Documenting long-term safety and effectiveness of palovarotene in patients with fibrodysplasia ossificans progressiva

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational registry study aims to collect and assess real-world safety data on children and adults with fibrodysplasia ossificans progressiva (FOP) who are being treated with palovarotene. Participants will already be receiving palovarotene as prescribed by their treating physician, and the study will evaluate the treatment's effectiveness on everyday activities and physical performance. The study will take place in countries where palovarotene is approved for use, focusing on the long-term outcomes of this treatment in managing FOP.

Why it matters

Who can join: the full rules

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).

Where it's running

• 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
• University Health Network (UHN) - Toronto General
  Toronto, Canada Recruiting
• Bone Research and Education Centre
  Oakville, Canada Active not recruiting

Study contacts

• Study coordinator: Ipsen Clinical Study Enquiries
• Email: clinical.trials@ipsen.com
• Phone: see email

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Observing the effects of anti-IL1 therapies on flare activity in FOP patients

  This study is testing if using certain anti-inflammatory medications can help kids and teens with Fibrodysplasia Ossificans Progressiva manage their flare-ups and bone growth issues.

  Recruiting University of California, San Francisco · San Francisco, California · NCT06724562

• Evaluating INCB000928 for treating Fibrodysplasia Ossificans Progressiva

  This study is testing a new drug called INCB000928 to see if it can help people with Fibrodysplasia Ossificans Progressiva manage their symptoms better.

  Recruiting at 11 sites Phase 2 Incyte Corporation · Rochester, Minnesota and 23 other locations · NCT05090891

• Global registry for patients with Fibrodysplasia Ossificans Progressiva

  This study is creating a global registry to collect information from people with Fibrodysplasia Ossificans Progressiva and their caregivers to help improve understanding and treatment of the condition.

  Recruiting The International FOP Association · North Kansas City, Missouri · NCT02745158

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.