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NCT05935358 · ClinicalTrials.gov registry record · Phase 4
Nuwiq for Perioperative Management Of Patients With Haemophilia A on Emicizumab Regular Prophylaxis Study
A Phase 4 study of Severe Hemophilia A, sponsored by Octapharma.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 28
- Enrollment target
- 18
- Study locations
NCT05935358: Recruiting Phase 4 study of Severe Hemophilia A, sponsored by Octapharma.
NCT05935358 is a Phase 4 study of Severe Hemophilia A that is actively recruiting participants, run by Octapharma. The registered enrollment target is 28 participants, below the 64-participant average among 4 other Severe Hemophilia A trials with a reported enrollment target (56% lower). The trial reports 18 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05935358, a Phase 4 study of Severe Hemophilia A, is actively recruiting participants, sponsored by Octapharma.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 28 participants
- Enrollment target
- 18
- Study locations
Study Summary
Recombinant factor VIII for the prevention of bleeding in patients with severe haemophilia A undergoing major surgery while receiving emicizumab prophylaxis
Primary Outcome
Overall haemostatic efficacy of treatment measured as binary "success" or "failure". The overall perioperative haemostatic efficacy of Nuwiq will be adjudicated by an Independent Data Monitoring Committee (IDMC) and determined using a composite assessment algorithm that considers the surgeon's assessment of intraoperative haemostatic efficacy and the investigator's assessment of postoperative haemostatic efficacy to classify the overall haemostatic efficacy as success or failure.
Conditions Studied
Interventions
- DRUG Nuwiq
Study Locations (18)
Other
- University Hospital Centre Zagreb - Zagreb
- Helsinki University Hospital - Helsinki
- CHU de Nantes Hôtel-Dieu - Nantes
- CHRU de Tours - Tours
- Vivantes Klinikum im Friedrichshein (KFH) - Berlin
- Gerinnungszentrum Rhein-Ruhr - Duisburg
- Universitätsklinikum Hamburg Eppendorf (UKE) - Hamburg
- St. John's Medical College Hospital - Bengaluru
- Azienda Ospedaliera Pugliese Ciaccio - Catanzaro
- Azienda Ospedaliero Universitaria Careggi - Centro Emofilia - Florence
- Centro Trombosi e Malattie Emorragiche, ITCCS Humanitas Research Hospital - Milan
- Centre for Haemopilia, Institute for transfusion medicine of Republic of North Macedonia - Skopje
- Clinical Center for Serbia Belgrade - Belgrade
- Hospital Universitario La Paz - Madrid
- Hospital Universitario Virgen del Rocio - Seville
- St. James's University Hospital - Leeds
Texas
- UT Southwestern Medical Center - Dallas
Tamil Nadu
- Christian Medical College Vellore - Vellore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2023-11-28 |
| Est. Completion | 2026-08 |
| Phase | Phase 4 |
What NCT05935358 shows while recruiting
NCT05935358 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 64-participant average among 4 other Severe Hemophilia A trials with a reported enrollment target (56% lower).
The record links to 1 condition, with Severe Hemophilia A appearing as the primary indexed condition, and to 1 intervention - of which Nuwiq is the first listed.
NCT05935358 lists 18 locations in 3 states (Other, Texas, Tamil Nadu).
Frequently Asked Questions
What is clinical trial NCT05935358 about?
NCT05935358 is a clinical study titled "Nuwiq for Perioperative Management Of Patients With Haemophilia A on Emicizumab Regular Prophylaxis Study". Recombinant factor VIII for the prevention of bleeding in patients with severe haemophilia A undergoing major surgery while receiving emicizumab prophylaxis
What is the current status of trial NCT05935358?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 28 participants. The study started on 2023-11-28. Estimated completion is 2026-08.
What conditions does trial NCT05935358 study?
This clinical trial studies the following conditions: Severe Hemophilia A.
What interventions are being tested in trial NCT05935358?
The interventions under investigation include: Nuwiq (DRUG).
Who is sponsoring clinical trial NCT05935358?
This trial is sponsored by Octapharma, which has 43 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05935358 being conducted?
This trial has 18 study locations across Texas, Tamil Nadu. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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