Chronic hepatitis B MedDRA version: 9.1 Level: LLT Classification code 10008910 Term: Chronic hepatitis B
Conditions
Interventions
Product Name: Telbivudine
Product Code: LDT600A
Pharmaceutical Form: Oral solution
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 20-
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ?• 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. Are the trial subjects under 18? yes Number of subjects for this age range: 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
Exclusion criteria: ?• 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 50 ng/mL. - Serum ALT level >10 x ULN. - Blood urea nitrogen (BUN) within normal limits. • Participation in a clinical drug study within 30 days of Screening. • Treatment with interferon within six months of Screening. • Treatment with nucleoside/nucleotide reverse transcriptase inhibitors within three months of Screening. • Treatment with any other anti-HBV drugs or other antiviral therapy (e.g., acyclovir ganciclovir) within 30 days of study drug dosing. • Treatment with antibiotics within 7 days of Screening. • Females who are pregnant or are breast-feeding. • Subjects who are currently abusing alcohol or illicit drugs, or have a history of such abuse within the preceding two years. For the purposes of the present study, alcohol abuse is arbitrarily defined as frequent consumption of alcoholic beverages with an average daily intake of more than 40 g of alcohol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: ?• To evaluate the single-dose pharmacokinetics of LDT600 in pediatric and adolescent patients (2-18 years of age) with chronic hepatitis B (CHB) infection • To evaluate the safety and tolerability of LDT600 in pediatric and adolescent patients with CHB infection ;Secondary Objective: ;Primary end point(s): ?• LDT600 plasma concentration and pharmacokinetic (PK) parameters of exposure (Cmax and AUC) • Incidence of adverse events (AEs) and serious adverse events (SAEs). | — |
Countries
Belgium, Bulgaria, Germany, United Kingdom
Outcome results
None listed