Ignite Creation Date:
2025-12-24 @ 7:10 PM
Ignite Modification Date:
2026-01-02 @ 5:06 PM
Study NCT ID:
NCT00230503
Status:
COMPLETED
Last Update Posted:
2012-06-22
First Post:
2005-09-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dose-Ranging Study of Pradefovir in Patients With Compensated Hepatitis B
Sponsor:
Bausch Health Americas, Inc.
Organization:
Study Overview
Official Title:
Dose-Ranging Study of Pradefovir in Patients With Compensated Hepatitis B
Status:
COMPLETED
Status Verified Date:
2012-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
* Compare the safety of four oral doses of pradefovir after 48 weeks of treatment
* Select the dose of pradefovir for Phase 3 studies
* 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
* 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
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: