Clinical trials: Disorders, Blood Coagulation
Bioequivalence Study in Healthy Subjects, Immune Thrombocytopenia (ITP)
Bioequivalence Study of SKI-O-703 in Healthy Adults Under Fed Conditions
This is an open-label, randomized, crossover Phase 1 study to evaluate the bioequivalence, pharmacokinetics, and safety of two oral SKI-O-703 drugs (test and reference) in healthy adults under fed conditions.
- Conditions
- Bioequivalence Study in Healthy Subjects, Immune Thrombocytopenia (ITP), Rheumatoid Arthritis (RA)
- Trial name
- NCT07675226
- Testing
- SKI-O-703 API in Capsules, SKI-O-703 Formulated Granules in Capsules
- Where
- South Korea
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Oscotec Inc.
Von Willebrand Disease
Study of Voncento® in Subjects With Von Willebrand Disease
This is a multi-centre, open-label, single-arm, phase 4, post-marketing study to further investigate the efficacy and safety of Voncento in subjects with Von Willebrand Disease (VWD) in whom treatment with a Von Willebrand Factor…
- Trial name
- NCT02552576
- Testing
- Voncento
- Where
- 12 sites in Austria, Germany and 3 more
- Volunteers
- 26 people
- Sponsor
- CSL Behring
Hemophilia A
BAX 855 Continuation
To continue the evaluation of the safety and efficacy of BAX 855 for prophylaxis and treatment of bleeding episodes in adult and pediatric previously treated patients (PTPs) aged ≤ 75 years of age with severe hemophilia A.
- Trial name
- NCT01945593
- Testing
- BAX855
- Where
- 89 sites in United States, Australia and 21 more
- Volunteers
- 218 people
- Sponsor
- Baxalta now part of Shire
Essential Thrombocythaemia
Anagrelide vs. Hydroxyurea - Efficacy and Tolerability Study in Patients With Essential Thrombocythaemia
Study AOP 03-007 was designed as a pivotal study to test, if Anagrelide (Thromboreductin®)was not inferior to HU with respect to efficacy in patients with ET.
- Trial name
- ANAHYDRET (NCT01065038)
- Testing
- Anagrelide, Hydroxyurea
- Where
- 24 sites in Austria, Czechia and 8 more
- Sponsor
- AOP Orphan Pharmaceuticals AG
Congenital Bleeding Disorder, Haemophilia A
Safety and Efficacy of Turoctocog Alfa (N8) in Prevention and On-demand Treatment of Bleeding Episodes in Subjects With Haemophilia A: An Extension to Trials NN7008-3543, NN7008-3545, NN7008-3600, NN7008-3893 and NN7008-4015
This trial is conducted in Asia, Europe, Japan, Oceania, North America and South America. The aim of the trial is to investigate the safety and efficacy of turoctocog alfa (N8) in Haemophilia A patients.
- Trial name
- NCT00984126
- Testing
- turoctocog alfa
- Where
- 57 sites in United States, Brazil and 18 more
- Volunteers
- 214 people
- Sponsor
- Novo Nordisk A/S
Wound; Rupture, Surgery, Cesarean Section, Postpartum Hemorrhage
HEMOLEVEN® Expanded Access Program Prevention of Surgical/Postpartum Hemorrhage Severe Inherited Factor XI Deficiency
The objective of the Expanded Access Program is to provide HEMOLEVEN, a replacement coagulation factor XI, to patients with severe inherited factor XI deficiency where, in the opinion of the treating physician, the benefits of…
- Conditions
- Wound; Rupture, Surgery, Cesarean Section, Postpartum Hemorrhage, Surgery
- Trial name
- EAP (NCT01701947)
- Testing
- Hemoleven
- Where
- United States
- Sponsor
- Laboratoire français de Fractionnement et de Biotechnologies
Obesity, Adiposity
Endoscopic Gastric Mucosal Ablation as a Primary Obesity Therapy
This study is intended to investigate safety and feasibility of a new weight loss technique called endoscopic Gastric Mucosal Ablation (GMA) that does not require surgery, but can be achieved using an endoscopic procedure.
- Trial name
- COMET (NCT05486338)
- Testing
- Hybrid Argon Plasma Coagulation (HAPC)
- Where
- 2 sites in United States
- Volunteers
- 15 people
- Sponsor
- Erbe Elektromedizin GmbH
Hereditary Hemorrhagic Telangiectasia (HHT), Osler Weber Rendu Disease
Harmony-HHT: ATV-1601 in Participants With Hereditary Hemorrhagic Telangiectasia (HHT)
This is a 2-part study evaluating ATV-1601 in participants with moderate to severe HHT. Part 1 is a randomized, double-blind, placebo-controlled study evaluating 3 dosing regimens of ATV-1601.
- Trial name
- NCT07601425
- Testing
- ATV-1601
- Where
- 8 sites in United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Atavistik Bio, Inc
Chronic Immune Thrombocytopenia, Primary Immune Thrombocytopenia
Cognitive Status, Fatigue and Inflammation in Patients With Immune Thrombocytopenia (ITP)
This is a multi-center, hospital based, cross-sectional study based on data from patient medical records, including laboratory results.
- Conditions
- Chronic Immune Thrombocytopenia, Primary Immune Thrombocytopenia, Adult Immune Thrombocytopenia
- Trial name
- NCT06665308
- Testing
- No intervention
- Where
- 4 sites in United States, United Kingdom
- Volunteers
- 97 people
- Sponsor
- Sanofi
Hemophilia A
A Trial to Compare Prophylaxis Therapy to On-demand Therapy With a New Full Length Recombinant FVIII in Patients With Severe Hemophilia A
The objective of the trial is to demonstrate that 2-3 times per week prophylaxis therapy with BAY81-8973 is superior to on-demand therapy with BAY81-8973 in patients with severe Hemophilia A.
- Trial name
- Leopold II (NCT01233258)
- Testing
- rFVIII (BAY81-8973) on demand, rFVIII (BAY81-8973) prophylaxis low-dose, rFVIII (BAY81-8973) prophylaxis high-dose
- Where
- 47 sites in United States, Argentina and 16 more
- Volunteers
- 80 people
- Sponsor
- Bayer
Immune Thrombocytopenia
A Real World Study of Treatment Patterns and Effectiveness of Standard of Care in Primary Immune Thrombocytopenia Patients
The aim of this study was to describe real-world treatment patterns and standard of care treatment effectiveness and utilization outcomes in adult primary ITP patients indicated for second-line treatment with any prior…
- Trial name
- NCT07805408
- Where
- United States
- Volunteers
- 3,714 people
- Sponsor
- Novartis Pharmaceuticals
Hemophilia A
China ADVATE PTP Study
The purpose of this study is to assess efficacy, safety and pharmacokinetics of ADVATE in the treatment and prevention of bleeding episodes (BEs)
- Trial name
- NCT02170402
- Testing
- Octocog alfa (recombinant human coagulation factor VIII)
- Where
- 11 sites in China
- Volunteers
- 82 people
- Sponsor
- Baxalta now part of Shire
Hemophilia B
Trial of AAV5-hFIX in Severe or Moderately Severe Hemophilia B
This study evaluates how safe gene therapy treatment with AAV5-hFIX is in adult patients with severe or moderately severe hemophilia B and severe bleeding type.
- Trial name
- NCT02396342
- Testing
- AAV5-hFIX
- Where
- 7 sites in Denmark, Germany and 1 more
- Volunteers
- 10 people
- Sponsor
- CSL Behring
Acquired Bleeding Disorder, Trauma
Efficacy and Safety of Activated Recombinant Human Factor VII in Severely Injured Trauma Patients
This trial is conducted in Africa, Asia, Europe, Oceania and North America. The aim of this trial is to evaluate the efficacy of activated recombinant human factor VII given in conjunction with standard therapy in the treatment…
- Trial name
- NCT01563523
- Testing
- activated recombinant human factor VII
- Where
- 9 sites in Australia, Austria and 7 more
- Volunteers
- 283 people
- Sponsor
- Novo Nordisk A/S
Coagulation Defects
Safety Study of Spray-Dried Solvent/Detergent-Treated Plasma for Infusion in Healthy Volunteers
This study is a Phase 1, single-center, open-label, ascending dose study which will assess the safety and tolerability of 5 doses of spray-dried solvent/detergent treated plasma (Resusix®) in healthy volunteers.
- Trial name
- NCT01589666
- Testing
- Spray-dried S/D-treated Plasma
- Where
- United States
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- Entegrion, Inc.
Congenital Bleeding Disorder, Haemophilia A
Intra-subject Variability Following Administrations of Activated Recombinant Human Factor VII in Haemophilia Patients in a Non-bleeding State
This trial is conducted in Asia and Europe. The aim of this trial is to evaluate the intra-subject variability of thromboelastographic parameters (TEG® and ROTEM®) following two administrations of activated recombinant human…
- Conditions
- Congenital Bleeding Disorder, Haemophilia A, Haemophilia B
- Trial name
- NCT01562457
- Testing
- activated recombinant human factor VII
- Where
- 3 sites in France, Germany and 1 more
- Volunteers
- 30 people
- Sponsor
- Novo Nordisk A/S
Primary Immune Thrombocytopenia
Safety and Efficacy Study of PF-06835375 in Primary Immune Thrombocytopenia
This is a Phase 2, open-label, multicenter, multiple subcutaneous injection, safety and efficacy study of PF-06835375 in adult participants with primary immune thrombocytopenia (ITP).
- Trial name
- NCT05070845
- Testing
- PF-06835375
- Where
- 24 sites in United States, Australia and 5 more
- Volunteers
- 61 people
- Sponsor
- Pfizer
Primary Myelofibrosis (PMF), Post Polycythaemia Myelofibrosis (PPV MF)
Exploratory Phase II Study of INC424 Patients With Primary Myelofibrosis (PMF) or Post Polycythaemia Myelofibrosis (PPV MF) or Post Essential Thrombocythaemia Myelofibrosis (PET-MF)
The primary objective of this study is to evaluate the efficacy of INC424 in patients with PMF, PPV MF, or PET-MF using a composite measure of either an objective endpoint (> 50% reduction in splenomegaly using palpitation at 48…
- Conditions
- Primary Myelofibrosis (PMF), Post Polycythaemia Myelofibrosis (PPV MF), Post Essential Thrombocythaemia Myelofibrosis (PET-MF)
- Trial name
- MACS2030 (NCT01558739)
- Testing
- INC424
- Where
- 10 sites in United Kingdom
- Volunteers
- 48 people
- Sponsor
- Novartis Pharmaceuticals
Immune Thrombocytopenic Purpura (ITP)
A Study to Assess the Ability of Eltrombopag to Induce Sustained Response Off Treatment in Subjects With ITP
The purpose of this trial was to assess the ability of eltrombopag to induce sustained treatment-free remission in immune thrombocytopenia purpura (ITP) subjects who relapsed or failed to respond to an initial treatment with…
- Trial name
- TAPER (NCT03524612)
- Testing
- eltrombopag
- Where
- 32 sites in United States, Austria and 13 more
- Volunteers
- 105 people
- Sponsor
- Novartis Pharmaceuticals
Haemostasis, Congenital Bleeding Disorder
Bridging Hemophilia B Experiences, Results and Opportunities Into Solutions (B-HERO-S)
This study is conducted in the United States of America (USA). Tha aim of this study is bridging Hemophilia B Experiences, Results and Opportunities into Solutions (B-HERO-S).
- Conditions
- Haemostasis, Congenital Bleeding Disorder, Haemophilia B
- Trial name
- NCT02568202
- Testing
- No treatment given
- Where
- United States
- Volunteers
- 449 people
- Sponsor
- Novo Nordisk A/S
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