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A Study to Document and to Further Describe Long-term Safety and Effectiveness of Palovarotene in Participants With Fibrodysplasia Ossificans Progressiva (FOP) — FOPal  

Fibrodysplasia Ossificans Progressiva Clinical Trial

Official title:
An International Observational Registry Study to Further Describe Long-term Safety and Effectiveness of Palovarotene in Patients With Fibrodysplasia Ossificans Progressiva (FOP)

Clinical Trial 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

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

  • Fibrodysplasia Ossificans Progressiva
Clinical Trial Details
NCT number NCT06089616
Study type Observational [Patient Registry]
Source Ipsen
Contact Ipsen Clinical Study Enquiries
Phone see email
Email clinical.trials@ipsen.com
Status Not yet recruiting
Phase
Start date April 15, 2024
Completion date January 31, 2034
View Details
See also
  Status Clinical Trial Phase
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Completed NCT02979769 - An Open-Label Extension Study of Palovarotene to Prevent Heterotopic Ossification in People With Fibrodysplasia Ossificans Progressiva (FOP) in France Phase 2
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Completed NCT04665323 - An International Cross-sectional Survey to Evaluate the Burden of Fibrodysplasia Ossificans Progressiva (FOP) on Patients and Their Families.
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Recruiting NCT05039515 - A Study to Assess the Effectiveness and Safety of 2 Dosage Regimens of Oral Fidrisertib (IPN60130) for the Treatment of Fibrodysplasia Ossificans Progressiva (FOP). Phase 2
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