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 Infectio
- Conditions
- Chronic hepatitis BMedDRA version: 9.1 Level: LLT Classification code 10008910 Term: Chronic hepatitis B
- Registration Number
- EUCTR2007-006218-40-GB
- Lead Sponsor
- ovartis Pharma Services AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 23
?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
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
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
females
• 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)
• Total bilirubin (=2.0 mg/dL or =34.2 µmol/L);
• Serum ALT level >10 x ULN.
• Blood urea nitrogen (BUN) greater than the upper limit of normal.
3 Participation in a clinical drug study within 30 days of Screening.
4 Treatment with interferon within six months of Screening.
5 Treatment with nucleoside/nucleotide reverse transcriptase inhibitors within three months of Screening.
6 Treatment with any other anti-HBV drugs or other antiviral therapy (e.g., acyclovir
ganciclovir) within 30 days of study drug dosing.
7 Treatment with antibiotics within 7 days of Screening.
8 Females who are pregnant or are breast-feeding.
9 Patients 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> Main Objective: ?• To evaluate the single-dose pharmacokinetics of LDT600 in pediatric and<br> adolescent patients (2-18 years of age) with chronic hepatitis B<br> (CHB) infection<br> • To evaluate the safety and tolerability of LDT600 in pediatric and<br> adolescent patients with CHB infection<br> ;Secondary Objective: ;<br> Primary end point(s): ?• LDT600 plasma concentration and pharmacokinetic (PK) parameters of<br> exposure (Cmax and AUC)<br> • Incidence of adverse events (AEs) and serious adverse events (SAEs).<br>
- Secondary Outcome Measures
Name Time Method