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NCT06089616 · ClinicalTrials.gov registry record
A Study to Document and to Further Describe Long-term Safety and Effectiveness of Palovarotene in Participants With Fibrodysplasia Ossificans Progressiva (FOP)
A clinical trial of Fibrodysplasia Ossificans Progressiva, sponsored by Ipsen.
- Recruiting
- Registry status
- 100
- Enrollment target
- 5
- Study locations
NCT06089616: Recruiting study of Fibrodysplasia Ossificans Progressiva, sponsored by Ipsen.
NCT06089616 is a study of Fibrodysplasia Ossificans Progressiva that is actively recruiting participants, run by Ipsen. The registered enrollment target is 100 participants, above the 79-participant average among 4 other Fibrodysplasia Ossificans Progressiva trials with a reported enrollment target (27% higher). The trial reports 5 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06089616, a study of Fibrodysplasia Ossificans Progressiva, is actively recruiting participants, sponsored by Ipsen.
- RECRUITING
- Registry status
- 100 participants
- Enrollment target
- 5
- Study locations
Study 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 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.
Primary Outcome
Adverse events will be coded according to MedDRA and will be classified by Preferred Term (PT) and system organ class (SOC).
Conditions Studied
Study Locations (5)
Other
- Edmonton Clinic Health Academy (ECHA)- University of Alberta - Edmonton
- Bone Research and Education Centre - Oakville
- University Health Network (UHN) - Toronto General - Toronto
California
- The Regents of the University of California - San Francisco
Pennsylvania
- The Trustees of the University of Pennsylvania, Office of Clinical Research-Legal Services, Perelman School of Medicine - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2024-12-05 |
| Est. Completion | 2035-12-05 |
What NCT06089616 shows while recruiting
NCT06089616 is an observational study that tracks outcomes without assigning an intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, above the 79-participant average among 4 other Fibrodysplasia Ossificans Progressiva trials with a reported enrollment target (27% higher).
The record links to 1 condition, with Fibrodysplasia Ossificans Progressiva appearing as the primary indexed condition, and to 0 interventions.
NCT06089616 lists 5 locations in 3 states (Other, California, Pennsylvania).
Frequently Asked Questions
What is clinical trial NCT06089616 about?
NCT06089616 is a clinical study titled "A Study to Document and to Further Describe Long-term Safety and Effectiveness of Palovarotene in Participants With Fibrodysplasia Ossificans Progressiva (FOP)". 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 painf...
What is the current status of trial NCT06089616?
This trial is currently recruiting. The enrollment target is 100 participants. The study started on 2024-12-05. Estimated completion is 2035-12-05.
What conditions does trial NCT06089616 study?
This clinical trial studies the following conditions: Fibrodysplasia Ossificans Progressiva.
Who is sponsoring clinical trial NCT06089616?
This trial is sponsored by Ipsen, which has 85 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06089616 being conducted?
This trial has 5 study locations across California, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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