Clinical trials: Disorders, Blood Coagulation
Afibrinogenemia, Hypofibrinogenemia
Fibrinogen Concentrate (Human) - Efficacy and Safety Study
This is a multinational, multicenter, prospective, open-label historically controlled Phase IIIb non-inferiority clinical trial on the efficacy and safety of Fibrinogen Concentrate (Human).
- Conditions
- Afibrinogenemia, Hypofibrinogenemia, Fibrinogen Deficiency
- Trial name
- NCT00916656
- Testing
- Fibrinogen Concentrate, Human (FCH), Cryoprecipitate
- Sponsor
- CSL Behring
Hemophilia A, Hemophilia B
An 18-month Low-interventional Study to Assess Joint Health in Haemophilia A and B Patients on Prophylaxis With Efmoroctocog Alfa or Eftrenonacog Alfa
The goal of this low-interventional study is to describe the overall joint health in patients with haemophilia A or haemophilia B prophylactically treated with rFVIIIFc or rFIXFc.
- Trial name
- JOIN-us (NCT05856266)
- Testing
- Haemophilia Early Arthropathy Detection with Ultrasound (HEAD-US), Haemophilia Joint Health Score (HJHS)
- Where
- 56 sites in Bulgaria, Croatia and 9 more
- Volunteers
- 10 people
- Sponsor
- Swedish Orphan Biovitrum
Hemophilia B
Post-Marketing Surveillance (Usage Results Study) of RIXUBIS in Adult and Pediatric Patients With Haemophilia B in South Korea
Primary: To characterize the safety of RIXUBIS when used under normal clinical care in South Korea. Secondary: To describe hemostatic effectiveness in subjects receiving RIXUBIS under normal clinical care in South Korea.
- Trial name
- NCT02922231
- Testing
- RIXUBIS
- Where
- 5 sites in South Korea
- Volunteers
- 57 people
- Sponsor
- Baxalta now part of Shire
Healthy
Study to Evaluate CAY001 in Healthy Volunteers
This is a Phase 1, first-in-human, randomized, double-blind, placebo-controlled, single ascending dose, sequential group study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of CAY001 when…
- Trial name
- NCT06845839
- Testing
- CAY001
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Cayuga Biotech, Inc.
Hemophilia A
Pharmacokinetics, Efficacy and Safety Study of IMMUNATE SD (Human Plasma-Derived Coagulation Factor VIII Concentrate) in Hemophilia A Patients
The purpose of this study is to evaluate whether IMMUNATE S/D is effective and safe in the treatment of hemophilia A patients. The study consists of 3 parts: Part 1 is a pharmacokinetic comparison of IMMUNATE S/D and its…
- Trial name
- NCT00162019
- Testing
- Human Plasma-Derived Coagulation Factor VIII Concentrate (Virus Inactivated by Polysorbate 80 Treatment and Vapor Heat Treatment)
- Where
- 5 sites in Bulgaria, Czechia and 2 more
- Volunteers
- 56 people
- Sponsor
- Baxalta now part of Shire
Hemophilia B
Pivotal Study (Pharmacokinetics, Efficacy, Safety) of BAX 326 (rFIX) in Hemophilia B Patients
The purpose of this pivotal Phase 1/3 study is to determine the pharmacokinetic (PK) parameters, the hemostatic efficacy, and the safety of BAX 326, a recombinant factor IX, in previously treated patients (PTPs) with severe and…
- Trial name
- NCT01174446
- Testing
- BAX 326, BeneFIX
- Where
- 25 sites in Argentina, Brazil and 12 more
- Volunteers
- 86 people
- Sponsor
- Baxalta now part of Shire
Acquired Thrombotic Thrombocytopenic Purpura
Follow-up Study for Patients Who Completed Study ALX0681-C301 (Post-HERCULES)
The objectives of this study were to evaluate long-term safety and efficacy of caplacizumab, to evaluate safety and efficacy of repeated use of caplacizumab and to characterize long-term impact of acquired thrombotic…
- Trial name
- NCT02878603
- Testing
- Caplacizumab, Standard of Care
- Where
- 45 sites in United States, Austria and 11 more
- Volunteers
- 104 people
- Sponsor
- Sanofi
Hemophilia B
Phase I/IIa Study of FIXFc in Hemophilia B Patients
The primary objective of the study is to assess safety of FIXFc at doses ranging from 1 to 100 IU/kg.
- Trial name
- NCT00716716
- Testing
- rFIXFc
- Where
- 6 sites in United States
- Volunteers
- 10 people
- Sponsor
- Bioverativ Therapeutics Inc.
Von Willebrand Disease, Type 3
A Study to Assess the Efficacy and Safety of Emicizumab in Participants With Type 3 Von Willebrand Disease
This is a Phase III, multicenter, open-label clinical study designed to evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of emicizumab prophylaxis in participants aged 1 month and above, who have been…
- Trial name
- WILL-EMI (NCT06998524)
- Testing
- Emicizumab, von Willebrand Factor (VWF) Concentrates, Factor VIII (FVIII) Concentrates
- Where
- 29 sites in United States, Belgium and 12 more
- Volunteers
- 75 people
- Sponsor
- Hoffmann-La Roche
Immune Thrombocytopenia (ITP)
Evaluating the Pharmacokinetics and Pharmacodynamics of Romiplostim in Patients With Immune Thrombocytopenia (ITP)
The objective of evaluating the pharmacokinetics and pharmacodynamics of romiplostim in patients with immune thrombocytopenia.
- Trial name
- NCT02868060
- Testing
- Romiplostim
- Where
- 5 sites in China
- Volunteers
- 16 people
- Sponsor
- Kyowa Kirin China Pharmaceutical Co., Ltd.
Hemophilia A, Gene Therapy
Gene Therapy Study in Severe Hemophilia A Patients With Antibodies Against AAV5
This study is being conducted by BioMarin Pharmaceutical Inc. as an open label, single dose study to determine the safety of valoctocogene roxaparvovec (an Adenovirus-Associated Virus (AAV) based gene therapy vector) in severe…
- Conditions
- Hemophilia A, Gene Therapy, Clotting Disorders, Blood Disorder
- Trial name
- GENEr8-AAV5+ (NCT03520712)
- Testing
- Valoctocogene Roxaparvovec
- Where
- 9 sites in South Africa, South Korea and 2 more
- Volunteers
- 3 people
- Sponsor
- BioMarin Pharmaceutical
Hemophilia B
Hemophilia B Gene Therapy With AAV8 Vector
Hemophilia B is a bleeding disease in males due to very low levels of coagulation factor IX (FIX) in the blood. The current treatment is intravenous injection of FIX clotting factor concentrates, in response to bleeding.
- Trial name
- NCT01620801
- Testing
- AAV8-hFIX19
- Where
- 3 sites in United States, Australia
- Volunteers
- 4 people
- Sponsor
- Spark Therapeutics, Inc.
Hemophilia a, Hemophilia B
Hemophilia Non-Interventional Study Prior to SerpinPC Intervention (PRESent-5)
The primary objective of this study is to obtain prospective baseline documentation of annualized bleeding rates (ABRs) and treatment under standard-of-care (SOC) therapy among participants with hemophilia A or B.
- Trial name
- NCT05605678
- Testing
- No Intervention
- Where
- 45 sites in United States, Armenia and 14 more
- Volunteers
- 108 people
- Sponsor
- ApcinteX Ltd
Hemophilia A
Single Dose Study in Subjects With Severe Hemophilia A Comparing Pharmacokinetic Parameters for BAY81-8973 and Advate
The purpose of this study is to compare the pharmacokinetics of BAY81-8973 and Advate after intravenous administration.
- Trial name
- NCT02483208
- Testing
- BAY81-8973, Advate
- Where
- Bulgaria
- Volunteers
- 18 people
- Sponsor
- Bayer
Immune Thrombocytopenic Purpura
Treatment of Chronic Immune Thrombocytopenic Purpura (ITP) With Intravenous Immunoglobulin IgPro10
The purpose of this study is to evaluate the efficacy, tolerability and safety of IgPro10 in the treatment of patients with chronic immune thrombocytopenic purpura (ITP).
- Trial name
- NCT00168038
- Testing
- Immunoglobulin Intravenous (Human)
- Where
- 17 sites in Germany, Italy and 4 more
- Volunteers
- 58 people
- Sponsor
- CSL Behring
Blood Coagulation Disorders, Thrombotic Disorders
Determination of Fibrin Activity in Plasma on STA-R® Prototype
The purpose of the study is to give the proof of concept of the Fibrin structure assay on STA-R® prototype. It aims to identify the parameters which discriminate the pathologic from the normal population.
- Conditions
- Blood Coagulation Disorders, Thrombotic Disorders, Hemorrhagic Disorders, Trauma
- Trial name
- FAST (NCT02856789)
- Testing
- Routine hemostasis tests, Fibrin structure (FS), Thromboelastography (TEG)
- Where
- France
- Volunteers
- 913 people, healthy volunteers welcome
- Sponsor
- Diagnostica Stago R&D
Hemophilia
Safety and Efficacy of FVIIa to Prevent Excessive Bleeding in Hemophilia Patients With Inhibitors Undergoing Major Surgery
This is an interventional, prospective, international, multicenter, single-arm, Phase 3, and sequential efficacy and safety study in adolescents and adults with congenital hemophilia A or B with inhibitors to factor VIII (FVIII)…
- Trial name
- SCOPE HIM (NCT05695391)
- Testing
- Coagulation Factor VIIa (Recombinant)
- Where
- 15 sites in United States, Malaysia and 4 more
- Volunteers
- 2 people
- Sponsor
- Laboratoire français de Fractionnement et de Biotechnologies
Haemophilia A
A Study Following Males With Haemophilia A on Prophylaxis With Esperoct®
This study will collect information on side effects and how well Esperoct® (turoctocog alfa pegol (N8-GP)) works during long-term treatment (prophylaxis) in males with haemophilia A.
- Trial name
- pathfinder9 (NCT04574076)
- Testing
- Turoctocog alfa pegol (N8-GP)
- Where
- 27 sites in Austria, Bulgaria and 13 more
- Volunteers
- 60 people
- Sponsor
- Novo Nordisk A/S
Hemophilia A and B
Multiple Escalating Dose Study of BAY1093884 in Adults With Hemophilia A or B With or Without Inhibitors
The purpose of this study was to assess the safety and tolerability of multiple doses of a human monoclonal antibody (BAY1093884) given under the skin in subjects with hemophilia A or B.
- Trial name
- NCT03597022
- Testing
- Befovacimab (BAY1093884)
- Where
- 17 sites in Australia, Austria and 9 more
- Volunteers
- 24 people
- Sponsor
- Bayer
Hemophilia B
Safety and Dose Finding Study of DTX101 (AAVrh10FIX) in Adults With Moderate/Severe to Severe Hemophilia B
A Phase 1/2, open-label, dose-finding safety study of single ascending doses of DTX101 in adult males with moderate/severe to severe hemophilia B.
- Trial name
- NCT02618915
- Testing
- DTX101
- Where
- 9 sites in United States, Bulgaria and 1 more
- Volunteers
- 6 people
- Sponsor
- Ultragenyx Pharmaceutical Inc
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