Clinical trials: Coagulation Protein Disorders
Hemophilia, Inhibitors
PCC Treatment for Hemophilia Patients With Inhibitor（2022PCC-A）
This study is a multicenter, prospective, single-arm exploratory clinical trial designed to evaluate the efficacy and safety of prothrombin complex concentrate (PCC) in the treatment of bleeding episodes in patients with…
- Trial name
- 2022PCC-A (NCT07406139)
- Testing
- PCC
- Where
- China
- Volunteers
- 30 people
- Sponsor
- Institute of Hematology & Blood Diseases Hospital, China
Severe Haemophilia
Quality of Life and Adjustment Among Siblings of Children and Adolescents With Severe Hemophilia
Severe hemophilia is a rare and chronic disease characterized by spontaneous bleedings from early childhood, which may lead to various complications especially in joints.
- Trial name
- FRATHEMO (NCT03299699)
- Where
- France
- Volunteers
- 30 people
- Sponsor
- Assistance Publique Hopitaux De Marseille
Hemophilia A With Inhibitor, Haemophilia A Without Inhibitor
ATHN 7: Hemophilia Natural History Study
This is a real-world study of the safety of the treatments used for people with hemophilia. The study will follow people with hemophilia A or B from across the country for about 4 years as they receive treatment.
- Conditions
- Hemophilia A With Inhibitor, Haemophilia A Without Inhibitor, Hemophilia B With Inhibitor, Haemophilia B Without Inhibitor
- Trial name
- ATHN 7 (NCT03619863)
- Where
- 29 sites in United States
- Volunteers
- 395 people
- Sponsor
- American Thrombosis and Hemostasis Network
Hemophilia A
BAX 855 Dose-Escalation Safety Study
The objectives of this study are to assess the tolerability and safety after single dose treatments of BAX 855 in previously treated patients (PTPs) with severe hemophilia A, to determine the pharmacokinetic (PK) parameters of…
- Trial name
- NCT01599819
- Testing
- Antihemophilic Factor (Recombinant) - Plasma/Albumin Free Method, PEGylated Recombinant Factor VIII
- Where
- 8 sites in Bulgaria, Germany and 2 more
- Volunteers
- 19 people
- Sponsor
- Baxalta now part of Shire
Hemophilia, Embolization
Embolization in Hereditary Coagulopathies
This is a longitudinal, prospective study, which will include 30 subjects with hereditary coagulopathies, with arthropathy, chronic synovitis resulting from hemarthrosis of the elbows, knees and/or ankles followed up at the…
- Conditions
- Hemophilia, Embolization, Hemarthrosis, Clotting Factor Deficiency
- Trial name
- EHCO (NCT05629130)
- Testing
- embolization with spherical microparticles embosphere
- Where
- Brazil
- Volunteers
- 30 people
- Sponsor
- University of Sao Paulo General Hospital
Haemophilia A
Post-Marketing Safety Study Following Long-Term Prophylactic OptivateTreatment in Subjects With Severe Haemophilia A
Primary objective: To assess post-marketing immunogenicity of Optivate® by monitoring plasma inhibitor levels for at least 100 Exposure Days (EDs) for each subject.
- Trial name
- NCT01811875
- Testing
- Optivate 500IU
- Where
- 4 sites in Colombia, Germany and 1 more
- Volunteers
- 7 people
- Sponsor
- Bio Products Laboratory
Hemophilia
A Proof-of-concept Study to Reduce Treatment Burden in Haemophilia Participants Receiving Factor VIII and Factor IX Infusions
The main aim is to describe how the treatment burden and challenges of participants, relatives, and doctors during regular Factor VIII and Factor IX infusions to treat hemophilia evolve using a virtual-reality (VR) based…
- Trial name
- NCT05437211
- Testing
- Virtual-reality (VR) Based Solution
- Where
- 6 sites in France
- Volunteers
- 24 people
- Sponsor
- Takeda
Hemophilia B, Mucopolysaccharidosis I
Long Term Follow-up (LTFU) of Subjects Who Received SB-318, SB-913, or SB-FIX
Long-term follow-up of subjects who received SB-318, SB-913, or SB-FIX in a previous trial and completed at least 52 weeks post-infusion follow-up in their primary protocol.
- Conditions
- Hemophilia B, Mucopolysaccharidosis I, Mucopolysaccharidosis II
- Trial name
- LTFU (NCT04628871)
- Testing
- SB-318, SB-913, SB-FIX
- Where
- 5 sites in United States
- Volunteers
- 13 people
- Sponsor
- Sangamo Therapeutics
Hemophilia A
A Gene Transfer Study for Hemophilia A
This clinical research study is being conducted by Spark Therapeutics, Inc. to determine the safety and efficacy of the factor VIII gene transfer treatment with SPK-8011 in individuals with hemophilia A.
- Trial name
- NCT03003533
- Testing
- SPK-8011
- Where
- 16 sites in United States, Australia and 3 more
- Volunteers
- 25 people
- Sponsor
- Spark Therapeutics, Inc.
Hemophilia
Predictors of Physical Activity in Adult Patients With Hemophilic Arthropathy
Introduction. The development of hemophilic arthropathy causes degenerative joint damage that leads to functional impairment, limiting physical activity and causing disability in patients with hemophilia. Objectives.
- Trial name
- NCT06960499
- Testing
- Surveys
- Where
- Spain
- Volunteers
- 88 people, healthy volunteers welcome
- Sponsor
- Universidad Católica San Antonio de Murcia
Hemophilia A
A Study to Evaluate the Safety and Tolerability of Prophylactic Emicizumab in Hemophilia A Patients With Inhibitors
This is a phase IIIb, single arm, open-label, multi-center study to evaluate the safety and tolerability of emicizumab in participants with congenital hemophilia A who have documented inhibitors against Factor VIII (FVIII) at…
- Trial name
- STASEY (NCT03191799)
- Testing
- Emicizumab
- Where
- 72 sites in Australia, Belgium and 22 more
- Volunteers
- 195 people
- Sponsor
- Hoffmann-La Roche
Hemophilia A or B
A Study to Describe Patient REal-world FitusiRan ExpeRience
This is a real-world, mixed-methods observational study conducted among adolescent (ages 12-17 years) and adult participants diagnosed with hemophilia A or B, with or without Factor VIII (FVIII) or Factor IX (FIX) inhibitors, who…
- Trial name
- PREFER (NCT07895381)
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Sanofi
Haemophilia B
An Open Study to Investigate the Safety and Efficacy of Replenine®-VF in Severe Haemophilia B Patients
To compare the first and second recovery assessments on Replenine®-VF and to evaluate recovery of different batches if patients changed batches during the study.
- Trial name
- NCT02231944
- Testing
- Replenine®-VF (High Purity Factor IX)
- Where
- 7 sites in Poland, United Kingdom
- Sponsor
- Bio Products Laboratory
Invasive PreNatal Diagnosis in a Context of Family History of Single-gene Disorders, Including, Sickle Cell Disease
Development of Non-Invasive Prenatal Diagnosis for Single Gene Disorders
Cell-free fetal DNA (cffDNA) is present in the maternal blood from the early first trimester of gestation and makes up 5%-20% of the total circulating cell-free DNA (cfDNA) in maternal plasma.
- Conditions
- Invasive PreNatal Diagnosis in a Context of Family History of Single-gene Disorders, Including, Sickle Cell Disease, Cystic Fibrosis, Fragile X Syndrome
- Trial name
- DANNIgene (NCT06147414)
- Testing
- Blood sample
- Where
- France
- Volunteers
- 550 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Adult Acute Lymphoblastic Leukemia in Remission, Adult Acute Myeloid Leukemia in Remission
A Two-Step Approach to Reduced Intensity Bone Marrow Transplant for Patients With Hematological Malignancies
This phase II trial studies how well reduced intensity donor stem cell transplant works in treating patients with hematologic malignancies.
- Conditions
- Adult Acute Lymphoblastic Leukemia in Remission, Adult Acute Myeloid Leukemia in Remission, Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities, Adult Acute Myeloid Leukemia With Del(5q)
- Trial name
- NCT01384513
- Testing
- Fludarabine, Busulfan, Total Body Irradiation (TBI)
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
Congenital Bleeding Disorder, Haemophilia A
Investigation of the Pharmacokinetics of Turoctocog Alfa in Subjects With Haemophilia A
This trial is conducted in Europe. The aim of the trial is to investigate the pharmacokinetics (the exposure of the trial drug in the body) of four lots of turoctocog alfa (a human recombinant coagulation factor VIII (FVIII)) in…
- Trial name
- NCT01692925
- Testing
- turoctocog alfa
- Where
- 5 sites in Germany, Latvia and 2 more
- Volunteers
- 15 people
- Sponsor
- Novo Nordisk A/S
Hemophilia C
A Single and Low Dose of Recombinant Factor VIIa in Patients With Severe Factor XI Deficiency Undergoing Surgery
Lately the investigators found that patients with severe factor XI deficiency and inhibitors could undergo major surgery with a single low dose of recombinant factor VIIa and tranexamic agent.
- Trial name
- rFVIIa (NCT01538160)
- Testing
- recombinant factor VIIa
- Where
- 3 sites in Israel
- Volunteers
- 15 people
- Sponsor
- Sheba Medical Center
Hemophilia
Movement Visualization in Patients With Hemophilic Arthropathy
Background. The recurrence of hemarthrosis in patients with hemophilia favors the development of an intra-articular, degenerative and progressive lesion (hemophilic arthropathy).
- Trial name
- NCT04237766
- Testing
- Experimental group
- Volunteers
- 140 people, healthy volunteers welcome
- Sponsor
- Real Fundación Victoria Eugenia
Preterm Birth, Coagulation Protein Disorders
Stratifying Risk for Intracerebral Haemorrhage
This study aims to investigates the role of gestational age on the prevalence of coagulation factors and components of the complement system in preterm- (≤32+0 weeks) and term neonates (≥37+0 weeks) and their role for the…
- Conditions
- Preterm Birth, Coagulation Protein Disorders, Coagulation Disorder Neonatal
- Trial name
- NEW_STRATEGI (NCT04140812)
- Testing
- mass spectrometry (LC-MS/MS)
- Where
- Germany
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- University of Erlangen-Nürnberg Medical School
Severe Hemophilia A
A Study of Repeat Dosing of PEG Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for Injection
Primary objective: To assess the pharmacokinetics, Safety and immunogenicity of Repeat Dosing of PEG Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for Injection With Severe Hemophilia A(FRSW117) Secondary…
- Trial name
- NCT05265286
- Testing
- FRSW117
- Where
- 5 sites in China
- Volunteers
- 15 people
- Sponsor
- Hangzhou Gensciences Biopharmaceutical Co., Ltd.
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