Evaluate Efficacy, Safety and PK of Adefovir Dipivoxil Liquid Suspension in Patients With Chronic Hepatitis B

Phase 3

Completed

• Conditions: Chronic Hepatitis B

• Registration Number: NCT00071201
• Lead Sponsor: Gilead Sciences

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 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.

Study Timeline

• Study Start: 2003-06
• Study First Submitted: 2003-10-15
• Study First Submitted QC: 2003-10-16
• Study First Posted: 2003-10-17
• Primary Completion: 2006-03
• Study Completion: 2006-03
• Status Verified: 2013-10
• Last Update Submitted: 2013-10-14
• Last Update Posted: 2013-10-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Trial Locations

Locations (1)

Gilead Sciences, Inc. 333 Lakeside Drive; 🇺🇸 Foster City, California, United States