Ignite Creation Date:
2024-05-06 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 1:53 PM
Study NCT ID:
NCT04697810
Status:
RECRUITING
Last Update Posted:
2023-06-18
First Post:
2021-01-04
Brief Title:
Namodenoson in the Treatment of Non-Alcoholic Steatohepatitis NASH
Sponsor:
Can-Fite BioPharma
Organization:
Can-Fite BioPharma
Study Overview
Official Title:
A Phase 2B Randomized Double-Blind Placebo-Controlled Study of the Efficacy and Safety of Namodenoson in the Treatment of Non-Alcoholic Steatohepatitis NASH
Status:
RECRUITING
Status Verified Date:
2024-07
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:
Subjects with biopsy-proven NASH will be randomly assigned in a 21 ratio to oral doses of namodenoson 25 mg every 12 hours or matching placebo every 12 hours for 36 weeks Subjects will be evaluated regularly for safety and efficacy biomarkers will be measured at Baseline and Weeks 6 12 24 and 36 At Week 36 all subjects will undergo liver biopsy
Detailed Description:
This is a multicenter randomized double-blind placebo-controlled study in subjects with a diagnosis of NASH and F1-3 fibrosis Subjects will undergo Screening procedures during the 6 weeks preceding Baseline Subjects n 114 will be randomly assigned in a 21 ratio to oral doses of namodenoson 25 mg every 12 hours or matching placebo every 12 hours for 36 weeks Subjects will be evaluated regularly for safety and efficacy biomarkers will be measured at Baseline and Weeks 6 12 24 and 36 At Week 36 all subjects will undergo post-treatment liver biopsy which will be interpreted by a blinded expert hepatopathologist Subjects will return for a follow-up visit 6 weeks after completion of the last dose of study drug
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None