Day –1\.
•6 All patients of reproductive potential must agree to use appropriate double barrier method of birth control or agree to abstain from intercourse from Day –1 through Day 30 after dosing.
•7 Patients must agree not to take any other medications during the course of the study, without the approval of the Investigator, who in consultation with the Sponsor, may permit its use, on a case\-by\-case basis, when it is judged not to jeopardize the patient’s safety or interfere with study endpoints.
•8 Patients must agree not to consume alcohol within two days of reporting to the clinic on Day –1\.
•Are the trial subjects under 18? yes

•1 Decompensated liver disease (Child\-Turcotte\-Pugh (CTP) Score\=7, Class B and C)
•2 Other clinically significant disease, condition or abnormality, unrelated to their HBV
•infection, as assessed by the Investigator, based on medical history, physical examination, 12\-lead electrocardiogram (ECG), or clinical laboratory testing, including:
•Hemoglobin value \<110 g/L (11\.0 g/dL) for males and \<100 g/L (10\.0 g/dL) for
•Absolute neutrophil count (ANC) (\<1,500/ x 10E3\) (\<1\.5x10E9\)
•Platelet count (\< 120,000/ x10E3\) (\<120 x10E9\)
•White blood cell count (WBC) (\<3,000/ x10E3\) (3\.0 x10E9\)
•Prothrombin time/INR prolonged by more than 3 seconds, (based on the Upper Limit Normal \[ULN]; of the reference value)
•Serum amylase or lipase \=1\.5 x ULN;
•Serum albumin (\<3\.5 g/dL); (\<35 g/L)