Ignite Creation Date:
2024-05-05 @ 11:32 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00071201
Status:
COMPLETED
Last Update Posted:
2013-10-16
First Post:
2003-10-15
Brief Title:
Evaluate Efficacy Safety and PK of Adefovir Dipivoxil Liquid Suspension in Patients With Chronic Hepatitis B
Sponsor:
Gilead Sciences
Organization:
Gilead Sciences
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2013-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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 mLmin
Group 2 Moderate Clcr greater than or equal to 20 to less than 50 mLmin
Group 3 Severe Clcr greater than or equal to 10 to less than 20 mLmin
Group 4A-B End stage renal disease ESRD including hemodialysis
Group 4A Clcr less than 10 mLmin
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
Group 1 Mild Clcr greater than or equal to 50 to less than 80 mLmin
Group 2 Moderate Clcr greater than or equal to 20 to less than 50 mLmin
Group 3 Severe Clcr greater than or equal to 10 to less than 20 mLmin
Group 4A-B End stage renal disease ESRD including hemodialysis
Group 4A Clcr less than 10 mLmin
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None