NCT02994147

A Proof-of-Concept Study of AC-201 Controlled-Release Tablet (CR Tablet) in Patients With Hemophilic Arthropathy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: TWi Biotechnology, Inc. · Industry
• Sex: Male
• Age: 20 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hemophilic Arthropathy

Interventions

Type	Name	Description
DRUG	Placebo	Placebo-only control study medication is the same formulation as active treatment without active ingredient
DRUG	AC-201CR	The investigational product is formulated as controlled-release (CR) tablets

Timeline

• Start date: 2017-03-21
• Primary completion: 2019-04-18
• Completion: 2019-10-02
• First posted: 2016-12-15
• Last updated: 2020-07-09

Locations

1 site across 1 country: Taiwan