Ignite Creation Date:
2024-05-05 @ 12:05 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00230490
Status:
TERMINATED
Last Update Posted:
2019-11-29
First Post:
2005-09-28
Brief Title:
Open-label Treatment Extension Study for Patients Who Complete Study RNA200103-201
Sponsor:
Bausch Health Americas Inc
Organization:
Bausch Health Americas Inc
Study Overview
Official Title:
Open-label Treatment Extension Study for Patients Who Complete Study RNA200103-201
Status:
TERMINATED
Status Verified Date:
2019-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Adverse findings from nonclinical carcinogenicity studies
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Compare the long-term safety of pradefovir to adefovir dipivoxyl
Detailed Description:
Compare the long-term safety of pradefovir to adefovir dipivoxyl
Monitor development of resistance
Evaluate virologic and biochemical response
Monitor development of resistance
Evaluate virologic and biochemical response
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