Status:
RECRUITING
A Study to Document and to Further Describe Long-term Safety and Effectiveness of Palovarotene in Participants With Fibrodysplasia Ossificans Progressiva (FOP)
Lead Sponsor:
Ipsen
Conditions:
Fibrodysplasia Ossificans Progressiva
Eligibility:
All Genders
8+ years
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 bod...
Eligibility Criteria
Inclusion
- Inclusion Criteria :
- Adult or child with FOP who have been prescribed palovarotene (prior to and independently of the decision to enroll the patient in this registry study and as per local label) by their treating physician according to the locally approved product information;
- Signed informed consent as per local regulations must be obtained and maintained. Consent/assent from the participant should be obtained as appropriate before any registry study data collection are conducted. If applicable, parents or legally authorized representatives must give signed informed consent.
- Exclusion Criteria :
- Currently participating in a palovarotene clinical trial;
- Currently participating in any interventional clinical trial for FOP;
- Have any contraindication to palovarotene as per the locally approved label (except for pregnant women who have previously received and discontinued palovarotene at any time during the pregnancy and who will be included for safety follow-up).
Exclusion
Key Trial Info
Start Date :
December 5 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 5 2035
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06089616
Start Date
December 5 2024
End Date
December 5 2035
Last Update
December 31 2025
Active Locations (5)
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1
The Regents of the University of California
San Francisco, California, United States, 94103
2
The Trustees of the University of Pennsylvania, Office of Clinical Research-Legal Services, Perelman School of Medicine
Philadelphia, Pennsylvania, United States, 19104
3
Edmonton Clinic Health Academy (ECHA)- University of Alberta
Edmonton, Canada
4
Bone Research and Education Centre
Oakville, Canada