Clinical trials: Acute Coagulopathy
Congenital Bleeding Disorder, Haemophilia A
Haemophilia Patients With Inhibitors Being Treated for Acute Joint Bleeds
This trial is conducted in Africa, Asia, Europe, Japan, and North and South America. The aim of this trial is to evaluate the safety and efficacy of activated recombinant human factor VII analogue (vatreptocog alfa (activated))…
- Conditions
- Congenital Bleeding Disorder, Haemophilia A, Haemophilia B
- Trial name
- NCT00486278
- Testing
- eptacog alfa (activated), vatreptacog alfa (activated)
- Where
- 45 sites in United States, Argentina and 16 more
- Volunteers
- 51 people
- Sponsor
- Novo Nordisk A/S
Thrombocytopaenia
A Rollover Study to Provide Continued Treatment With Eltrombopag
The objective of this study was to provide continued treatment with eltrombopag for subjects who were participating in a Novartis-sponsored investigational study with eltrombopag (parent studies 114968/ASPIRE (NCT01440374)…
- Trial name
- NCT01957176
- Testing
- Eltrombopag (ELT)
- Where
- 13 sites in Belgium, China and 10 more
- Volunteers
- 22 people
- Sponsor
- Novartis Pharmaceuticals
Afibrinogenemia, Hypofibrinogenemia
Fibrinogen Concentrate (Human) - Efficacy and Safety Study
This is a multinational, multicenter, prospective, open-label historically controlled Phase IIIb non-inferiority clinical trial on the efficacy and safety of Fibrinogen Concentrate (Human).
- Conditions
- Afibrinogenemia, Hypofibrinogenemia, Fibrinogen Deficiency
- Trial name
- NCT00916656
- Testing
- Fibrinogen Concentrate, Human (FCH), Cryoprecipitate
- Sponsor
- CSL Behring
Congenital Bleeding Disorder, Haemophilia A With Inhibitors
Efficacy and Safety of NNC 0078-0000-0007 in Patients With Congenital Haemophilia and Inhibitors
This trial is conducted globally. The purpose of this trial is to confirm the efficacy and safety of NNC 0078-0000-0007 in patients with congenital haemophilia and inhibitors.
- Conditions
- Congenital Bleeding Disorder, Haemophilia A With Inhibitors, Haemophilia B With Inhibitors
- Trial name
- adept™2 (NCT01392547)
- Testing
- vatreptacog alfa (activated), eptacog alfa (activated)
- Where
- 32 sites in United States, Austria and 17 more
- Volunteers
- 72 people
- Sponsor
- Novo Nordisk A/S
Acute Myelocytic Leukemia, Acute Lymphocytic Leukemia
Safety and Efficacy of 72-hour and 120-hour Infusion of Rigosertib in Acute Myeloid Leukemia (AML) and Acute Lymphoid Leukemia (ALL)
For patients with leukemia who have not responded to or have progressed after an initial response to standard therapy, therapeutic options are limited.
- Conditions
- Acute Myelocytic Leukemia, Acute Lymphocytic Leukemia, Myeloproliferative Disease, Chronic Myeloid Leukemia
- Trial name
- NCT01167166
- Testing
- rigosertib
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Traws Pharma, Inc.
Acquired Bleeding Disorder, Intracerebral Haemorrhage
Factor VIIa in Acute Intracerebral Haemorrhage
This trial is conducted in Japan. The purpose of this trial is to evaluate the safety and preliminary efficacy of Activated Recombinant Factor VII (NN-007) in patients with acute intracerebral haemorrhage.
- Trial name
- NCT00266006
- Testing
- eptacog alfa (activated)
- Where
- Japan
- Volunteers
- 90 people
- Sponsor
- Novo Nordisk A/S
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
Hemophilia A, Hemophilia B
Recombinant Factor VIIa BI (rFVIIa BI) Treatment of Acute Bleeding Episodes Per an On-demand Regimen
The purpose of the study is to determine the efficacy and safety of rFVIIa BI as part of a six-month on-demand treatment regimen in hemophilia A or B subjects with inhibitors.
- Trial name
- NCT01757405
- Testing
- Recombinant Factor VIIa BI (rFVIIa BI)
- Where
- 16 sites in United States, Japan and 7 more
- Volunteers
- 40 people
- Sponsor
- Baxalta now part of Shire
Acquired Bleeding Disorder, Intracerebral Haemorrhage
Safety and Preliminary Efficacy of Activated Recombinant Human Factor VII in Acute Intracerebral Haemorrhage
This trial is conducted in Asia, Europe and Oceania. The aim of this trial is to evaluate the safety and preliminary efficacy of activated recombinant human factor VII (NovoSeven®) in preventing early haematoma growth in acute…
- Trial name
- NCT01566786
- Testing
- activated recombinant human factor VII
- Where
- 9 sites in Australia, Denmark and 7 more
- Volunteers
- 48 people
- Sponsor
- Novo Nordisk A/S
Coagulation Protein Disorders, Blood Loss, Surgical
Observational Study of Prophylaxis and Treatment of Acute Perioperative Bleeding With Beriplex® P/N (Probe Study)
Beriplex® P/N is made from human plasma (the liquid part of the blood) and contains the coagulation factors II, VII, IX and X which are important for blood clotting (coagulation).
- Conditions
- Coagulation Protein Disorders, Blood Loss, Surgical, Perioperative Care
- Trial name
- NCT01053169
- Testing
- Beriplex® P/N, Fresh Frozen Plasma (FFP) and Beriplex® P/N, Fresh Frozen Plasma
- Where
- 6 sites in United Kingdom
- Volunteers
- 445 people
- Sponsor
- CSL Behring
Purpura, Thrombocytopenic, Idiopathic, Acute Idiopathic Thrombocytopenic Purpura
Subject Variability in Two Lots of E5501 Administered to Fed and Fasted Healthy Subjects
This will be a randomized, open-label, four-group, two-period, replicate design study to evaluate the effect of food on within and between subject variability in second generation formulation 20-mg tablet strengths, Lots…
- Conditions
- Purpura, Thrombocytopenic, Idiopathic, Acute Idiopathic Thrombocytopenic Purpura, Chronic Thrombocytopenia
- Trial name
- NCT01327872
- Testing
- E5501 40 mg 2 x 20-mg tablets, orally, fasted, E5501 40 mg 2 x 20-mg tablets, orally, with food, E5501 40mg 2 x 20-mg tablets, orally, fasted
- Where
- Netherlands
- Volunteers
- 84 people, healthy volunteers welcome
- Sponsor
- Eisai Inc.
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
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.
Acquired Bleeding Disorder, Intracerebral Haemorrhage
Recombinant Factor VIIa in Acute Intracerebral Haemorrhage
This trial is conducted in North America, Europe, Asia and Oceania. The purpose of this study is to evaluate safety and efficacy of Recombinant Factor VIIa in patients with acute intracerebral bleeding.
- Trial name
- NCT00426803
- Testing
- activated recombinant human factor VII
- Where
- 15 sites in Australia, Austria and 13 more
- Volunteers
- 400 people
- Sponsor
- Novo Nordisk A/S
Acquired Bleeding Disorder, Intracerebral Haemorrhage
Safety and Preliminary Efficacy of Activated Recombinant Human Factor VII for Preventing Early Hematoma Growth in Acute Intracerebral Haemorrhage
This trial is conducted in the United States of America (USA). The aim of this trial is to evaluate the safety and preliminary efficacy of activated recombinant human factor VII (NovoSeven®) for preventing early hematoma growth…
- Trial name
- NCT01563445
- Testing
- activated recombinant human factor VII
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Novo Nordisk A/S
Disseminated Intravascular Coagulation (DIC)
A Phase 3 Clinical Study of KW-3357 in Patients With DIC
To evaluate the efficacy and safety of KW-3357 with concomitant use of heparin using multi-center, non-comparative, open-label method in patients diagnosed as disseminated intravascular coagulation (DIC) by Japanese Association…
- Trial name
- 3357-006 (NCT01384409)
- Testing
- KW-3357
- Where
- Japan
- Volunteers
- 5 people
- Sponsor
- Kyowa Kirin Co., Ltd.
Polycythemia Vera, Essential Thrombocythemia
A Study of GLB-001 in Patients With Myeloid Malignancies
Study GLB-001-02 is a phase 1, open-label clinical study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and preliminary efficacy of GLB-001 in study participants with relapsed or refractory or…
- Conditions
- Polycythemia Vera, Essential Thrombocythemia, Myelofibrosis, Myelodysplastic Syndromes
- Trial name
- NCT06378437
- Testing
- GLB-001
- Where
- 14 sites in China
- Volunteers
- 108 people
- Sponsor
- Hangzhou GluBio Pharmaceutical Co., Ltd.
Cancer
Fentanyl Sublingual Spray in Treating Patients With Breakthrough Cancer Pain
This is a phase III, randomized, double-blind, placebo-controlled, multicenter study of the clinical response to fentanyl sublingual spray as a treatment for breakthrough cancer pain.
- Trial name
- NCT00538850
- Testing
- Fentanyl sublingual spray
- Where
- United States
- Volunteers
- 130 people
- Sponsor
- INSYS Therapeutics Inc
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
Acute Heart Failure
Study of Safety, Tolerability and Pharmacokinetics of Serelaxin in Japanese Acute Heart Failure (AHF) Patients
This is a multicenter, randomized, double-blind, placebo-controlled study to assess safety, tolerability and pharmacokinetics and to explore efficacy of IV infusion of 10 µg/kg/day and 30 µg/kg/day serelaxin for 48 hours compared…
- Trial name
- NCT02002702
- Testing
- Serelaxin
- Where
- 15 sites in Japan
- Volunteers
- 46 people
- Sponsor
- Novartis Pharmaceuticals