Clinical trials: Coagulation Abnormalities
Wiskott-Aldrich Syndrome (WAS), X-linked Thrombocytopenia
Interleukin-2 Treatment for Wiskott-Aldrich Syndrome
Funding Source--FDA OOPD. Orphan Product Grant Number--1R01FD004091-01A1 Context: Wiskott-Aldrich syndrome (WAS) is a fatal, devastating disease with ill-defined treatment modalities, which affects young boys.
- Trial name
- WAS (NCT00774358)
- Testing
- Interleukin-2
- Where
- 3 sites in United States
- Volunteers
- 9 people
- Sponsor
- Soma Jyonouchi
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
Wiskott-Aldrich Syndrome
Gene Therapy for WAS
This is a phase I/II study to evaluate the safety and efficacy of Hematopoietic Stem Cell genetherapy for the Wiskott-Aldrich Syndrome.
- Trial name
- NCT01347346
- Testing
- Autologous CD34 positive cells transduced with a lentiviral vector containing human WAS gene
- Where
- France
- Volunteers
- 5 people
- Sponsor
- Genethon
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
Hemophilia B
Safety of a New Type of Treatment Called Gene Transfer for the Treatment of Severe Hemophilia B
In this study a modified virus called adeno-associated virus (AAV) will be used to transfer a normal gene for human clotting factor IX into patients with severe hemophilia B (AAV human Factor IX vector).
- Trial name
- NCT00076557
- Testing
- Adeno-Associated Viral with Human Factor IX
- Where
- 3 sites in United States
- Volunteers
- 15 people
- Sponsor
- Avigen
Congenital Fibrinogen Deficiency, Afibrinogenemia
Pharmacokinetic, Efficacy, and Safety Study of Octafibrin Compared to Haemocomplettan/Riastap
The purpose of this study is to investigate pharmacokinetic properties, surrogate efficacy and safety of Octafibrin compared to Haemocomplettan® P/RiaSTAPTM in patients with congenital fibrinogen deficiency
- Trial name
- NCT01575756
- Testing
- Octafibrin, Haemocomplettan® P or RiaSTAPTM
- Where
- 10 sites in United States, Bulgaria and 4 more
- Volunteers
- 22 people
- Sponsor
- Octapharma
Raloxifene, Postmenopausal Women
Raloxifene on Coagulation System in the Postmenopausal Women
Objective: The aim of this study is to assess the effects of raloxifene HCl on coagulation parameters in healthy postmenopausal women.
- Trial name
- NCT04454775
- Testing
- coagulation system parameters; factor 8, von Willebrand factor, protein C, protein S, antithrombin III and fibrinogen were studied.
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Karadeniz Technical University
Premature Birth
The Trial of Pessary After Laser for TTTS
Placing a cervical pessary in severe twin-to-twin transfusion syndrome (TTTS) cases treated by fetoscopic laser coagulation (FLC) decreases the spontaneous preterm birth rate.
- Trial name
- PECEPLASER (NCT01334489)
- Testing
- Arabin Cervical Pessary
- Where
- 4 sites in Belgium, Germany and 1 more
- Volunteers
- 352 people
- Sponsor
- Hospital Universitari Vall d'Hebron Research Institute
Hemophilia B
A Study to Evaluate the Safety and Efficacy of ZS801 in Adult Hemophilia B Patients
A non-randomized, open-label, dose-escalation, phase I/II study to evaluate the safety, tolerability, kinetics and efficacy of a single intravenous infusion of ZS801 in hemophilia B subjects with endogenous FIX ≤2%.
- Trial name
- NCT05641610
- Testing
- ZS801
- Where
- China
- Volunteers
- 21 people
- Sponsor
- Institute of Hematology & Blood Diseases Hospital, China
Hemophilia A
Retrospective Study in Chinese Pediatric Hemophilia A Patients With rFⅧ Contained Regular Prophylaxis
To assess and describe real-life treatment choices for rFⅧ contained regular prophylaxis/bleeding prevention treatment in pediatric hemophilia patients in China (2007-2013)
- Trial name
- ReCARE (NCT02263066)
- Testing
- BAY14-2222_Kogenate-FS FVIII
- Where
- China
- Volunteers
- 181 people
- Sponsor
- Bayer
Hemophilia A, Hemophilia B
Personalized Medicine for Canadians With Hemophilia
Performing an individual pharmacokinetic (PK) estimate is only the first step in implementing tailored prophylaxis, which requires using the PK profile information to design a personalized treatment regimen matching the treatment…
- Trial name
- PMCH (NCT03615053)
- Testing
- Implementation of WAPPS-Hemo personalized dosing regimen
- Where
- 7 sites in Canada
- Volunteers
- 600 people
- Sponsor
- McMaster University
Hemophilia A
Study to Evaluate the Efficacy and Safety of Valoctocogene Roxaparvovec, With Prophylactic Steroids in Hemophilia A
This Phase III clinical study will evaluate the safety and effectiveness of valoctocogene roxaparvovec in combination with prophylactic corticosteroids in patients with severe hemophilia A.
- Trial name
- GENEr8-3 (NCT04323098)
- Testing
- valoctocogene roxaparvovec
- Where
- 12 sites in United States, Australia and 2 more
- Volunteers
- 22 people
- Sponsor
- BioMarin Pharmaceutical
Haemophilia
Effectiveness of Psychological Interventions in Haemophilia
The purpose of this study is to evaluate the relative effectiveness of two psychological interventions, cognitive-behavioral therapy (CBT) and hypnosis (Hyp), in preventing and managing pain, regulating emotional state and…
- Trial name
- PSY_HaEMOPEQ (NCT02870452)
- Testing
- Hypnosis, Cognitive-Behavioral Therapy
- Where
- Portugal
- Volunteers
- 20 people
- Sponsor
- University of Minho
Hemophilia B
An Observational Cohort Study to Characterize the Effectiveness and Safety of HEMGENIX® in Patients With Hemophilia B
This observational, post-authorization, long-term follow-up study aims to investigate the short and long-term effectiveness and safety of HEMGENIX in patients with hemophilia B.
- Trial name
- IX-TEND 4001 (NCT06008938)
- Testing
- HEMGENIX, Factor IX (FIX)
- Where
- 12 sites in United States, Austria and 5 more
- Volunteers
- 500 people
- Sponsor
- CSL Behring
Hemophilia B, Hemophilia A
A Study to Evaluate Prospective Efficacy and Safety Data of Current FIX Prophylaxis Replacement Therapy in Adult Hemophilia B Subjects (FIX:C≤2%) or Current FVIII Prophylaxis Replacement Therapy in Adult Hemophilia A Subjects (FVIII:C≤1%)
To establish baseline prospective efficacy data of current FIX prophylaxis replacement therapy in the usual care setting of hemophilia B subjects, who are negative for nAb to AAV-Spark100, prior to the Phase 3 gene therapy study.
- Trial name
- NCT03587116
- Testing
- Standard of Care FIX Replacement therapy, Standard of Care FVIII Replacement therapy
- Where
- 75 sites in United States, Australia and 16 more
- Volunteers
- 212 people
- Sponsor
- Pfizer
Hemophilia B
A Safety, Efficacy and Pharmacokinetics Study of a Recombinant Fusion Protein Linking Coagulation Factor IX With Albumin (rIX-FP) in Children With Hemophilia B
This study will examine the pharmacokinetics, safety and efficacy of rIX-FP for the control and prevention of bleeding episodes in children who have previously received factor replacement therapy for hemophilia B.
- Trial name
- NCT01662531
- Testing
- rIX-FP
- Where
- 17 sites in Australia, Austria and 8 more
- Volunteers
- 27 people
- Sponsor
- CSL Behring
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