Clinical trials: Bleeding Diathesis
Hemophilia A
Dose-Response Study of Recombinant Factor VIII Manufactured Protein-Free (rAHF-PFM) in Patients With Hemophilia A
The purpose of this study is to determine the effect of 3 doses of ADVATE rAHF-PFM on initial recovery (% increase [IU/dL] per IU/kg infused) and major single-infusion pharmacokinetic parameters.
- Trial name
- NCT00289536
- Testing
- Antihemophilic factor, recombinant, manufactured protein-free
- Where
- 8 sites in United States
- Volunteers
- 38 people
- Sponsor
- Baxalta now part of Shire
Hematologic Disease, Hemophilia A
BAY14-2222 Prophylaxis and Joint Function Improvement (Adults)
The purpose of the study is to evaluate the effect of prophylactic treatment on the number of joint bleeds and quality of life in severe hemophilia A subjects compared to on-demand treatment in a one-group two-treatment schedule…
- Trial name
- NCT00586521
- Testing
- Kogenate (BAY14-2222)
- Where
- 11 sites in United States, France and 3 more
- Volunteers
- 20 people
- Sponsor
- Bayer
Idiopathic Thrombocytopenic Purpura
Study of a New Medication for Childhood Chronic Immune Thrombocytopenia (ITP), a Blood Disorder of Low Platelet Counts That Can Lead to Bruising Easily, Bleeding Gums, and/or Bleeding Inside the Body.
The purpose of this study is to investigate the efficacy, safety and tolerability of eltrombopag in children with previously treated chronic immune thrombocytopenia who are between 1 and 17 years of age. This is a 2 part study.
- Trial name
- PETIT2 (NCT01520909)
- Testing
- Eltrombopag
- Where
- 51 sites in United States, Argentina and 11 more
- Volunteers
- 92 people
- Sponsor
- GlaxoSmithKline
AIHA - Warm Autoimmune Hemolytic Anemia, AIHA - Cold Autoimmune Hemolytic Anemia
OM336 in Autoimmune Cytopenias
An early-phase clinical trial evaluating the safety, tolerability, and pharmacokinetics of subcutaneously dosed OM336 in adult participants with autoimmune cytopenias.
- Conditions
- AIHA - Warm Autoimmune Hemolytic Anemia, AIHA - Cold Autoimmune Hemolytic Anemia, ITP - Immune Thrombocytopenia
- Trial name
- NCT07083960
- Testing
- OM336
- Where
- 7 sites in United States, Australia
- Volunteers
- 32 people
- Sponsor
- Lakefront Biotherapeutics West LLC
Immune (Idiopathic) Thrombocytopenic Purpura
Clinical Trial in Patients Diagnosed With Immune Thrombocytopenic Purpura
The purpose of this study is to determine whether IGIV3I Grifols 10% is effective in the treatment of immune thrombocytopenic purpura.
- Trial name
- ITP (NCT00699140)
- Testing
- IGIV3I Grifols
- Where
- 7 sites in Russia, Spain and 1 more
- Volunteers
- 18 people
- Sponsor
- Instituto Grifols, S.A.
Immune Thrombocytopenia
A Study of Rilzabrutinib in Adult Patients With Immune Thrombocytopenia (ITP)
This was a 2 part (Part A and B) adaptive, open-label, dose-finding study of PRN1008 in patients with ITP who are refractory or relapsed with no available and approved therapeutic options, with a platelet count <30,000/μL on two…
- Trial name
- NCT03395210
- Testing
- Rilzabrutinib
- Where
- 31 sites in United States, Australia and 6 more
- Volunteers
- 86 people
- Sponsor
- Principia Biopharma, a Sanofi Company
Immune Thrombocytopenia
A Clinical Study to Evaluate the Efficacy and Safety of LIV-GAMMA SN Inj. in Primary Immune Thrombocytopenia (ITP)
The main purpose of this study is to assess the efficacy and safety of LIV-GAMMA SN Inj. in adult subjects with ITP. The primary objective of this study is to determine the responder rate.
- Trial name
- NCT03164915
- Testing
- LIV-GAMMA SN Inj.
- Where
- 6 sites in South Korea
- Volunteers
- 37 people
- Sponsor
- SK Plasma Co., Ltd.
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
Hemophilia A, Healthy Adult Participants
A First-in Human Study of ARD001 in Healthy Volunteers and People With Hemophilia A
This study is evaluating ARD001, an investigational medicine being developed for the treatment of hemophilia A. In Phase 1, healthy adult participants will receive a single dose of ARD001 or placebo to assess its safety and…
- Trial name
- NCT07787091
- Testing
- ARD001
- Where
- Singapore
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Arditus Pte Ltd
Congenital Bleeding Disorder, Haemophilia A
Efficacy and Safety of Turoctocog Alfa for Prophylaxis and Treatment of Bleeding Episodes in Previously Treated Chinese Patients With Haemophilia A
This trial is conducted in China. The aim of this trial is to evaluate the clinical efficacy of turoctocog alfa in treatment of bleeding episodes in Chinese patients with severe haemophilia A (FVIII≤1%).
- Trial name
- guardian TM 7 (NCT02938585)
- Testing
- turoctocog alfa
- Where
- 11 sites in China
- Volunteers
- 68 people
- Sponsor
- Novo Nordisk A/S
Hemophilia B
Recombinant Fusion Protein Linking Coagulation Factor IX With Albumin (rIX-FP) in Chinese Subjects With Hemophilia B Previously Treated With FIX Therapy
This study will investigate the pharmacokinetics (PK), efficacy, and safety of rIX-FP for the routine prophylaxis of bleeding episodes in male Chinese previously treated patients (PTPs) with hemophilia B (FIX activity of ≤ 2%).
- Trial name
- NCT06399289
- Testing
- Recombinant fusion protein linking coagulation factor IX with albumin (rIX-FP)
- Where
- 7 sites in China
- Volunteers
- 23 people
- Sponsor
- CSL Behring
Snake Bite, Blood Coagulation Disorders
A Comparison of Crotalinae Equine Immune F(ab)2 Antivenom (Anavip) and Crotalidae Polyvalent Immune Fab,
This phase II study was a prospective, randomized, open-label, multi-center study in the United States, involving patients from 18 to 70 years of age, comparing Anavip (Antivenin Crotalinae [pit viper] equine immune F(ab)2…
- Trial name
- NCT00868309
- Testing
- Anavip, CroFab
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Instituto Bioclon S.A. de C.V.
Hemophilia A With Inhibitor, Hemophilia B With Inhibitor
Prospective, Non-interventional Study to Evaluate Immunogenicity of AryoSeven
This study evaluates the immunogenicity of the biosimilar rFVIIa (AryoSeven) in subjects receiving AryoSeven in real-life clinical practice.
- Conditions
- Hemophilia A With Inhibitor, Hemophilia B With Inhibitor, Factor VII Deficiency, Glanzmann's Thrombasthenia
- Trial name
- NCT03372993
- Where
- 2 sites in Iran
- Volunteers
- 200 people
- Sponsor
- AryoGen Pharmed Co.
Sepsis, Coagulopathy
A Study to Learn About How Safe BAY 3389934 is, Its Suitable Dose, and How it Affects the Participants With Sepsis Induced Coagulopathy
Researchers are looking for a better way to treat people who have sepsis induced coagulopathy. Sepsis happens when bacteria and their toxins spread in the blood, causing an infection.
- Trial name
- NCT06854640
- Testing
- BAY3389934
- Where
- 21 sites in United States, Belgium and 3 more
- Volunteers
- 36 people
- Sponsor
- Bayer
Hemophilia A
Pharmacokinetic Assessment of Standard Half-Life (SHL) FVIII, Extended Half-Life (EHL) FVIII, and Efanesoctocog Alfa (BIVV001) in Severe Hemophilia A
Primary objective To assess the half-life of BIVV001, Standard Half-Life (SHL) rFVIII and Extended Half-Life (EHL) rFVIII after a single intravenous (IV) injection Secondary objectives To characterize additional pharmacokinetic…
- Trial name
- NCT05042440
- Testing
- Efanesoctocog alfa, Octocog alfa, Rurioctocog alfa pegol
- Where
- Bulgaria
- Volunteers
- 13 people
- Sponsor
- Sanofi
Myelofibrosis, Myelodysplastic Syndrome
Safety and Tolerability Study of INCB057643 in Participants With Myelofibrosis and Other Advanced Myeloid Neoplasms
The purpose of this study is to evaluate the safety, tolerability, and preliminary efficacy of INCB057643 as monotherapy or combination with ruxolitinib for participants with myelofibrosis (MF) and other myeloid neoplasms.
- Conditions
- Myelofibrosis, Myelodysplastic Syndrome, Myelodysplastic/Myeloproliferative Neoplasm Overlap Syndrome, Myeloproliferative Neoplasm
- Trial name
- LIMBER (NCT04279847)
- Testing
- INCB057643, Ruxolitinib
- Where
- 48 sites in United States, Canada and 6 more
- Volunteers
- 140 people
- Sponsor
- Incyte Corporation
Acquired Bleeding Disorder, Cardiac Surgery Requiring Cardiopulmonary Bypass
Safety of Recombinant Factor XIII (rFXIII) in Healthy Japanese Volunteers
This trial is conducted in Japan. The aim of this trial is to investigate the safety profile of recombinant factor XIII (rFXIII) assessed by the occurrence of adverse events in healthy Japanese subjects.
- Conditions
- Acquired Bleeding Disorder, Cardiac Surgery Requiring Cardiopulmonary Bypass, Healthy
- Trial name
- NCT01153997
- Testing
- catridecacog
- Where
- Japan
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Novo Nordisk A/S
Immune Thrombocytopenia (ITP)
A Study of Pirtobrutinib in Participants With Immune Thrombocytopenia
The purpose of the phase 1 part of this study was to evaluate how well pirtobrutinib is tolerated and what side effects may occur.
- Trial name
- NCT06721013
- Testing
- Pirtobrutinib
- Where
- 43 sites in United States, China and 8 more
- Volunteers
- 68 people
- Sponsor
- Eli Lilly and Company
Severe Hemophilia A
Pharmacokinetics and Safety of rFVIIIFc Manufactured at 15,000 L (15K) Scale
The primary objective of the study is to compare the pharmacokinetic (PK) of recombinant coagulation factor VIII Fc fusion protein (rFVIIIFc) manufactured at the current scale of 2000 L (2K) to the PK of rFVIIIFc manufactured at…
- Trial name
- Elevate (NCT02502149)
- Testing
- rFVIIIFc
- Where
- 15 sites in United States, Australia and 1 more
- Volunteers
- 24 people
- Sponsor
- Bioverativ Therapeutics Inc.
Severe Hemophilia A
Study to Evaluate the Safety, Pharmacokinetics and Efficacy of Recombinant Factor VIII Fc Fusion Protein (rFVIIIFc) in Previously Treated Subjects With Severe Hemophilia A
The primary objectives of this study are: to evaluate the safety and tolerability of rFVIIIFc administered as a prophylaxis (Arm 1), weekly (Arm 2), on-demand (Arm 3), and surgical treatment regimen; to evaluate the efficacy of…
- Trial name
- NCT01181128
- Testing
- Factor VIII (rFVIIIFc), Advate®
- Where
- 64 sites in United States, Australia and 17 more
- Volunteers
- 165 people
- Sponsor
- Bioverativ Therapeutics Inc.