Viewing Study NCT00496158



Ignite Creation Date: 2024-05-05 @ 6:32 PM
Last Modification Date: 2024-10-26 @ 9:34 AM
Study NCT ID: NCT00496158
Status: TERMINATED
Last Update Posted: 2009-04-27
First Post: 2007-07-02

Brief Title: Efficacy and Safety of Clevudine Compared With Adefovir in Patients With Chronic Hepatitis Due to Hepatitis B Virus
Sponsor: Pharmasset
Organization: Pharmasset

Study Overview

Official Title: A Multi-Center Randomized Double-Blind Active-Control 96 Week Phase III Trial of the Efficacy and Safety of Clevudine Compared With Adefovir at Weeks 48 and 96 in Nucleoside Treatment-Naïve Patients With HBeAg Negative Chronic Hepatitis Due to Hepatitis B Virus
Status: TERMINATED
Status Verified Date: 2009-04
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: The study was terminated in the interest of patient safety
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: QUASH2
Brief Summary: The objectives of this study are to compare in nucleoside treatment-naïve subjects the efficacy and safety of clevudine 30 mg once daily versus adefovir 10 mg once daily each as monotherapy for 48 weeks 72 weeks and 96 weeks
Detailed Description: None

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