Condition: Fibrodysplasia Ossificans Progressiva · Sponsor: Ipsen
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 either be treated with palovarotene (i.e already be receiving palovarotene as prescribed by their treating physician according to locally approved product information) or untreated with palovarotene. The main aim of this registry study will be to collect and assess real-world safety data on children and adult participants with FOP treated with palovarotene. This registry study will also describe the effectiveness of palovarotene in exposed participants, including the effect on everyday activities and physical performance. In addition, this registry study aims to descriptively compare key safety outcomes (i.e. flare-up episodes, growth outcomes, and bone fractures) between participants exposed and unexposed to palovarotene.
This description comes directly from the study's public registry record.
Ipsen Clinical Study Enquiries · see email · clinical.trials@ipsen.com
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| The Regents of the University of California | San Francisco, California, United States | Recruiting |
| The Trustees of the University of Pennsylvania, Office of Clinical Research-Legal Services, Perelman School of Medicine | Philadelphia, Pennsylvania, United States | Recruiting |
| Edmonton Clinic Health Academy (ECHA)- University of Alberta | Edmonton, Canada | Recruiting |
| Bone Research and Education Centre | Oakville, Canada | Active Not Recruiting |
| University Health Network (UHN) - Toronto General | Toronto, Canada | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06089616