Viewing Study NCT06089616



Ignite Creation Date: 2024-05-06 @ 7:38 PM
Last Modification Date: 2024-10-26 @ 3:11 PM
Study NCT ID: NCT06089616
Status: NOT_YET_RECRUITING
Last Update Posted: 2024-07-12
First Post: 2023-10-06

Brief Title: A Study to Document and to Further Describe Long-term Safety and Effectiveness of Palovarotene in Participants With Fibrodysplasia Ossificans Progressiva FOP
Sponsor: Ipsen
Organization: Ipsen

Study Overview

Official Title: An International Observational Registry Study to Further Describe Long-term Safety and Effectiveness of Palovarotene in Patients With Fibrodysplasia Ossificans Progressiva FOP
Status: NOT_YET_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: FOPal
Brief Summary: The participants in this registry study will have fibrodysplasia ossificans progressiva FOP

FOP is an ultra-rare severely disabling disease characterized by new bone formation in areas of the body where bone is not normally present heterotopic ossification HO

HO is often preceded by painful recurrent episodes of soft tissue swelling flare-ups

This registry study will take place in countries where the treatment known as palovarotene has been approved for use Participants will already be receiving palovarotene as prescribed by their treating physician according to locally approved product information

The main aim of this study will be to collect and assess real-world safety data on children and adult participants with FOP treated with palovarotene

This study will also describe the effectiveness of this treatment including the effect on everyday activities and physical performance
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