Clinical trials: Coagulation Protein Disorders
Von Willebrand Disease
IL-11 in Women With Von Willebrand Disease and Refractory Menorrhagia
The purpose of this study is to determine the efficacy and safety of rhIL-11, when given subcutaneously for six consecutive months, in reducing menstrual blood loss in women with type 1 von Willebrand disease and refractory…
- Trial name
- NCT00524342
- Testing
- Oprelvekin, Interleukin 11, IL-11
- Where
- United States
- Volunteers
- 7 people
- Sponsor
- Margaret Ragni
Severe Hemophilia A
Hemophilia Adult Prophylaxis Study: Factor VIII in Severe Hemophilia A
The purpose of this pilot R34 trial is to determine the feasibility of a large single dose Phase III study of hemophilia adult prophylaxis comparing once weekly with thrice-weekly recombinant factor VIII.
- Trial name
- NCT01405742
- Testing
- rF.VIII
- Where
- 6 sites in United States
- Volunteers
- 4 people
- Sponsor
- University of Pittsburgh
Healthy Volunteers, Hemophilia A
A Study to Investigate the Pharmacokinetics, Safety, and Tolerability of Emicizumab in Healthy Chinese Volunteers
This single-center, open-label study will evaluate the pharmacokinetics, safety, and tolerability of emicizumab following a single subcutaneous (SC) administration to healthy Chinese subjects.
- Trial name
- NCT03380780
- Testing
- Emicizumab
- Where
- China
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Factor VIII Deficiency, Congenital, Factor 8 Deficiency, Congenital
Post-Marketing Surveillance To Observe Safety And Efficacy Of Xyntha Solofuse Prefilled Syringe
This study aims to observe the safety and efficacy of the Xyntha Solofuse prefilled syringe in the setting of routine practice. The primary objective is to detect medically significant events (factor VIII inhibitor).
- Conditions
- Factor VIII Deficiency, Congenital, Factor 8 Deficiency, Congenital, Autosomal Hemophilia A, Classic Hemophilia
- Trial name
- NCT03034044
- Volunteers
- 106 people
- Sponsor
- Pfizer
Von Willebrand Disease
Efficacy, PK, Immunogenicity and Safety of Wilate in Severe Von Willebrand Disease (VWD) Patients <6 Years of Age
The WIL-33 study aimed to determine the efficacy, pharmacokinetics, immunogenicity and safety of wilate as routine prophylaxis in up to 12 paediatric patients (eight evaluable) with severe von Willebrand Disease VWD (defined as…
- Trial name
- NCT04953884
- Testing
- Wilate
- Where
- 9 sites in United States, Czechia and 5 more
- Volunteers
- 12 people
- Sponsor
- Octapharma
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
Coagulopathy
Trial of RiaSTAP Versus Cryoprecipitate to Lower Operative Transfusions
The study aligns with the strategic plan of New York-Presbyterian Hospital (NYPH) to reduce allogeneic blood product use and decrease unnecessary laboratory costs.
- Trial name
- TOP-CLOT (NCT02540434)
- Testing
- ROTEM, Cryoprecipitate, RiaSTAP
- Where
- United States
- Volunteers
- 19 people
- Sponsor
- Weill Medical College of Cornell University
Severe Hemophilia A
Safety Study of Alphanate in Previously Treated Patients With Severe Hemophilia A
The purpose of this study is to determine the immunologic and overall safety associated with long-term use of Alphanate in subjects diagnosed with severe hemophilia A (Factor VIII:C less than 0.01 IU/ml), who have been previously…
- Trial name
- NCT00323856
- Testing
- Alphanate SD/HT
- Where
- 2 sites in Poland
- Volunteers
- 51 people
- Sponsor
- Grifols Biologicals, LLC
Hemophilia B
HOPE-B: Trial of AMT-061 in Severe or Moderately Severe Hemophilia B Patients
This is an open-label, single-dose, multi-center, multinational trial to demonstrate the efficacy of AMT-061 and to further describe its safety profile. The study drug is identified as AAV5-hFIXco-Padua (AMT- 061).
- Trial name
- NCT03569891
- Testing
- AAV5-hFIXco-Padua, Factor IX (FIX)
- Where
- 33 sites in United States, Belgium and 6 more
- Volunteers
- 67 people
- Sponsor
- CSL Behring
Hemophilia A or B
PF-06741086 Multiple Dose Study in Severe Hemophilia
This study is designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of multiple subcutaneous and/or intravenous doses of PF-06741086 in subjects with severe hemophilia.
- Trial name
- NCT02974855
- Testing
- PF-06741086
- Where
- 10 sites in United States, Chile and 4 more
- Volunteers
- 27 people
- Sponsor
- Pfizer
Hemophilia A
Prophylaxis Versus on Demand Treatment for Children With Hemophilia A
Comparison of the effect of three times a week prophylaxis on all bleeds with on-demand treatment for children with severe Hemophilia A.
- Trial name
- NCT01810666
- Testing
- Recombinant Factor VIII (Kogenate FS, BAY14-2222)
- Where
- 5 sites in China
- Volunteers
- 30 people
- Sponsor
- Bayer
Von Willebrand Diseases
Minimize Menorrhagia in Women With Von Willebrand Disease
This is an outpatient, 24-week Phase III prospective, randomized, crossover trial comparing recombinant von Willebrand factor (rVWF) and tranexamic acid (TA, Lysteda®) to minimize menorrhagia in women with von Willebrand disease…
- Trial name
- VWDMin (NCT02606045)
- Testing
- recombinant von Willebrand factor, tranexamic acid
- Where
- 19 sites in United States
- Volunteers
- 39 people
- Sponsor
- Margaret Ragni
Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Acute Leukemia in Remission
Fludarabine Phosphate, Cyclophosphamide, Total Body Irradiation, and Donor Stem Cell Transplant in Treating Patients With Blood Cancer
This phase II trial studies how well fludarabine phosphate, cyclophosphamide, total body irradiation, and donor stem cell transplant work in treating patients with blood cancer.
- Conditions
- Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Acute Leukemia in Remission, Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia
- Trial name
- NCT03333486
- Testing
- Cyclophosphamide, Fludarabine Phosphate, Laboratory Biomarker Analysis
- Where
- United States
- Volunteers
- 31 people
- Sponsor
- Roswell Park Cancer Institute
Hypofibrinogenemia, Bleeding
Transfusion of Pathogen Reduced Cryoprecipitated Fibrinogen to Expedite Product Availability in Perioperative Bleeding
The goal of this quality improvement study is to compare pathogen-reduced cryoprecipitate with traditional cryoprecipitate in liver transplant and cardiovascular patients.
- Trial name
- NCT05711524
- Testing
- Traditional Cryoprecipitate, Pathogen-Reduced Cryoprecipitate
- Where
- United States
- Volunteers
- 208 people, healthy volunteers welcome
- Sponsor
- Weill Medical College of Cornell University
Hemophilia B
A Study to Evaluate the Efficacy and Safety of Factor IX Gene Therapy With PF-06838435 in Adult Males With Moderately Severe to Severe Hemophilia B
This study will evaluate the efficacy and safety of PF-06838435 (a gene therapy drug) in adult male participants with moderately severe to severe hemophilia B (participants that have a Factor IX circulating activity of 2% or…
- Trial name
- BENEGENE-2 (NCT03861273)
- Testing
- PF-06838435/ fidanacogene elaparvovec
- Where
- 65 sites in United States, Australia and 14 more
- Volunteers
- 51 people
- Sponsor
- Pfizer
Hemophilia B
Evaluation of a Recombinant Factor IX Product, APVO101, in Previously-Treated Pediatric Patients With Hemophilia B
Phase 3/4, single arm, open-label study to evaluate PK, safety, and efficacy of APVO101 prophylaxis in severe or moderately severe hemophilia B subjects < 12 years of age.
- Trial name
- NCT03855280
- Testing
- APVO101
- Where
- 11 sites in Brazil, Georgia and 4 more
- Volunteers
- 21 people
- Sponsor
- Medexus Pharma, Inc.
Hemophilia B
An Open-Label, Single Dose Pharmacokinetic Study of Benefix (Recombinant Factor IX) in Male Chinese Subjects With Hemophilia B
The sample size of 12 male Chinese subjects are based on the CFDA requirement for a China PK study and to support the registration in China.
- Trial name
- NCT02213250
- Testing
- BENEFIX
- Where
- 2 sites in China
- Volunteers
- 12 people
- Sponsor
- Pfizer
Obstetric Labor Complications, Hemorrhage
Coagulation Factor Changes Associated With Postpartum Hysterectomies
The purpose of this study is to examine components of the coagulation system in women undergoing postpartum hysterectomy and to compare laboratory parameters of coagulation in these women to women at increased risk for a…
- Conditions
- Obstetric Labor Complications, Hemorrhage, Complications; Cesarean Section
- Trial name
- NCT00456547
- Testing
- Blood Draw
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Northwestern University
Von Willebrand Disease
Recombinant Von Willebrand Factor in Subjects With Severe Von Willebrand Disease Undergoing Surgery
The purpose of the study is to assess the efficacy and safety of recombinant von Willebrand factor (rVWF) with or without ADVATE in major and minor elective surgical procedures in adult patients with hereditary severe von…
- Trial name
- NCT02283268
- Testing
- Recombinant von Willebrand Factor (rVWF)
- Where
- 34 sites in United States, Australia and 11 more
- Volunteers
- 24 people
- Sponsor
- Baxalta now part of Shire
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