Chronic Hepatitis B Clinical Trial
Official title:
A Multi-Center Phase 3, Open-Label, Parallel-Group Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Adefovir Dipivoxil Liquid Suspension in Patients With Chronic Hepatitis B and Varying Degrees of Renal Impairment
This is a multi-center phase 3, open-label, parallel-group study designed to evaluate the efficacy, safety and pharmacokinetics of adefovir dipivoxil liquid suspension in patients with chronic hepatitis B and varying degrees of renal impairment.
Approximately 48 patients with chronic hepatitis B will be enrolled into four groups
representing varying degrees of renal function. Grouping will be achieved through estimation
of creatinine clearance (CLcr) using the Cockcroft-Gault method of calculation at the time
of screening:
Group 1: Mild (Clcr = greater than or equal to 50 to less than 80 mL/min)
Group 2: Moderate (Clcr = greater than or equal to 20 to less than 50 mL/min)
Group 3: Severe (Clcr = greater than or equal to 10 to less than 20 mL/min)
Group 4A-B: End stage renal disease (ESRD) including hemodialysis:
- Group 4A (Clcr = less than 10 mL/min)
- Group 4B (Patients undergoing hemodialysis)
At the baseline visit (day 0), blood and urine samples will be collected pre-dose (prior to
0 hour) after which patients will receive an oral dose of liquid adefovir dipivoxil
according to the treatment guideline outlined in the protocol.
Pharmacokinetic parameters in plasma will be determined for the day 0 and week 12 visits for
all patients and at the week 48 visit for group 1, 2, 3, and 4A patients. Pharmacokinetic
parameters in urine will be determined for the day 0, week 12 and week 48 visits for group
1, 2, 3, and 4A patients.
At week 4, 8, 16, 20, 24, 28, 32, 36, 40, and 44 visits, pharmacokinetic assessments in
plasma will be determined pre-dose (Ctrough levels) in groups 1, 2, 3, and 4A. For group 4B
patients, pharmacokinetic assessments will be determined at weeks 4 and 8 prior to and upon
completion of hemodialysis.
Evaluations of safety and efficacy will be conducted at 4 weekly intervals up to week 48 for
groups 1, 2, 3, and 4A, and up to week 12 for group 4B. At these visits, patients will
receive the next study medication allocation. Study medication administration will continue
for up to a total of 48 weeks.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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