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 sites28 target enrollmentSeptember 5, 2008

Overview

No summary available.

Registry

who.int

Start Date

September 5, 2008

End Date

TBD

Last Updated

13 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•?• Subjects 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.
•Subjects must be between the ages of 2 to 18 years with body weight within 15% of normal relative to age, based on either the Centers for Disease Control and Prevention (CDC) growth chart or national health service norms.
•The subject must have documented HBV infection with both:
•\- Positive HBsAg assay at Screening;
•\- Positive serum HBV DNA at Screening
•Subjects 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\).
•All female subjects of reproductive potential must have negative serum pregnancy test at Screening and negative urine pregnancy test on Day –1\.
•All subjects of reproductive potential must agree to use appropriate barrier method of birth control or agree to abstain from intercourse from Day –1 through Day 30 after dosing.
•Subjects 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 subject’s safety or interfere with study endpoints.
•Subjects must agree not to consume alcohol within two days of reporting to the clinic on Day –1\.

•?• Decompensated liver disease (Child\-Turcotte\-Pugh (CTP) Score\=7, Class B and C)
•Subjects with a positive Screening result for hepatitis C virus (HCV), hepatitis D virus (HDV), or HIV type 1 or 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 females
•\- Absolute neutrophil count (ANC) \<1,500/mm3
•\- Platelet count \< 120,000/mm3
•\- White blood cell count (WBC) \<3 x 109/L (\<3,000/mm3\)
•\- Prothrombin time 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;