Clinical trials: Disorders, Blood Coagulation
Acquired Hemophilia A
Study of Modified Recombinant Factor VIII (OBI-1) in Subjects With Acquired Hemophilia A
This study is to test whether the study drug (OBI-1) is safe and effective for the treatment of serious bleeding episodes in people with acquired hemophilia A.
- Trial name
- NCT01178294
- Testing
- OBI-1
- Where
- 12 sites in United States, Canada and 2 more
- Volunteers
- 29 people
- Sponsor
- Baxalta now part of Shire
Hemophilia A
Study Evaluating Safety And Efficacy Of Moroctocog Alfa (AF-CC) In Previously Treated Hemophilia A Patients
The study will be investigating pharmacokinetics, safety and efficacy in patients less than 12 years of age with severe hemophilia A that have been previously treated with Factor VIII products ( including blood products).
- Trial name
- NCT00914459
- Testing
- Moroctocog alfa ( AF-CC), Laboratory tests
- Where
- 17 sites in Finland, Georgia and 7 more
- Volunteers
- 37 people
- Sponsor
- Pfizer
Primary Immunodeficiency Diseases (PID), Immune Thrombocytopenic Purpura (ITP)
Safety and Efficacy Study of a 10% Intravenous Immune Globulin Solution in Subjects With Primary Immunodeficiency Disorders
The purpose of this study is to assess the safety and efficacy of Immune Globulin Intravenous (Human), 10% (IGIV 10%) in subjects with primary immunodeficiency disorders.
- Conditions
- Primary Immunodeficiency Diseases (PID), Immune Thrombocytopenic Purpura (ITP), Kawasaki Syndrome
- Trial name
- NCT00157079
- Testing
- Immune Globulin Intravenous (Human), 10%
- Where
- 11 sites in United States
- Volunteers
- 61 people
- Sponsor
- Baxalta now part of Shire
Hemophilia B
BAX 326 Surgery Study in Hemophilia B Patients
The purpose of the study is to assess the hemostatic efficacy and safety of BAX 326 in subjects with severe (FIX level < 1%) or moderately severe (FIX level 1-2%) hemophilia B undergoing major or minor elective or emergency…
- Trial name
- NCT01507896
- Testing
- Recombinant factor IX
- Where
- 14 sites in Argentina, Bulgaria and 8 more
- Volunteers
- 30 people
- Sponsor
- Baxalta now part of Shire
Heart Disease, Focus is on Testing Performance of CORA Hemostasis System.
Equivalency Study of the TEG and CORA Hemostasis Systems
This study is being performed to obtain data about the CORA system, a new device that is currently being tested and is not yet cleared for sale in the United State by the Food and Drug Administration (FDA).
- Trial name
- NCT01790386
- Where
- 4 sites in United States
- Volunteers
- 465 people, healthy volunteers welcome
- Sponsor
- Coramed Technologies LLC
Purpura, Thrombocytopenic, Idiopathic, Autoimmune Thrombocytopenic Purpura
Study of Veltuzumab (hA20) at Different Doses in Patients With ITP
This trial will study different dose levels of hA20 (IMMU-106) to see if they are safe and effective for treating ITP.
- Conditions
- Purpura, Thrombocytopenic, Idiopathic, Autoimmune Thrombocytopenic Purpura, Purpura, Thrombocytopenic, Autoimmune
- Trial name
- NCT00547066
- Testing
- veltuzumab
- Where
- 8 sites in United States
- Volunteers
- 48 people
- Sponsor
- Gilead Sciences
Venous Thrombosis
Phase I Study of Direct Coagulation Factor Xa Inhibitor SYHA136 Tablets in Chinese Healthy Volunteers
The trial used single-center, randomized, double-blind, placebo-controlled, single-dose ascending study. The trial planned to enroll fifty-six healthy volunteers.
- Trial name
- NCT04036656
- Testing
- SYHA136 0.5 mg, SYHA136 1 mg, SYHA136 2.5 mg
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Bleeding Disorder, Hypofibrinogenemia; Acquired
Adjusted Fibrinogen Replacement Strategy
The main purpose of this study was to demonstrate the efficacy and safety of intraoperative use of fibrinogen concentrate BT524, as a complementary therapy for the management of uncontrolled severe hemorrhage in acquired…
- Trial name
- AdFIrst (NCT03444324)
- Testing
- BT524, FFP/Cryo
- Where
- 19 sites in Belgium, Czechia and 5 more
- Volunteers
- 222 people
- Sponsor
- Biotest
Primary Immune Thrombocytopenia
A Study to Evaluate the Efficacy, Safety, and Tolerability of Rozanolixizumab in Adult Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP)
The purpose of this study is to demonstrate the clinical efficacy of rozanolixizumab in maintenance treatment and assess safety and tolerability of rozanolixizumab in adult study participants with primary immune thrombocytopenia…
- Trial name
- myOpportunITy1 (NCT04200456)
- Testing
- Rozanolixizumab
- Where
- 29 sites in United States, Bulgaria and 14 more
- Volunteers
- 33 people
- Sponsor
- UCB Biopharma SRL
Thrombotic Thrombocytopenic Purpura
A Trial of Caplacizumab in Japanese Patients With Acquired Thrombotic Thrombocytopenic Purpura (aTTP)
Primary Objective: To evaluate the effect of caplacizumab on prevention of recurrence of aTTP (proportion of participants with a recurrence of aTTP) during the overall study period.
- Trial name
- NCT04074187
- Testing
- Caplacizumab (ALX-0081), Plasma exchange (PE), Corticosteroid treatment (Methylprednisolone or prednisolone)
- Where
- 12 sites in Japan
- Volunteers
- 21 people
- Sponsor
- Sanofi
Significant Bleeding Risk
Study of Octaplex, a Four-factor Prothrombin Complex Concentrate (4F-PCC) and Beriplex® P/N (Kcentra) for the Reversal of Vitamin K Antagonist (VKA) Induced Anticoagulation in Patients Needing Urgent Surgery With Significant Bleeding Risk.
To demonstrate that the efficacy of OCTAPLEX as a reversal agent in patients under Vitamin K Antagonist (VKA) therapy with the need for urgent surgery with significant bleeding risk is clinically non-inferior to that Beriplex®…
- Trial name
- NCT02740335
- Testing
- Octaplex, Beriplex P/N (Kcentra)
- Where
- 86 sites in United States, Belarus and 9 more
- Volunteers
- 208 people
- Sponsor
- Octapharma
Hemophilia B
A Study to Investigate the Safety and Effectiveness of a Coagulation Factor IX Gene Insertion Therapy (REGV131-LNP1265) in Pediatric, Adolescent and Adult Participants With Hemophilia B
Participants in this study have a genetic mutation, specifically in the coagulation (blood clotting) Factor 9 gene that causes severe or moderately severe hemophilia B.
- Trial name
- BEYOND-9 (NCT06379789)
- Testing
- REGV131, LNP1265
- Where
- 52 sites in United States, Australia and 7 more
- Volunteers
- 130 people
- Sponsor
- Regeneron Pharmaceuticals
Congenital Bleeding Disorder, Haemophilia A With Inhibitors
Efficacy of NovoSeven® in Bleeding Prophylaxis in Hemophilia
This trial is conducted in Africa, Asia, Europe, South America, and the United States of America (USA). The purpose of this study is to evaluate the effectiveness of secondary prophylactic treatment with NovoSeven® in haemophilia…
- Conditions
- Congenital Bleeding Disorder, Haemophilia A With Inhibitors, Haemophilia B With Inhibitors
- Trial name
- NCT00108758
- Testing
- activated recombinant human factor VII
- Where
- 37 sites in United States, Argentina and 10 more
- Volunteers
- 23 people
- Sponsor
- Novo Nordisk A/S
Pancreatic Cancer, Ductal Adrenocarcinoma
Study of Safety and Tolerability of PCI-27483 in Patients With Pancreatic Cancer Patients Receiving Treatment With Gemcitabine
The purpose of this study is to evaluate the safety and tolerability of selected dose 1.2mg/kg BID dosage administered subcutaneously (SC) administered PCI-27483 to metastatic or locally advanced pancreatic cancer patients…
- Conditions
- Pancreatic Cancer, Ductal Adrenocarcinoma, Exocrine Pancreatic Cancer
- Trial name
- NCT01020006
- Testing
- PCI-27483, Gemcitabine
- Where
- 17 sites in United States
- Volunteers
- 42 people
- Sponsor
- Pharmacyclics LLC.
Anticoagulants and Bleeding Disorders
Evaluating LumiraDx INR Test Accuracy in Patients Taking Phenprocoumon Anticoagulant.
This study is to evaluate the INR levels in patients taking phenprocoumon using the LumiraDx Point of Care INR test and comparing the results to the laboratory reference method , the ACL Elite Pro.
- Trial name
- VKA_GERMANY (NCT04074980)
- Testing
- Venous and Fingerstick blood draws, Venous blood draw
- Where
- Germany
- Volunteers
- 102 people
- Sponsor
- LumiraDx UK Limited
Coagulation, Therapeutic Uses
Hemostatic Closure of Femoral Artery Access Site, Using the QuickClose Design 9 System
The QuickClose Design 9 is a prospective, non randomized study, to evaluate the safety and efficacy of the QuickClose design 9 closure device.
- Conditions
- Coagulation, Therapeutic Uses, Pharmacologic Actions
- Trial name
- NCT01121510
- Testing
- closure device
- Where
- Israel
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- CardioDex
Hemophilia B
Ascending Dose Study of Genome Editing by Zinc Finger Nuclease Therapeutic SB-FIX in Subjects With Severe Hemophilia B
The purpose of the study is to evaluate the safety, tolerability and effect on FIX antigen and activity levels of ascending doses of SB-FIX.
- Trial name
- NCT02695160
- Testing
- SB-FIX
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Sangamo Therapeutics
Severe Hemophilia A
Study of Recombinant Human Coagulation Factor VIII-Fc Fusion Protein (FRSW107) On-Demand Treatment
The indication for this product is to control bleeding in patients with hemophilia A (congenital deficiency of factor VIII). The primary objective: Evaluation of the efficacy of recombinant human coagulation factor VIII-Fc fusion…
- Trial name
- NCT07663903
- Testing
- FRSW107
- Where
- 24 sites in China
- Volunteers
- 60 people
- Sponsor
- Hangzhou Gensciences Biopharmaceutical Co., Ltd.
Polycythemia Vera, Essential Thrombocythemia
Safety and Efficacy of Momelotinib in Subjects With Polycythemia Vera or Essential Thrombocythemia
This open-label study is to determine the safety and efficacy of momelotinib in participants with either polycythemia vera (PV) or essential thrombocythemia (ET) who have not yet received treatment with a Janus kinase (JAK)…
- Trial name
- NCT01998828
- Testing
- Momelotinib
- Where
- 15 sites in United States, Australia and 3 more
- Volunteers
- 39 people
- Sponsor
- Sierra Oncology LLC - a GSK company
Hemophilia A
Russian Kogenate Pediatric Study
A prospective study to evaluate the effect of rFVIII-FS in different prophylactic regimens on bleeding events frequency and development of arthropathy in Previously Treated and Minimally treated Hemophilia A pediatric population.
- Trial name
- NCT00632814
- Testing
- rFVIII-FS (Kogenate FS, BAY14-2222) 70 IU/kg, dosing once per week, rFVIII-FS (Kogenate FS, BAY14-2222), 70 IU/kg twice per week (30 IU/kg + 40 IU/kg), rFVIII-FS (Kogenate FS, BAY14-2222) 75 IU/kg, dosing three times per week (3 x 25 IU/kg)
- Where
- 4 sites in Russia
- Volunteers
- 32 people
- Sponsor
- Bayer
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