NCT05086575Active, not recruiting
Observatory of Patients With Haemophilia B Treated by IdElvion®
Source: ClinicalTrials.gov · Last updated 8 Jan 2025
Brief summary (registry, in English)
OrPHEe is a non-interventional, prospective and national study which aim is to record real life data in haemophilia B French patients treated with Idelvion® to confirm the efficacy and safety of this product established in clinical development studies.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 222 (actual)
- First submitted
- 28 Sept 2021
- Start date
- 3 Dec 2021
- Primary completion date
- Dec 2027
- Lead sponsor
- CSL Behring
- Diseases
- Haemophilia
- NCT number
- NCT05086575
What you commit to
- Study type: Observational
- Participants enrolled: 222
- From 3 Dec 2021 to the primary completion date, Dec 2027
- 28 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Simultaneous participation in an interventional clinical study on a drug
Other illness
- Existence of a contraindication to the use of Idelvion® treatment (known hypersensitivity to FIX or hamster proteins);
Other
- Refusal by the patient or his/her legal representative to participate in the study;
Who the study is looking for
- Have agreed to participate in the observatory after receiving written information on the purpose of the study and the personal data to be collected (agreement of parents for under-age patients);
- Present with haemophilia B and are currently being treated or have previously been treated with Idelvion® as a long-term prophylactic treatment, on-demand treatment or short-term treatment for surgical procedures or to cover periods with a high-risk of bleeding.
- Do not have FIX targeted antibodies at the time of the inclusion visit
Sex: All · Does not accept healthy volunteers
Sites (28)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Chu Amiens Picardie Coordinator of this site? Confirm its status | Amiens | France | Unknown status |
| Ch Annecy Genevois Coordinator of this site? Confirm its status | Annecy | France | Unknown status |
| Chru Besancon Coordinator of this site? Confirm its status | Besançon | France | Unknown status |
| CHU Bordeaux - Hopital Pellegrin Coordinator of this site? Confirm its status | Bordeaux | France | Unknown status |
| CHRU Brest Coordinator of this site? Confirm its status | Brest | France | Unknown status |
| CHU Caen Coordinator of this site? Confirm its status | Caen | France | Unknown status |
| CHU Clermont-Ferrand Coordinator of this site? Confirm its status | Clermont-Ferrand | France | Unknown status |
| CHU Dijon Coordinator of this site? Confirm its status | Dijon | France | Unknown status |
| Hôpital Simone Veil Coordinator of this site? Confirm its status | Eaubonne | France | Unknown status |
| CHU de Grenoble Coordinator of this site? Confirm its status | Grenoble | France | Unknown status |
| CRC-MHC Hôpital Kremlin Bicêtre Coordinator of this site? Confirm its status | Le Kremlin-Bicêtre | France | Unknown status |
| CH du Mans Coordinator of this site? Confirm its status | Le Mans | France | Unknown status |
| CHRU Lille Coordinator of this site? Confirm its status | Lille | France | Unknown status |
| CHU de Limoges Coordinator of this site? Confirm its status | Limoges | France | Unknown status |
| Hopital Edouard Herriot Coordinator of this site? Confirm its status | Lyon | France | Unknown status |
| CHU Montpellier Coordinator of this site? Confirm its status | Montpellier | France | Unknown status |
| CHRU Nancy Coordinator of this site? Confirm its status | Nancy | France | Unknown status |
| CHU Nantes Coordinator of this site? Confirm its status | Nantes | France | Unknown status |
| CHU Nice Coordinator of this site? Confirm its status | Nice | France | Unknown status |
| Hopital Necker Enfants Malades Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| CHU de Reims Coordinator of this site? Confirm its status | Reims | France | Unknown status |
| CHU Rennes Coordinator of this site? Confirm its status | Rennes | France | Unknown status |
| CHU Rouen Coordinator of this site? Confirm its status | Rouen | France | Unknown status |
| CHU Saint-Etienne Coordinator of this site? Confirm its status | Saint-Etienne | France | Unknown status |
| CHRU Strasbourg Coordinator of this site? Confirm its status | Strasbourg | France | Unknown status |
| CHU Toulouse Coordinator of this site? Confirm its status | Toulouse | France | Unknown status |
| CHU Tours Coordinator of this site? Confirm its status | Tours | France | Unknown status |
| Hôpital André Mignot (CH Versailles) Coordinator of this site? Confirm its status | Versailles | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.