Ignite Creation Date:
2024-05-06 @ 9:29 AM
Last Modification Date:
2024-10-26 @ 12:15 PM
Study NCT ID:
NCT02994147
Status:
COMPLETED
Last Update Posted:
2020-07-09
First Post:
2016-12-09
Brief Title:
A Proof-of-Concept Study of AC-201 Controlled-Release Tablet CR Tablet in Patients With Hemophilic Arthropathy
Sponsor:
TWi Biotechnology Inc
Organization:
TWi Biotechnology Inc
Study Overview
Official Title:
A Proof-of-Concept Study of AC-201 Controlled-Release Tablet CR Tablet in Patients With Hemophilic Arthropathy
Status:
COMPLETED
Status Verified Date:
2020-07
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:
Repeated joint bleeding leads to hemophilic arthropathy HA which manifests with chronic synovitis cartilage damage and bony destruction Currently available treatments of HA including analgesics NSAIDs and hyaluronic acid are predominantly directed toward the symptomatic relief of pain and inflammation with no or little effect on joint cartilage degeneration AC201CR a control released formulation of AC-201 demonstrates anti-inflammatory effects by reducing NLRP3 inflammasome assembly AC-201 is also unique in that it influences both the anabolism and catabolism of chondrocytes in vitro and has shown cartilage-sparing properties in animal studies The study is designed to evaluate the joint structure-modifying and symptom-relieving effects safety and tolerability of AC-201CR in subjects with HA
Detailed Description:
None
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?:
None
Is an FDA AA801 Violation?:
None