Clinical trials: Bleeding Diathesis
Congenital Bleeding Disorder, Congenital FXIII Deficiency
Safety and Pharmacokinetics of Recombinant Factor XIII Administration in Healthy Volunteers
This trial was conducted in Europe. The aim of this trial was to investigate safety and pharmacokinetics of multiple doses of catridecacog (recombinant factor XIII, rFXIII) in healthy volunteers.
- Conditions
- Congenital Bleeding Disorder, Congenital FXIII Deficiency, Healthy
- Trial name
- NCT01848002
- Testing
- catridecacog
- Where
- United Kingdom
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Novo Nordisk A/S
Immune Thrombocytopenia
Safety and Efficacy of GL-2045 in Patients With Immune Thrombocytopenia
The goal of this clinical trial is to demonstrate GL-2045 safety and efficacy proof of concept by demonstrating intravenous immunoglobulin (IVig)-like platelet responses in adult patients with Immune Thrombocytopenia (ITP).
- Trial name
- NCT07605845
- Testing
- GL-2045
- Where
- United Kingdom
- Volunteers
- 42 people
- Sponsor
- Gliknik Inc.
Idiopathic Pulmonary Fibrosis
23andMe IPF Research Study
The long term goal of this study is to increase genetic understanding of IPF to enable the development of an effective drug for IPF that can improve the lives of those living with the condition.
- Trial name
- IPF (NCT05028894)
- Testing
- No intervention
- Where
- United States
- Volunteers
- 690 people
- Sponsor
- 23andMe, Inc.
Coagulopathy, Endstage Liver Disease
Evaluation of the Safety of Octaplas™ Versus Plasma in Patients Undergoing Orthotopic Liver Transplantation
Post-Marketing Requirement study to evaluate the safety of octaplas™ versus plasma in patients undergoing orthotopic liver transplantation (OLT).
- Trial name
- NCT02037373
- Testing
- Octaplas™, Plasma
- Where
- 4 sites in United States
- Volunteers
- 43 people
- Sponsor
- Octapharma
Hemophilia A
Study Evaluating Safety Of Patients Switching To ReFacto AF In Usual Care Settings
The study will be investigating safety in patients who switch to ReFacto AF from ReFacto and other Factor VIII products.
- Trial name
- NCT00884390
- Testing
- moroctocog alfa (AF-CC) (ReFacto AF), Laboratory tests
- Where
- 74 sites in Austria, Belgium and 12 more
- Volunteers
- 208 people
- Sponsor
- Pfizer
Congenital Afibrinogenemia, Hypofibrinogenemia
FIB Grifols Congenital Deficiency for On-demand Treatment and Surgical Prophylaxis
This is a phase 3, multi-center, prospective, open-label, single-arm, clinical trial to be carried out in subjects with congenital fibrinogen deficiency manifested as afibrinogenemia or severe hypofibrinogenemia.
- Trial name
- NCT04636268
- Testing
- FIB Grifols
- Sponsor
- Instituto Grifols, S.A.
Congenital Afibrinogenemia, Congenital Hypofibrinogenemia
Pharmacokinetic, Efficacy and Safety of BT524 in Patients With Congenital Fibrinogen Deficiency
This was a prospective, open-label, multicenter, phase I/III study investigating the 14-day single-dose pharmacokinetic and pharmacodynamic properties, efficacy and safety of BT524 following intravenous administration in the…
- Trial name
- NCT02065882
- Testing
- BT524 (Part I), BT524 (Part II)
- Where
- 6 sites in Bulgaria, Egypt and 3 more
- Volunteers
- 67 people
- Sponsor
- Biotest
Adeno-Associated Virus (AAV), Blood Coagulation Disorder
Dose-finding Study of SPK-8016 Gene Therapy in Patients With Hemophilia A to Support Evaluation in Individuals With FVIII Inhibitors
SPK-8016 is in development for the treatment of patients with inhibitors to FVIII. This Phase 1/2, open-label, non-randomized, dose-finding study to evaluate the safety, efficacy, and tolerability of SPK-8016 in adult males with…
- Conditions
- Adeno-Associated Virus (AAV), Blood Coagulation Disorder, Blood Coagulation Disorders, Inherited, Coagulation Protein Disorders
- Trial name
- NCT03734588
- Testing
- SPK-8016
- Where
- 11 sites in United States
- Volunteers
- 4 people
- Sponsor
- Spark Therapeutics, Inc.
Congenital Bleeding Disorder, Haemophilia A With Inhibitors
Safety and Efficacy of Activated Recombinant Human Factor VII in Haemophilia Patients With Inhibitors During and After Major Surgery
This trial is conducted in North America. The aim of this trial is to compare the safety and efficacy of activated recombinant human factor VII in patients with haemophilia A or B undergoing major surgical procedures.
- Conditions
- Congenital Bleeding Disorder, Haemophilia A With Inhibitors, Haemophilia B With Inhibitors
- Trial name
- NCT01561391
- Testing
- activated recombinant human factor VII, factor IX, factor VIII
- Where
- 14 sites in United States
- Volunteers
- 36 people
- Sponsor
- Novo Nordisk A/S
Antiphospholipid Syndrome (APS), Bullous Pemphigoid (BP)
Phase 1b Trial of RAY121 in Immunological Diseases (RAINBOW Trial)
This Phase 1b basket trial will investigate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity and preliminary efficacy of RAY121, a inhibitor of classical complement pathway, after multiple dose…
- Conditions
- Antiphospholipid Syndrome (APS), Bullous Pemphigoid (BP), Behçet's Syndrome (BS), Dermatomyositis (DM)
- Trial name
- NCT06371417
- Testing
- RAY121
- Where
- 77 sites in United States, Australia and 18 more
- Volunteers
- 144 people
- Sponsor
- Chugai Pharmaceutical
Hemophilia A
Efficacy and Safety of Recombinant Factor VIII (GreenGene) in Patients With Hemophilia A
The purpose of this study is to study the evaluation of efficacy and safety of GreenGene (Recombinant Factor VIII).
- Trial name
- NCT01568580
- Testing
- GreenGene
- Volunteers
- 71 people
- Sponsor
- Green Cross Corporation
Hemophilia A
Quality of Life Study of Helixate NexGen
The aim of this study is to describe Health Related Quality of Life (HRQoL) in adolescents and adults with Hemophilia A treated prophylactically or on-demand with Helixate NexGen.
- Trial name
- NCT01053715
- Where
- 31 sites in Austria, Belgium and 5 more
- Volunteers
- 78 people
- Sponsor
- CSL Behring
Chemotherapy-induced Thrombocytopenia, Immune Thrombocytopenic Purpura
A Study of PN20 in Healthy Adult Volunteers
The main aim of this clinical trial is to assess the safety of PN20 in healthy volunteers aged 18 to 50 years. The main questions it aims to answer are: Is PN20 safe in adult? Researchers will compare PN20 to a placebo (a…
- Trial name
- NCT06523088
- Testing
- PN20
- Where
- China
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- Chongqing Peg-Bio Biopharm Co., Ltd.
Systemic Lupus Erythematosus (SLE), Idiopathic Inflammatory Myopathy (IIM)
Safety Study of CC312 in Autoimmune Disease Patients
This study is an open-label, multiple-dose escalation, Investigator-Initiated Trial (IIT) clinical trial designed to evaluate the safety and tolerability of CC312 in adult patients with relapsed and refractory autoimmune…
- Conditions
- Systemic Lupus Erythematosus (SLE), Idiopathic Inflammatory Myopathy (IIM), Systemic Sclerosis (SSc), Rheumatoid Arthritis (RA)
- Trial name
- NCT06888960
- Testing
- CC312
- Where
- China
- Volunteers
- 18 people
- Sponsor
- CytoCares Inc
Myeloproliferative Neoplasm
A Study Evaluating Safety and Tolerability, and Pharmacokinetics of Navitoclax Monotherapy and in Combination With Ruxolitinib in Participants With Myeloproliferative Neoplasm
There are 5 parts to this study for which the primary objectives are to evaluate safety, tolerability, and pharmacokinetics (PK) of navitoclax when administered alone (Part 1) or when administered in combination with ruxolitinib…
- Trial name
- NCT04041050
- Testing
- Navitoclax, Ruxolitinib, Celecoxib
- Where
- 42 sites in United States, Belgium and 12 more
- Volunteers
- 85 people
- Sponsor
- AbbVie
Hemophilia A, Prophylaxis of Bleeding
A Study to Learn More About the Safety of Damoctocog-alfa-pegol When Used in Routine Medical Care in Korean Participants With Hemophilia A
In this study, researchers will observe and study the data from participants with hemophilia A who receive damoctocog alfa pegol as prescribed by their doctors.
- Conditions
- Hemophilia A, Prophylaxis of Bleeding, Treatment of Bleeding
- Trial name
- NCT06222697
- Testing
- Damoctocog-alfa-pegol (Jivi, BAY94-9027)
- Where
- South Korea
- Volunteers
- 20 people
- Sponsor
- Bayer
Severe Hemophilia A
Post Approval Phase 4 Study to Learn More About How Safe Octocog Alfa is, and How Well it Works in Patients With Severe Hemophilia A in India
Hemophilia A is a genetic condition that makes it hard for blood to clot properly. This happens because the body does not have enough of a protein called Factor VIII, which helps stop bleeding.
- Trial name
- HEMOCT INDIA (NCT07446010)
- Testing
- Octocog alfa
- Volunteers
- 30 people
- Sponsor
- Bayer
Hypofibrinogenemia, Hemorrhage
Cryo-FIRST: Effectiveness of INTERCEPT Fibrinogen Complex (IFC) for Trauma-Associated Hemorrhage
The objective of this multicenter, single-arm, observational study is to determine the feasibility and effectiveness of early administration of FDA-approved, pre-thawed Pathogen Reduced Cryoprecipitated Fibrinogen Complex…
- Conditions
- Hypofibrinogenemia, Hemorrhage, Trauma Associated Hemorrhage, Hemorrhagic Shock
- Trial name
- CRYO-FIRST (NCT07218185)
- Testing
- Pathogen Reduced Cryoprecipitated Fibrinogen Complex
- Where
- 4 sites in United States
- Volunteers
- 320 people
- Sponsor
- Cerus Corporation
Hemophilia A
Study Evaluating Refacto For Pharmacovigilance
The purpose of this study is to investigate the effectiveness and safety of treatment with ReFacto under conditions of routine therapy. Furthermore a continuous benefit/risk assessment will be done.
- Trial name
- NCT00195442
- Testing
- Moroctocog alfa
- Where
- 26 sites in Austria, Germany
- Volunteers
- 288 people
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Idiopathic Thrombocytopenic Purpura (ITP)
Phase I Safety and Tolerability Study of Staphylococcal Protein A in Adult Patients With Chronic ITP
The primary purpose of this study is to evaluate the safety of multiple doses of Staphylococcal protein A (PRTX-100) in adult patients with Idiopathic Thrombocytopenia Purpura (ITP).
- Trial name
- NCT00571467
- Testing
- PRTX-100 (Staphylococcal protein A)
- Where
- 7 sites in Australia, New Zealand
- Volunteers
- 9 people
- Sponsor
- Protalex, Inc.