Clinical trials: Disorders, Blood Coagulation
Hemophilia A
A Study to Learn More About Treatment With Damoctocog Alfa Pegol, How it is Used in Every Day Practice ("Real-World"), and How Satisfied People Who Receive Damoctocog Alfa Pegol Are in United States (US) Hemophilia Treatment Centers
People with hemophilia A do not have enough of a protein found naturally in the blood called "clotting factor 8", also known as FVIII. This protein helps the blood to clump together to prevent and stop bleeding.
- Trial name
- REAL (NCT05395858)
- Testing
- No intervention
- Where
- 3 sites in United States
- Volunteers
- 14 people
- Sponsor
- Bayer
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.
Essential Thrombocythemia, Primary Myelofibrosis, Fibrotic Stage
18F-FLT (PET/CT) in Pediatrics With Myeloproliferative Neoplasms
The Main purpose of this project to study the uptake pattern of FLT-PET and it is value in assessing the malignant hematopoiesis in MPN within the pediatric age group, in terms of diagnosis, staging and monitoring response to…
- Conditions
- Essential Thrombocythemia, Primary Myelofibrosis, Fibrotic Stage, Primary Myelofibrosis, Prefibrotic Stage, Polycythemia Vera
- Trial name
- NCT03121599
- Testing
- Diagnostic (18F-FLT PET/CT)
- Where
- Qatar
- Volunteers
- 3 people
- Sponsor
- Hamad Medical Corporation
Haemophilia A
A Research Study Investigating Denecimig (Mim8) in Adults With Acquired Haemophilia A
The purpose of this study is to find out if denecimig is safe and effective for treating people who have acquired haemophilia A. Participants will be in this study for up to around 1 year and 5 months (73 week).
- Trial name
- FRONTIERAHA (NCT07830732)
- Testing
- Denecimig
- Where
- 83 sites in United States, Argentina and 16 more
- Volunteers
- 84 people
- Sponsor
- Novo Nordisk A/S
Hemophilia a, Hemophilia B
Study of TU7710 in Warfarin Anti-coagulated Healthy Male Subjects
This is a Phase 1a, double-blind, randomized, placebo- controlled, SAD study to assess safety, tolerability, PK, and PD of TU7710 in warfarin treated healthy male participants.
- Conditions
- Hemophilia a, Hemophilia B, Blood Coagulation Disorders
- Trial name
- NCT06025552
- Testing
- TU7710, Normal saline
- Where
- South Korea
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- TiumBio Co., Ltd.
Congenital Bleeding Disorder, Haemophilia A With Inhibitors
PROPACT: Retrospective Prophylaxis Patient Case Collection
This study is conducted in Europe and North and South America. The primary aim of this observational study is to evaluate the frequency and pattern of bleeding episodes in haemophilia patients receiving preventative treatment…
- Conditions
- Congenital Bleeding Disorder, Haemophilia A With Inhibitors, Haemophilia B With Inhibitors
- Trial name
- PROPACT (NCT00882778)
- Testing
- eptacog alfa (activated)
- Where
- 14 sites in United States, Argentina and 12 more
- Volunteers
- 86 people
- Sponsor
- Novo Nordisk A/S
Hemophilia A
A Clinical Study to Evaluate the Effects of NXT007 Compared to Factor VIII Prophylaxis in Participants With Hemophilia A
The purpose of this study is to evaluate the efficacy, safety, pharmacokinetics and pharmacodynamics of NXT007 prophylaxis compared with Factor VIII (FVIII) prophylaxis in participants with severe or moderate congenital…
- Trial name
- ZEBRHA 1 (NCT07416526)
- Testing
- NXT007, Human Coagulation Factor VIII
- Where
- 36 sites in United States, Argentina and 16 more
- Volunteers
- 138 people
- Sponsor
- Hoffmann-La Roche
Haemophilia A
Validation Study of a cOmputer Pharmacokinetic Tool to assIst in the Follow up Care of haeMophilia A Patients
OPTIMS is a non interventional validation study of the calculator developed by Bayer for clinician's use in the prophylactic treatment by factor VIII of patients with severe or moderate Haemophilia A with a severe clinical…
- Trial name
- OPTIMS (NCT01436825)
- Testing
- Recombinant Factor VIII (Kogenate FS, BAY14-2222)
- Where
- 2 sites in France, Italy
- Volunteers
- 69 people
- Sponsor
- Bayer
Hemophilia B, Hemophilia A
A Study to Evaluate Prospective Efficacy and Safety Data of Current FIX Prophylaxis Replacement Therapy in Adult Hemophilia B Subjects (FIX:C≤2%) or Current FVIII Prophylaxis Replacement Therapy in Adult Hemophilia A Subjects (FVIII:C≤1%)
To establish baseline prospective efficacy data of current FIX prophylaxis replacement therapy in the usual care setting of hemophilia B subjects, who are negative for nAb to AAV-Spark100, prior to the Phase 3 gene therapy study.
- Trial name
- NCT03587116
- Testing
- Standard of Care FIX Replacement therapy, Standard of Care FVIII Replacement therapy
- Where
- 75 sites in United States, Australia and 16 more
- Volunteers
- 212 people
- Sponsor
- Pfizer
Hemophilia A
Study Evaluating The Efficacy And Safety Of Xyntha In Children Less Than 6 Years Of Age
This study will be investigating the safety and efficacy of Xyntha (moroctocog alfa (AF-CC)) in male patients less than 6 years old.
- Trial name
- NCT00759655
- Testing
- Moroctocog alfa
- Volunteers
- 1 people
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Congenital Thrombotic Thrombocytopenic Purpura
Prospective Psychometric Evaluation Study of a Patient-reported Outcomes (PRO) Instrument for Congenital Thrombotic Thrombocytopenic Purpura (cTTP, Upshaw-Schulman Syndrome [USS], Hereditary Thrombotic Thrombocytopenic Purpura [hTTP]
The purpose of this study is to assess the psychometric properties of a recently developed congenital thrombotic thrombocytopenic purpura (cTTP)-specific patient-reported outcomes (PRO) instrument.
- Trial name
- NCT03519672
- Testing
- No intervention
- Where
- 4 sites in United States, United Kingdom
- Volunteers
- 41 people
- Sponsor
- Baxalta now part of Shire
Disseminated Intravascular Coagulation (DIC)
An Open-label Study of KW-3357
The purpose of this study is to evaluate the efficacy and safety of KW-3357 compared to plasma-derived antithrombin using multi-center, open-label, parallel-group, comparative method in patients with Disseminated Intravascular…
- Trial name
- 3357-004 (NCT01384903)
- Testing
- KW-3357, Plasma-derived antithrombin
- Where
- Japan
- Volunteers
- 221 people
- Sponsor
- Kyowa Kirin Co., Ltd.
Congenital Bleeding Disorder, Haemophilia B
Safety, Efficacy and Pharmacokinetics of NNC-0156-0000-0009 in Previously Treated Children With Haemophilia B.
This trial is conducted in Asia, Europe and North America. The aim of the trial is to evaluate safety, efficacy and pharmacokinetics (the exposure of the trial drug in the body) of NNC-0156-0000-0009 (nonacog beta pegol, N9-GP)…
- Trial name
- paradigm™5 (NCT01467427)
- Testing
- nonacog beta pegol
- Where
- 51 sites in United States, Brazil and 10 more
- Volunteers
- 25 people
- Sponsor
- Novo Nordisk A/S
Purpura, Thrombocytopenic, Idiopathic
Rapid Infusion Of Immune Globulin Intravenous (IGIV) In Patients With ITP
The objective of this study is to determine if the safety and tolerability of Immune Globulin Intravenous (Human), 10% Caprylate/Chromatograph Purified (IGIV-C) is similar when infused at two different infusion rates.
- Trial name
- NCT00220727
- Testing
- Immune Globulin IV [Human], 10% Caprylate/Chromatography Purified
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- Grifols Therapeutics LLC
Haemophilia B
Adverse Event Data Collection From External Registries on Nonacog Beta Pegol
The purpose of this study is to collect data on adverse events from third party registries that include information about adverse events from patients with haemophilia B treated with nonacog beta pegol.
- Trial name
- NCT03690336
- Testing
- Nonacog beta pegol
- Where
- 2 sites in Netherlands, United Kingdom
- Volunteers
- 10 people
- Sponsor
- Novo Nordisk A/S
Congenital Bleeding Disorder, Haemophilia A
Safety, Tolerability, and Pharmacokinetics Study of Turoctocog Alfa Pegol Injected Under the Skin in Patients With Haemophilia A
The trial is conducted in Asia, Europe and North America. The aim of the study is to evaluate the safety of administration under the skin of turoctocog alfa pegol (SC N8-GP) in patients with severe haemophilia A.
- Trial name
- alleviate 1 (NCT02994407)
- Testing
- turoctocog alfa pegol
- Where
- 19 sites in United States, Austria and 4 more
- Volunteers
- 50 people
- Sponsor
- Novo Nordisk A/S
Thrombocytopenia, Idiopathic Thrombocytopenic Purpura
AMG 531 Treatment of Thrombocytopenic Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP) Prior to Splenectomy
The purpose of this study is to evaluate the efficacy of AMG 531 in the treatment of thrombocytopenia in subjects with ITP as measured by the platelet response.
- Trial name
- NCT00102336
- Testing
- AMG 531
- Volunteers
- 62 people
- Sponsor
- Amgen
Hemophilia A
Pharmacokinetics Evaluation of Recombinant Coagulation Factor VIII Injection in Subjects With Hemophilia A.
This is a multi-center, open-label, randomized study. Participants will be assigned to A or B groups with a scale of 1:1 , i.e. infuse study drug followed by Xyntha (group A), or the alternate sequence (group B).
- Trial name
- NCT04060836
- Testing
- Xyntha, Recombinant Coagulation Factor VIII Injection
- Where
- 5 sites in China
- Volunteers
- 24 people
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Purpura, Thrombocytopaenic, Idiopathic
RAISE: Randomized Placebo-Controlled Idiopathic Thrombocytopenic Purpura (ITP) Study With Eltrombopag
The rationale for this Phase III study is to evaluate the 6 month safety and efficacy of eltrombopag in the treatment of previously treated subjects with chronic ITP.
- Trial name
- RAISE (NCT00370331)
- Testing
- eltrombopag
- Where
- 115 sites in United States, Austria and 23 more
- Volunteers
- 197 people
- Sponsor
- GlaxoSmithKline
Hemophilia A
Pharmacokinetic Study of ADVATE Reconstituted in 2 mL Sterile Water for Injection
The purpose of this study is to determine the pharmacokinetics and safety of Antihemophilic factor, recombinant, manufactured protein-free (rAHF-PFM) reconstituted in 2 mL sterile water for injection (SWFI) and compare with those…
- Trial name
- NCT00952822
- Testing
- Antihemophilic factor, recombinant, manufactured protein-free (rAHF-PFM). (Antihemophilic factor is also known as Factor VIII)
- Where
- 11 sites in United States
- Volunteers
- 52 people
- Sponsor
- Baxalta now part of Shire
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