Clinical trials: Haemophilia A With Inhibitors
Hemophilia A With Inhibitors, Hemophilia B With Inhibitors
Study of Recombinant Factor VIIa Fusion Protein (rVIIa-FP, CSL689) for On-demand Treatment of Bleeding Episodes in Patients With Hemophilia A or B With Inhibitors
The purpose of this study is to investigate the pharmacokinetics (PK), efficacy, and safety of rVIIa-FP (CSL689). The study will enroll approximately 54 male subjects, 12 to 65 years of age, with hemophilia types A or B who have…
- Trial name
- NCT02484638
- Testing
- CSL689, Eptacog alfa (activated)
- Where
- 10 sites in Georgia, Italy and 7 more
- Volunteers
- 25 people
- Sponsor
- CSL Behring
Congenital Bleeding Disorder, Haemophilia A With Inhibitors
A Long-term Assessment of Physical Activity, Range of Motion, and Functional Status Following Elective Orthopedic Surgery in Hemophilia Patients With Inhibitors
This study is conducted in the United States of America (USA). The aim of this study is to assess the long-term (5+ years) postoperative functional outcomes of elective orthopaedic surgery (EOS) patients from previously reported…
- Conditions
- Congenital Bleeding Disorder, Haemophilia A With Inhibitors, Haemophilia B With Inhibitors
- Trial name
- NCT01830712
- Testing
- eptacog alfa (activated)
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- Novo Nordisk A/S
Hemophilia A
A Study of Emicizumab Administered Subcutaneously (SC) in Pediatric Participants With Hemophilia A and Factor VIII (FVIII) Inhibitors
This non-randomized, multicenter, open-label, Phase III clinical study will evaluate the efficacy, safety, and pharmacokinetics of emicizumab administered subcutaneously initially once weekly (QW) in pediatric participants with…
- Trial name
- HAVEN 2 (NCT02795767)
- Testing
- Emicizumab
- Where
- 28 sites in United States, Costa Rica and 8 more
- Volunteers
- 88 people
- Sponsor
- Hoffmann-La Roche
Congenital Bleeding Disorder, Haemophilia A
Post-marketing Safety Surveillance of NovoSeven® in Patients With Haemophilia and Inhibitors by Means of the UK Haemophilia Database
This study is conducted in Europe. The purpose of this retrospective study is to collect additional safety information of patients with haemophilia and inhibitors who are treated with rFVIIa.
- Conditions
- Congenital Bleeding Disorder, Haemophilia A, Haemophilia B
- Trial name
- NCT00853086
- Testing
- activated recombinant human factor VII
- Where
- United Kingdom
- Volunteers
- 139 people
- Sponsor
- Novo Nordisk A/S
Hemophilia
Global Haemostatic Methods Following Administration of Bypassing Agents to Patients With Haemophilia With Inhibitors
Background The treatment of haemophilia A and B has been revolutionized by the use of factor concentrate, both as prophylaxis and to treat bleeding episodes (on-demand treatment).
- Trial name
- NCT02453542
- Where
- Sweden
- Volunteers
- 20 people
- Sponsor
- Karolinska Institutet
Hemophilia A With Inhibitor
An Exploration of the Impact of Emicizumab on the Lives of People With Haemophilia and Inhibitors and Their Families
This study aims to examine the real-life experience and impact of using emicizumab in a cohort of patients with haemophilia and inhibitors, who were prescribed emicizumab as part of the early access to medicine schema…
- Trial name
- EmiandMe (NCT04723693)
- Testing
- Qualitative Interview
- Where
- United Kingdom
- Volunteers
- 30 people
- Sponsor
- Haemnet
Haemophilia A, Haemophilia B
Post-marketing Surveillance (Special Use-results Surveillance) on Treatment With Alhemo
The purpose of the study is to investigate the safety and effectiveness of Alhemo in participants under real-world clinical practice in Japan. Total duration of this study is about 6 years.
- Trial name
- NCT06831734
- Testing
- Concizumab
- Where
- 23 sites in Japan
- Volunteers
- 30 people
- Sponsor
- Novo Nordisk A/S
Hemophilia A
SAFE Study: Safety of aPCC Following Emicizumab Prophylaxis
The purpose of the aPCC-emicizumab safety study is to investigate the hemostatic efficacy as measured by thrombin generation, of a low personalized dose of aPCC (FEIBA) in children and adults with hemophilia A and inhibitors on…
- Trial name
- SAFE (NCT04563520)
- Testing
- Emicizumab, FEIBA, rFVIIa
- Where
- 2 sites in United States
- Volunteers
- 5 people
- Sponsor
- Emory University
Severe Hemophilia A With an Inhibitor
The FEIBA NovoSeven Comparative Study
FENOC is a prospective, open-label, randomized, cross-over, multi-center study to investigate and compare the hemostatic effect and cost-efficacy of two different by-passing agents in the treatment of joint hemorrhages in…
- Trial name
- NCT00166309
- Testing
- FEIBA and NovoSeven
- Where
- Sweden
- Volunteers
- 60 people
- Sponsor
- Skane University Hospital
Hemophilia A
Early Prophylaxis Immunologic Challenge (EPIC) Study
The purpose of the study was to assess if a once-weekly prophylactic regimen of 25 IU/kg ADVATE started at or before 1 year of age and before the onset of a severe bleeding phenotype (ie, joint bleeding), together with the…
- Trial name
- EPIC (NCT01376700)
- Testing
- Recombinant antihemophilic factor, plasma/albumin-free method (rAHF-PFM)
- Where
- 19 sites in United States, Austria and 10 more
- Volunteers
- 22 people
- Sponsor
- Baxalta now part of Shire
Severe Hemophilia A
Rescue Immunotolerance Study in Induction of Immune Tolerance (ITI)-Experienced Patients (RES.I.S.T. Experienced)
The purpose of this study is to evaluate whether a concentrate containing both FVIII and von Willebrand Factor (VWF) given at a high dose will induce immune tolerance in subjects who have already experienced and failed ITI with…
- Trial name
- RESIST EXP (NCT01051076)
- Testing
- VWF/FVIII concentrates
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- City of Hope Medical Center
Haemophilia A, Haemophilia A With Inhibitors
A Study Following People With Haemophilia A and B, With or Without Inhibitors, When on Usual Treatment (Explorer™6)
This study will collect data on bleeds and data related to quality of life in people with severe congenital (a disease existing from birth) haemophilia A and B, with or without inhibitors.
- Conditions
- Haemophilia A, Haemophilia A With Inhibitors, Haemophilia B, Haemophilia B With Inhibitors
- Trial name
- explorer™6 (NCT03741881)
- Testing
- No treatment given
- Where
- 143 sites in United States, Algeria and 34 more
- Volunteers
- 231 people
- Sponsor
- Novo Nordisk A/S
Haemophilia A, Haemophilia B
Post-Marketing Surveillance (All Case Surveillance) on Treatment With Alhemo® in Patients With Haemophilia A or Haemophilia B With Inhibitors
The purpose of the study is to investigate the safety and effectiveness of Alhemo® in all participants under real-world clinical practice in Japan. Participants will get Alhemo® as prescribed by the study doctor.
- Trial name
- NCT06285071
- Testing
- Concizumab
- Where
- 11 sites in Japan
- Volunteers
- 23 people
- Sponsor
- Novo Nordisk A/S
Hemophilia B with Inhibitor, Hemophilia B
A Study of SerpinPC in Participants with Hemophilia B (HemB) with Inhibitors
The purpose of the study is to evaluate the efficacy, safety, tolerability and pharmacokinetic (PK) profile of prophylactic SerpinPC in participants with Hemophilia B with inhibitors, as part of the SerpinPC registrational…
- Trial name
- PRESent-3 (NCT05789537)
- Testing
- SerpinPC
- Where
- 20 sites in United States, Armenia and 9 more
- Volunteers
- 3 people
- Sponsor
- ApcinteX Ltd
Hemophilia A With Inhibitor
rFVIIIFc (Elocta®) ITI Chart Review in Patients With Haemophilia A
A chart review study of patients with haemophilia A with inhibitors treated with rFVIIIFc (Elocta®) for immune tolerance induction.
- Trial name
- NCT03951103
- Testing
- rFVIIIFc
- Where
- 18 sites in France, Germany and 6 more
- Volunteers
- 44 people
- Sponsor
- Swedish Orphan Biovitrum
Congenital Bleeding Disorder, Haemophilia A
Investigating the Bioequivalence of Eptacog Alfa A 6 mg and NovoSeven® in Healthy Male Subjects
This trial is conducted in Europe. The aim of the trial is to investigate the bioequivalence of eptacog alfa A 6 mg and NovoSeven® in healthy male subjects.
- Conditions
- Congenital Bleeding Disorder, Haemophilia A, Haemophilia A With Inhibitors, Haemophilia B
- Trial name
- NCT02084810
- Testing
- activated recombinant human factor VII, eptacog alfa (activated)
- Volunteers
- healthy volunteers welcome
- Sponsor
- Novo Nordisk A/S
Hemophilia A
Safety/Efficacy Study to Assess Whether FVIII/VWF Concentrate Can Induce Immune Tolerance in Haemophilia A Patients
The purpose of this study is to assess the role of a FVIII/VWF complex concentrate (Emoclot) in successfully inducing immune tolerance (I.T.I.) in patients with Haemophilia A with inhibitors, including patients at high risk of…
- Trial name
- ITI (NCT02479087)
- Testing
- Plasma-derived FVIII/VWF concentrate
- Where
- 4 sites in Egypt, India
- Volunteers
- 20 people
- Sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Hemophilia A, Hemophilia B
A Study of Fitusiran (ALN-AT3SC) in Severe Hemophilia A and B Patients Without Inhibitors
Primary Objective: -To evaluate the efficacy of fitusiran compared to on-demand treatment with factor concentrates, as determined by the frequency of bleeding episodes.
- Trial name
- NCT03417245
- Testing
- fitusiran, factor concentrates
- Where
- 64 sites in United States, Australia and 17 more
- Volunteers
- 120 people
- Sponsor
- Genzyme, a Sanofi Company
Hemophilia
MOTHIF II : THERAPEUTIC MANAGEMENT AND USE OF CLOTTING FACTORS IN HEMOPHILIA A & B IN FRANCE II
MOTHIF II is a non-interventional, multicenter, retrospective, observational data collection in seven French Haemophilia Treatment Centers of the BERHLINGO network.
- Trial name
- MOTHIF II (NCT03596814)
- Testing
- No Interventional study
- Where
- 7 sites in France
- Volunteers
- 2,072 people
- Sponsor
- Nantes University Hospital
Hemophilia A Without Inhibitor, Hemophilia B Without Inhibitor
Efficacy and Safety of KN057 Prophylaxis in Patients With Haemophilia A or B Without Inhibitors
The purpose of this study is to show that KN057 can prevent bleeds in patients with haemophilia A or B without inhibitors and is safe to use.
- Trial name
- NCT06569108
- Testing
- KN057
- Where
- China
- Volunteers
- 125 people
- Sponsor
- Suzhou Alphamab Co., Ltd.