Clinical trials: Coagulation Defect; Bleeding
Immune Thrombocytopenia
Long-term Study of Romiplostim in Thrombocytopenic Pediatric Patients With Immune Thrombocytopenia (ITP)
This is a phase 3b single arm, open label, multicenter study describing the percentage of time pediatric participants with ITP have a platelet response while receiving romiplostim, defined as a platelet count ≥ 50 x 10^9/L in the…
- Trial name
- NCT02279173
- Testing
- Romiplostim
- Where
- 78 sites in United States, Australia and 15 more
- Volunteers
- 203 people
- Sponsor
- Amgen
Immune Thrombocytopenic Purpura
Higher Dose of Rituxan Versus Standard Doses of Rituxan With Cyclophosphamide, Vincristine, and Prednisone in Subjects With Chronic ITP
This study is designed to compare the efficacy and safety of higher doses of Rituxan with a regimen combining standard doses of Rituxan + CVP in patients with chronic ITP who did not respond to or relapsed after standard doses of…
- Trial name
- NCT00774202
- Testing
- Rituxan, Cyclophosphamide, Vincristine, Prednisone, Higher Dose of Rituximab
- Where
- United States
- Volunteers
- 17 people
- Sponsor
- Weill Medical College of Cornell University
Immune Thrombocytopenia
Eltrombopag and the Bcl-extra-large (xL) Pathway in Idiopathic Thrombocytopenic Purpura (ITP)
The purpose of this study is to further evaluate the effects that eltrombopag (and romiplostim) have on platelets in subjects with chronic ITP.
- Trial name
- NCT00902018
- Testing
- Eltrombopag, Romiplostim, healthy controls
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Weill Medical College of Cornell University
Idiopathic Thrombocytopenic Purpura
A Phase 3, Multicenter, Randomized, Double-blind,Active-controlled, Parallel-group Trial With an Open-labelExtension Phase to Evaluate the Efficacy and Safety of OralE5501 Versus Eltrombopag, in Adults With Chronic ImmuneThrombocytopenia (Idiopathic Thrombocytopenic Purpura)
Core study: To compare the efficacy of avatrombopag (in addition to standard) of care to eltrombopag (in addition to standard of care) for the treatment of adult participants with chronic immune thrombocytopenia (idiopathic…
- Trial name
- NCT01433978
- Testing
- Eltrombopag, Avatrombopag, Standard of care
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- Eisai Inc.
Immune Thrombocytopenia (ITP)
A Study to Assess Efficacy and Safety of Eltrombopag in Combination With a Short Course of Dexamethasone in Patients With Newly Diagnosed ITP
The purpose of this study was to compare the ability of eltrombopag in combination with a short course of high-dose dexamethasone to induce sustained response off treatment in patients with newly-diagnosed ITP versus 1-3 cycles…
- Trial name
- XPAG-ITP (NCT04346654)
- Testing
- Eltrombopag, Dexamethasone
- Where
- 10 sites in Germany
- Volunteers
- 26 people
- Sponsor
- Novartis Pharmaceuticals
Blood Coagulation Disorders, Hemorrhage
Does Plasma Reduce Bleeding in Patients Undergoing Invasive Procedures
The purpose of this study is to evaluate prophylactic fresh frozen plasma transfusion in patients with moderately elevated international normalized ratios (INR) prior to undergoing an invasive procedure.
- Trial name
- NCT02637427
- Testing
- Fresh frozen plasma transfusion
- Where
- 2 sites in United States
- Volunteers
- 57 people
- Sponsor
- Rutgers, The State University of New Jersey
Purpura, Thrombocytopenic, Idiopathic and Hepatitis C
Eltrombopag Phase III Study In Chinese Chronic ITP Patients
This randomized, double-blind and open-label phase III study aimed to determine the efficacy, tolerance and safety of eltrombopag in Chinese chronic primary immune thrombocytopenia (ITP) adult subjects.
- Trial name
- NCT01762761
- Testing
- eltrombopag
- Where
- 18 sites in China
- Volunteers
- 155 people
- Sponsor
- Novartis Pharmaceuticals
Blood Coagulation Disorders, Acute Major Bleeding
Efficacy and Safety Study of BERIPLEX® P/N (Kcentra) Compared With Plasma in Patients With Acute Major Bleeding Caused by Anticoagulant Therapy
The purpose of this study is to evaluate efficacy, safety and tolerance of BERIPLEX® P/N (Kcentra) compared with plasma in regard to rapid reversal of coagulopathy induced by coumarin derivatives in subjects who require immediate…
- Trial name
- NCT00708435
- Testing
- Beriplex® P/N (Kcentra), Fresh frozen plasma
- Where
- 69 sites in United States, Belarus and 4 more
- Volunteers
- 216 people
- Sponsor
- CSL Behring
Immune Thrombocytopenia
Study of Oral SKI-O-703, SYK Inhibitor, in Patients With Persistent and Chronic Immune Thrombocytopenia (ITP)
Study in patients with persistent and chronic Immune Thrombocytopenia (ITP), who have failed to respond or relapsed after prior therapy, with a platelet count <30,000/µL.
- Trial name
- NCT04056195
- Testing
- SKI-O-703
- Where
- 27 sites in United States, Greece and 3 more
- Volunteers
- 61 people
- Sponsor
- Oscotec Inc.
Immune Thrombocytopenic Purpura
Open Label Study of R788 in the Treatment of Persistent/Chronic Immune Thrombocytopenic Purpura (ITP)
The primary objective of this study was to assess the long term safety of fostamatinib in subjects with persistent/chronic ITP
- Trial name
- NCT02077192
- Testing
- Fostamatinib Disodium
- Where
- 55 sites in United States, Australia and 13 more
- Volunteers
- 123 people
- Sponsor
- Rigel Pharmaceuticals
Thrombotic Thrombocytopenic Purpura
Safety Study of Danazol With Plasma Exchange and Steroids for the Treatment of Thrombotic Thrombocytopenic Purpura (TTP)
The purpose of the study is to find out if administration of danazol with plasma exchange and corticosteroids will reduce the number of plasma exchanges required to control Thrombotic Thrombocytopenic Purpura (TTP).
- Trial name
- TTP (NCT00953771)
- Testing
- Danazol
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- Icahn School of Medicine at Mount Sinai
Congenital Bleeding Disorder, Haemophilia B
Efficacy and Safety of NNC-0156-0000-0009 During Surgical Procedures in Subjects With Haemophilia B
This trial is conducted in Africa, Asia, Europe and the United States of America (USA). The aim of the trial is to evaluate the safety and efficacy of NNC-0156-0000-0009 (nonacog beta pegol) during surgical procedures in patients…
- Trial name
- paradigm™ 3 (NCT01386528)
- Testing
- nonacog beta pegol
- Where
- 41 sites in United States, Austria and 15 more
- Volunteers
- 13 people
- Sponsor
- Novo Nordisk A/S
Acquired Thrombotic Thrombocytopenic Purpura
Follow-up Study for Patients Who Completed Study ALX0681-C301 (Post-HERCULES)
The objectives of this study were to evaluate long-term safety and efficacy of caplacizumab, to evaluate safety and efficacy of repeated use of caplacizumab and to characterize long-term impact of acquired thrombotic…
- Trial name
- NCT02878603
- Testing
- Caplacizumab, Standard of Care
- Where
- 45 sites in United States, Austria and 11 more
- Volunteers
- 104 people
- Sponsor
- Sanofi
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
Immune Thrombocytopenic Purpura (ITP)
Safety and Tolerability of M254 in Healthy Volunteers and Immune Thrombocytopenic Purpura (ITP) Patients
The purpose of this study is to assess safety, tolerability, pharmacokinetics, and pharmacodynamics of M254 after administration of a single ascending dose and repeat doses in healthy volunteers and immune thrombocytopenic…
- Trial name
- NCT03866577
- Testing
- Biological: M254, Intravenous immunoglobulin (IVIg)
- Where
- 28 sites in United States, Belgium and 5 more
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Momenta Pharmaceuticals, Inc.
Congenital Bleeding Disorder, Haemophilia A With Inhibitors
A Trial Evaluating the Efficacy and Safety of Prophylactic Administration of Concizumab in Haemophilia A and B Patients With Inhibitors
This trial is conducted in Africa, Asia, Europe and North America. The aim of the trial is to assess the efficacy of concizumab administered s.c.
- Conditions
- Congenital Bleeding Disorder, Haemophilia A With Inhibitors, Haemophilia B With Inhibitors
- Trial name
- explorer™4 (NCT03196284)
- Testing
- Concizumab, Eptacog alfa
- Where
- 22 sites in United States, Austria and 12 more
- Volunteers
- 26 people
- Sponsor
- Novo Nordisk A/S
Thrombocytopenia, Idiopathic Thrombocytopenic Purpura
Study on Bone Marrow Morphology in Adults Receiving Romiplostim for Treatment of Thrombocytopenia Associated With Immune Thrombocytopenia Purpura (ITP)
The purpose of this study is to evaluate changes in bone marrow morphology (structure) after long-term exposure to romiplostim.
- Trial name
- NCT00907478
- Testing
- romiplostim
- Volunteers
- 169 people
- Sponsor
- Amgen
Hemophilia B
Dose Confirmation Trial of AAV5-hFIXco-Padua
This is an open-label, single-dose, single-arm, multi-center trial, with a screening, a treatment + post-treatment follow-up phase, and a long-term follow-up phase.
- Trial name
- NCT03489291
- Testing
- AAV5-hFIXco-Padua (AMT-061)
- Where
- 4 sites in United States
- Volunteers
- 3 people
- Sponsor
- CSL Behring
Immune Thrombocytopenia
Safety and Treatment Satisfaction in Adults With Chronic ITP After Switching to Avatrombopag From Eltrombopag or Romiplostim
Evaluate the safety and tolerability of avatrombopag given for 90 days after stopping treatment with eltrombopag or romiplostim.
- Trial name
- NCT04638829
- Testing
- Avatrombopag Oral Tablet
- Where
- 20 sites in United States
- Volunteers
- 60 people
- Sponsor
- Sobi, Inc.
Immune Thrombocytopenia
Eltrombopag vs Standard Front Line Management for Newly Diagnosed Immune Thrombocytopenia (ITP) in Children
This is an investigator initiated, multicenter, open label, randomized phase 3 study for subjects with newly diagnosed ITP from ages 1 to less than 18 years old.
- Trial name
- NCT03939637
- Testing
- Eltrombopag, Steroids, IVIG
- Where
- 27 sites in United States
- Volunteers
- 122 people
- Sponsor
- Baylor College of Medicine