NCT00230503

Dose-Ranging Study of Pradefovir in Patients With Compensated Hepatitis B

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 220 (planned)
• Sponsor: Bausch Health Americas, Inc. · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

* Compare the safety of four oral doses of pradefovir after 48 weeks of treatment * Select the dose of pradefovir for Phase 3 studies

Detailed description

* Compare the safety of four oral doses of pradefovir after 48 weeks of treatment * Compare the antiviral activity of four oral doses of pradefovir to adefovir and dipivoxyl after 48 weeks of treatment * Select the dose of pradefovir for Phase 3 studies * Determine the pharacokinetic profiles of four oral doses of pradefovir

Conditions

• Hepatitis B, Chronic

Interventions

Type	Name	Description
DRUG	pradefovir mesylate
DRUG	adefovir dipivoxyl

Timeline

• Start date: 2004-06-01
• Primary completion: 2006-12-01
• Completion: 2006-12-01
• First posted: 2005-09-30
• Last updated: 2012-06-22