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rFVIIa

DRUG5 trials

Sponsors

Fondazione IRCCS Policlinico San Matteo di Pavia, Centre Hospitalier Universitaire de Nīmes, Dr. David Gladstone, Hoffmann-La Roche, Emory University

Conditions

Hemophilia AIntracerebral HemorrhagePostpartum HemorrhageStroke

Phase 2

Efficacy and Safety of Factor VIIa on Rebleeding After Surgery for Spontaneous Intracerebral Hemorrhage (ICH)
CompletedNCT00128050
Fondazione IRCCS Policlinico San Matteo di PaviaIntracerebral Hemorrhage
Start: 2005-01-31End: 2008-12-31Updated: 2009-02-04
Spot Sign Selection of Intracerebral Hemorrhage to Guide Hemostatic Therapy
CompletedNCT01359202
Dr. David GladstoneStroke
Start: 2011-05-31End: 2018-10-03Updated: 2018-10-05

Phase 3

A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Prophylactic Emicizumab Versus no Prophylaxis in Hemophilia A Participants With Inhibitors
CompletedNCT02622321
Hoffmann-La RocheHemophilia A
Start: 2015-11-18End: 2020-12-01Updated: 2021-06-24
SAFE Study: Safety of aPCC Following Emicizumab Prophylaxis
RecruitingNCT04563520
Emory UniversityHemophilia A
Start: 2026-09-01End: 2027-03-01Target: 5Updated: 2026-08-21

Phase 4

rhuFVIIa in Post-partum Hemorrhage
CompletedNCT00370877
Centre Hospitalier Universitaire de NīmesPostpartum Hemorrhage
Start: 2007-04-30End: 2010-11-30Updated: 2015-03-27

Related Papers

Exploratory analysis from HAVEN 1–4 to further contextualize injection-site reactions among people with hemophilia A receiving emicizumab
Blood2025-11-03
Pain‐Related Quality of Life Outcomes in People With Haemophilia A Receiving Emicizumab: A Post Hoc Analysis of the HAVEN 1, 3 and 4 and STASEY Studies
Haemophilia2024-12-182 citations
Efficacy and Safety Analyses of Recombinant Factor VIIa in Severe Post-Partum Hemorrhage
Journal of Clinical Medicine2024-05-013 citations
Emicizumab is efficacious in people with hemophilia A with comorbidities aged ≥50 years: analysis of 4 phase III trials.
2024-03-012 citations
Clinical Features, Non-Contrast CT Radiomic and Radiological Signs in Models for the Prediction of Hematoma Expansion in Intracerebral Hemorrhage
Canadian Association of Radiologists Journal2023-04-183 citations
Time Course of Early Hematoma Expansion in Acute Spot-Sign Positive Intracerebral Hemorrhage: Prespecified Analysis of the SPOTLIGHT Randomized Clinical Trial
Stroke2023-02-0915 citations
Surgical outcomes in people with hemophilia A taking emicizumab prophylaxis: experience from the HAVEN 1-4 studies
Blood Advances2022-08-0841 citations
Emicizumab Prophylaxis in Persons with Hemophilia A, Aged ≥50 Years, with Comorbidities - Pooled Data from Four Phase III Studies (HAVEN 1, 3, and 4, and STASEY)
Blood2021-11-05
Long-term outcomes with emicizumab prophylaxis for hemophilia A with or without FVIII inhibitors from the HAVEN 1-4 studies
Blood2020-12-19270 citations
Safety and Efficacy of Emicizumab in Persons with Hemophilia a with or without FVIII Inhibitors: Pooled Data from Four Phase III Studies (HAVEN 1-4)
Blood2020-11-044 citations
Pharmacokinetics and Pharmacodynamics of Emicizumab in Persons with Hemophilia A with Factor VIII Inhibitors: HAVEN 1 Study
Thrombosis and Haemostasis2020-10-2190 citations
Effect of Recombinant Activated Coagulation Factor VII on Hemorrhage Expansion Among Patients With Spot Sign–Positive Acute Intracerebral Hemorrhage
JAMA Neurology2019-08-19113 citations
Health‐related quality of life and health status in persons with haemophilia A with inhibitors: A prospective, multicentre, non‐interventional study (NIS)
Haemophilia2019-04-2446 citations
Immunogenicity of Emicizumab in People with Hemophilia A (PwHA): Results from the HAVEN 1-4 Studies
Blood2018-11-2958 citations
The effect of emicizumab prophylaxis on health‐related outcomes in persons with haemophilia A with inhibitors: HAVEN 1 Study
Haemophilia2018-11-1491 citations
Emicizumab Prophylaxis in Hemophilia A with Inhibitors
New England Journal of Medicine2017-07-101030 citations
Bleeding Events and Safety Outcomes in Patients with Hemophilia a with Inhibitors: A Prospective, Multicenter, Non-Interventional Study
Blood2016-12-022 citations
Synergistic Effects of a Procoagulant Bispecific Antibody and Rescue Therapies on Thrombin Generation- a Potential Safety Risk
Blood2016-12-021 citations