Clinical trials: Coagulation Protein Disorders
Von Willebrand Disease
A Study to Compare the Pharmacokinetics and Safety of Current Factor VIII Concentrate and Optivate® in Haemophilia A.
The main objective of the study is to compare the pharmacokinetics of Optivate® with the subject's current FVIII concentrate when given as a bolus dose of 50IU/kg.
- Trial name
- NCT02246881
- Testing
- Optivate® (Human Coagulation Factor VIII)
- Where
- 8 sites in Poland, United Kingdom
- Sponsor
- Bio Products Laboratory
Hemophilia A
Optimizing the Use of Prophylaxis in Patients With Severe Haemophilia A
MyPKFiT is a web-based application recently developed by Baxalta for the use in patients treated with Advate. MyPkFit has its basis in Bayesian forecasting, which allows estimation of individual PK parameters by a sparse sampling…
- Trial name
- myPKFiT (NCT03915080)
- Testing
- Oktokog alpha
- Where
- Sweden
- Volunteers
- 14 people
- Sponsor
- Lund University
Immune Thrombocytopenic Purpura ( ITP ), HIV Infections
A Phase I Study of Recombinant Human CD4 Immunoglobulin G (rCD4-lgG) in Patients With HIV-Associated Immune Thrombocytopenic Purpura
To test the effectiveness of recombinant human CD4 Immunoglobulin G (CD4-IgG) in the treatment of HIV-associated immune thrombocytopenic purpura in patients with all levels of HIV infection.
- Trial name
- NCT00002250
- Testing
- CD4-IgG
- Where
- United States
- Sponsor
- Genentech, Inc.
Joint Disease
Key Aspects of Medical Practice in Patients With Haemophilia A
The KAPPa project has the aim to create an international database in which information about clinical features, therapeutic management, burden of illness and costs of severe and moderate haemophilia A patients from different…
- Trial name
- KAPPA (NCT02996942)
- Testing
- Factor VIII replacement
- Sponsor
- Lund University
Hemophilia A
Study of Safety And Efficacy Of ReFacto AF In Previously Untreated Hemophilia A Patients In The Usual Care Setting
Study to evaluate the safety and effectiveness of ReFacto AF for the treatment of severe hemophilia A in patients who have not yet received treatment for their hemophilia.
- Trial name
- NCT00950170
- Testing
- Laboratory Tests
- Where
- 11 sites in France, Germany and 5 more
- Volunteers
- 23 people
- Sponsor
- Pfizer
Hemophilia A With Inhibitors
rFVIIa Prophylaxis in Children With Hemophilia A and Inhibitors
The study evaluates the efficacy and safety of a prophylactic treatment with recombinant activated FVII in reducing the frequency of joint bleeds and the development of joint damage in children with hemophilia A who develop…
- Trial name
- ENJOIH (NCT01105546)
- Testing
- recombinant activated factor VII
- Where
- 15 sites in United States, France and 4 more
- Volunteers
- 50 people
- Sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Von Willebrand Diseases
ATHN 9: Severe VWD Natural History Study
ATHN 9 is a natural history study to assess the safety of various Von Willebrand Factor (VWF) regimens for different indications (on-demand, surgery and prophylaxis) in adult and pediatric participants with clinically severe…
- Trial name
- NCT03853486
- Where
- 22 sites in United States
- Volunteers
- 108 people
- Sponsor
- American Thrombosis and Hemostasis Network
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
Multiple Sclerosis, Relapse
Observational Trial Evaluating Elevated Factor VIII Related Labs as a Biomarker for Incomplete Relapse Recovery
Nine Multiple Sclerosis (MS) patients suffering an acute relapse from the outpatient or inpatient settings will be consented to be followed prospectively for three months post relapse, in an effort to identify markers of…
- Trial name
- NCT05926167
- Testing
- blood tests drawn days 1, 8, 22 and 90 of the study
- Volunteers
- 9 people
- Sponsor
- Dignity Health Medical Foundation
Hemophilia A
Clinical and Health-related Outcome of rFVIIIFc Prophylaxis
Current standard therapy for patients with haemophilia (PwH) in the prevention of bleeding episodes is a prophylactic intravenous treatment with recombinant coagulation factor (F) VIII (Haemophilia A) or rather FIX (Haemophilia…
- Trial name
- CLHEAR (NCT04583930)
- Where
- 2 sites in Germany
- Volunteers
- 48 people
- Sponsor
- Prof. Dr. Dr. Thomas Hilberg
Hemophilia A
Non-interventional Post-authorisation Study to Document the Immunogenicity, Safety, and Efficacy of NUWIQ
Prospective, multinational, non-interventional post-authorisation study to collect additional clinical data and to ensure consistency in the long-term between the outcome from pre-authorisation clinical studies (in 135 previously…
- Trial name
- NCT02962765
- Where
- 39 sites in United States, Argentina and 11 more
- Volunteers
- 80 people
- Sponsor
- Octapharma
Hemophilia, Hemophilia A
Improved Factor VIII Inhibitor Evaluation
Commercial one and two-stage factor VIII assays may not detect some clinically significant inhibitor antibodies. The purpose of the proposed study is to standardize and validate a platelet-based factor VIII activity assay with…
- Trial name
- IFIE (NCT02726139)
- Where
- United States
- Sponsor
- Boston VA Research Institute, Inc.
Hemophilia A or B With Inhibitors, Hemophilia A
Efficacy and Safety Study of Prophylactic Versus On-Demand Treatment With Feiba NF in Subjects With Hemophilia A or B and a High Titer Inhibitor
The purpose of the study was to determine the efficacy, safety, and health-related quality of life benefits with FEIBA NF prophylactic treatment as compared with on-demand treatment.
- Conditions
- Hemophilia A or B With Inhibitors, Hemophilia A, Hemophilia B
- Trial name
- NCT00851721
- Testing
- Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated)
- Where
- 17 sites in United States, Brazil and 8 more
- Volunteers
- 52 people
- Sponsor
- Baxalta now part of Shire
Reversal of Anticoagulant Treatment
Study of Octaplex (Human Prothrombin Complex Concentrate) and Fresh Frozen Plasma in Patients Under Vitamin K Therapy Antagonist Needing Urgent Surgery or Invasive Procedures
The purpose of this study is to determine whether Octaplex (human prothrombin complex concentrate) can reverse the effects of anticoagulants when compared to the standard treatment of fresh frozen plasma (FFP).
- Trial name
- NCT00618098
- Testing
- Octaplex (human prothrombin complex concentrate), Fresh frozen plasma
- Where
- United States
- Volunteers
- 200 people
- Sponsor
- Octapharma
Factor XIII Deficiency
An Open Enrollment Study of Factor XIII Concentrate in Subjects With Congenital Factor XIII Deficiency
Congenital deficiency of factor XIII is an extremely rare inherited disorder associated with potentially life-threatening bleeding. Factor XIII Concentrate is given to patients whose blood is lacking factor XIII.
- Trial name
- NCT00945906
- Testing
- FXIII Concentrate (Human) (FXIII)
- Where
- 25 sites in United States
- Volunteers
- 61 people
- Sponsor
- CSL Behring
Hemophilia
BAY14-2222 Continuous Infusion in Surgeries
Phase III study, to evaluate the efficacy and safety of continuous infusion of rFVIII-FS in the treatment of patients with hemophilia A undergoing major elective surgery by achieving the required therapeutic concentrations.
- Trial name
- NCT00606060
- Testing
- Kogenate (BAY14-2222)
- Where
- Israel
- Volunteers
- 15 people
- Sponsor
- Bayer
Hemophilia A, Hemophilia A and B
A Phase III Clinical Trial Evaluating SR604 Injection for Prophylactic Treatment in Patients With Hemophilia
This is a single-arm, multicenter Phase III clinical trial designed to evaluate the efficacy and safety of prophylactic treatment with SR604 Injection in hemophilia A/B patients with or without inhibitors.
- Conditions
- Hemophilia A, Hemophilia A and B, Hemophilia B
- Trial name
- NCT07876674
- Testing
- SR604
- Volunteers
- 90 people
- Sponsor
- Shanghai RAAS Blood Products Co., Ltd.
Hemophilia A
Prevention of Bleeding in Patients With Moderate and Severe Hemophilia A Playing Sports: A Comparison Between Factor VIII and Emicizumab Prophylaxis
Hemophilia A (HA) is a genetic bleeding disorder resulting from a deficiency or absence of factor VIII (FVIII), which is necessary in the clotting process.
- Trial name
- STEP (NCT05022459)
- Testing
- Emicizumab, FVIII
- Where
- 10 sites in United States
- Volunteers
- 72 people
- Sponsor
- Wayne State University
Thrombosis
A Study to Investigate Biomarkers After Single Doses of Anticoagulants in Healthy Young Male and Healthy Elderly Participants (MK-0000-216 AM1)
This is a study to investigate biomarkers after single oral doses of the anticoagulant agents dabigatran etexilate and rivaroxaban in healthy young male subjects and in healthy elderly subjects.
- Trial name
- NCT01379300
- Testing
- dabigatran etexilate, rivaroxaban
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Intracranial Hemorrhage, Traumatic, Intracranial Hemorrhage, Spontaneous
FFP Versus PCC in Intracranial Hemorrhage
The goal of this study will be to determine whether PCC confers any benefits over FFP in traumatic and spontaneous intracranial hemorrhage with respect to multiple factors including time to correction, absolute international…
- Trial name
- NCT02429453
- Testing
- Four Factor Prothrombin Complex Concentrate, Fresh Frozen Plasma
- Where
- United States
- Sponsor
- University of Utah
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