Clinical trials: Bleeding Diathesis
Hemophilia A, Severe
A Study Evaluating Physical Activity and Joint Health in Severe Haemophilia A Patients ≥12 Years Treated Once Weekly With Efanesoctocog Alfa
FREEDOM is a multicentre, open-label, single-arm, phase 3b study in Europe that aims to enrol approximately 90 previously treated severe haemophilia A patients aged ≥12 years, currently on prophylaxis.
- Trial name
- FREEDOM (NCT05817812)
- Testing
- Efanesoctocog alfa
- Where
- 30 sites in Austria, Croatia and 12 more
- Volunteers
- 93 people
- Sponsor
- Swedish Orphan Biovitrum
Thrombotic Thrombocytopenic Purpura (TTP)
Safety and Efficacy Study to Compare Uniplas With Cryosupernatant Plasma in Thrombotic Thrombocytopenic Purpura (TTP)
Prior to the use of plasma products, thrombotic thrombocytopenic purpura (TTP) was usually a fatal condition. During plasma exchange therapy, patients need transfusion plasma that is blood group specific.
- Trial name
- NCT00411801
- Testing
- Uniplas, Cryosupernatant plasma
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- Octapharma
Congenital Bleeding Disorder, Haemophilia A With Inhibitors
Non-Interventional Study of NovoSeven® Used as On-demand Treatment of Bleeds in Patients With Haemophilia A and B With Inhibitors
This study is conducted in Japan. The aim of this registry study is to observe the use of single dose and multi-dose use of eptacog alpha (NovoSeven®) and to compare short-term outcomes, including effectiveness, safety, quality…
- Conditions
- Congenital Bleeding Disorder, Haemophilia A With Inhibitors, Haemophilia B With Inhibitors
- Trial name
- NCT01586936
- Testing
- eptacog alfa (activated)
- Where
- Japan
- Volunteers
- 9 people
- Sponsor
- Novo Nordisk A/S
Acute Major Bleeding, Reversal of Coagulopathy
Study of a Prothrombin Complex Concentrate for Rapid Reversal of Coagulopathy Induced by Vitamin K Antagonists in Japanese Subjects
The purpose of this study is to evaluate efficacy and safety of a Prothrombin Complex Concentrate (PCC), BE1116. BE1116 will be used for the rapid reversal of coagulopathy induced by vitamin K antagonists in Japanese subjects who…
- Trial name
- NCT02281201
- Testing
- BE1116 (Prothrombin Complex Concentrate)
- Where
- 11 sites in Japan
- Volunteers
- 11 people
- Sponsor
- CSL Behring
Hemophilia A
Pharmacokinetics and Safety of a Single Intravenous Infusion of BAY 79-4980
The primary objective of this study is to determine the pharmacokinetic profile after single administration of two doses of BAY 79-4980 (high and low: 35 IU FVIII/Kg reconstituted in 22 mg and 13 mg of liposomes/Kg, respectively)…
- Trial name
- NCT00629837
- Testing
- Recomb. Factor VIII (Kogenate FS Liposome, BAY79-4980), Recombinant Factor VIII (Kogenate FS, BAY14-2222)
- Where
- 2 sites in United States
- Volunteers
- 27 people
- Sponsor
- Bayer
Hemophilia A
Safety & Efficacy of Encapsulated Allogeneic FVIII Cell Therapy in Haemophilia A
SIG-001-121 is a first-in-human (FIH), phase 1/2, multi-centre, open-label, dose escalation study to assess the safety, tolerability, and preliminary efficacy of SIG-001 in adults with severe or moderately severe haemophilia A…
- Trial name
- NCT04541628
- Testing
- SIG-001
- Where
- 6 sites in United States, United Kingdom
- Volunteers
- 3 people
- Sponsor
- Eli Lilly and Company
Hemophilia
A Safety and Efficacy Study of STSP-0601 in Adult Patients With Hemophilia A or B With Inhibitor
This study will assess the safety and efficacy of multiple-dose of STSP-0601 for the treatment of bleeding episodes in hemophilia A or B patients with inhibitors.
- Trial name
- NCT05027230
- Testing
- STSP-0601 for Injection
- Where
- China
- Volunteers
- 77 people
- Sponsor
- Staidson (Beijing) Biopharmaceuticals Co., Ltd
Hemophilia A
Long-Term Safety and Efficacy of rFVIIIFc in the Prevention and Treatment of Bleeding Episodes in Previously Treated Participants With Hemophilia A
The primary objective of the study is to evaluate the long-term safety of recombinant human Factor VIII Fc fusion protein (rFVIIIFc) in participants with hemophilia A.
- Trial name
- ASPIRE (NCT01454739)
- Testing
- rFVIIIFc
- Where
- 78 sites in United States, Australia and 20 more
- Volunteers
- 240 people
- Sponsor
- Bioverativ Therapeutics Inc.
Hemophilia A
Efficacy and Safety Study of a Recombinant Protein-Free Manufactured Factor VIII (rAHF-PFM) in Previously Untreated Hemophilia A Patients
The purpose of this study is to evaluate whether Antihemophilic factor, recombinant, manufactured protein-free (rAHF-PFM) is effective and safe in the treatment of hemophilia A patients who have not been treated with factor VIII…
- Trial name
- NCT00157157
- Testing
- Recombinant Antihemophilic Factor Manufactured and Formulated without Added Human or Animal Proteins (rAHF-PFM)
- Where
- 35 sites in United States, Austria and 8 more
- Volunteers
- 66 people
- Sponsor
- Baxalta now part of Shire
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
Von Willebrand Disease
A Study of Recombinant Von Willebrand Factor (rVWF) With or Without ADVATE in Children With Severe Von Willebrand Disease (VWD)
The main aim of the study is to check effectiveness, side effects, and tolerability of vonicog alfa (recombinant von Willebrand factor [rVWF]), with or without ADVATE, in the treatment and control of nonsurgical bleeding events…
- Trial name
- NCT02932618
- Testing
- Vonicog alfa, Antihemophilic Factor (Recombinant)
- Where
- 46 sites in United States, Austria and 11 more
- Volunteers
- 47 people
- Sponsor
- Baxalta now part of Shire
Primary Immune Thrombocytopenia
A Phase 3 Study to Evaluate the Safety and Efficacy of Efgartigimod PH20 Subcutaneous in Adult Patients With Primary Immune Thrombocytopenia
The main aim of the study is to evaluate the safety and efficacy of efgartigimod PH20 SC (subcutaneous) in adult patients with primary immune thrombocytopenia (ITP).
- Trial name
- ADVANCE SC+ (NCT04812925)
- Testing
- efgartigimod PH20 SC
- Where
- 83 sites in United States, Argentina and 23 more
- Volunteers
- 173 people
- Sponsor
- argenx
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
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
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