Ignite Creation Date:
2024-07-17 @ 11:16 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06463132
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-17
First Post:
2024-06-07
Brief Title:
Phase 1b Clinical Trial to Evaluate PEP and EUFLEXXA for Knee Osteoarthritis KOA
Sponsor:
Rion Inc
Organization:
Rion Inc
Study Overview
Official Title:
Phase 1b Open-Label Multi-Center Randomized Trial to Evaluate the Safety of PEP and EUFLEXXA for the Treatment of Subjects With Knee Osteoarthritis KOA
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
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:
Evaluate the safety and exploratory efficacy of single intra-articular injections of PEP reconstituted with 09 Normal Saline at a low dose one vial PEP and high dose two vials PEP with and without EUFLEXXA for the treatment of Knee Osteoarthritis
Detailed Description:
Study Plan with Dose Escalation Arm 1 and Arm 2 will run in parallel such that initially 3 subjects will be enrolled in Arm 1a PEP Low Dose and 3 subjects will be enrolled in Arm 2a PEP-EUFLEXXA Low Dose After all 6 subjects complete the 30 day follow up and there was not more than 1 AE grade 3 or higher per Arm a further 9 subjects will be enrolled in Arm 1b PEP High Dose and a further 9 subjects will be enrolled in Arm 2b PEP-EUFLEXXA High Dose
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None