Clinical trials: Disorders, Blood Coagulation
Hemophilia A
Study of Modified Recombinant Factor VIII (OBI-1) in Subjects With Congenital Hemophilia A
This study is to test whether the study drug (OBI-1) is safe and effective for the treatment of serious bleeding episodes in people with congenital hemophilia A.
- Trial name
- NCT01434511
- Testing
- OBI-1
- Where
- 3 sites in United States, South Africa and 1 more
- Volunteers
- 1 people
- Sponsor
- Baxalta now part of Shire
Hemophilia A
Study to Compare How the Body Distributes and Excretes the Drugs Jivi (BAY 94-9027) and Adynovi in Patients With Severe Hemophilia A (Bleeding Disorder Resulting From a Lack of Blood Clotting Factor VIII)
This study is being conducted to compare how the body distributes and excretes the drugs Jivi (BAY 94-9027) and Adynovi. Jivi is a recently approved blood clotting Factor VIII (FVIII) medication for the treatment of hemophilia A…
- Trial name
- NCT04015492
- Testing
- Damoctocog-alfa-pegol (BAY94-9027, Jivi), Rurioctocog alfa pegol (Adynovi)
- Where
- Bulgaria
- Volunteers
- 18 people
- Sponsor
- Bayer
Hemostasis, General Surgery
A Study Evaluating the Safety and Preliminary Efficacy of sFilm-FS in Controlling Parenchymal Bleeding During Elective Hepatic Surgery
The Study investigates a new product, sFilm-FS, aimed to help controlling body fluid leakage in general surgery procedures, proposing its use as an adjunct to hemostasis and/or sealing.
- Trial name
- NCT04660721
- Testing
- sFilm-FS, TACHOSIL®
- Where
- 4 sites in United States, Austria and 1 more
- Volunteers
- 33 people
- Sponsor
- Sealantium Medical Ltd.
Immune Thrombocytopenic Purpura
Open Label Trial on the Safety and Efficacy of Sym001 in the Treatment of Immune Thrombocytopenic Purpura (ITP)
This trial is designed as a multi-centre, single-dose, exploratory dose-finding, open label trial evaluating the safety and efficacy of Sym001 in 4-9 consecutive cohorts. Subjects will receive a single IV dose of Sym001.
- Trial name
- NCT00718692
- Testing
- Sym001
- Where
- 59 sites in United States, Belgium and 10 more
- Volunteers
- 61 people
- Sponsor
- Symphogen A/S
Primary Immune Thrombocytopenia
Intravenous Immunoglobulin (IVIG, Bioven) Efficacy and Safety in Chronic Primary Immune Thrombocytopenia (ITP) in Adults
The study will involve patients with chronic immune thrombocytopenia. This disease is diagnosed in the presence of isolated thrombocytopenia (decrease in platelet count only), except for other reasons.
- Trial name
- NCT05422365
- Testing
- Intravenous immunoglobulin (IVIG), 10% solution for infusion
- Where
- 12 sites in Ukraine
- Volunteers
- 32 people
- Sponsor
- Biopharma Plasma LLC
Hemophilia A
Early Prophylaxis Immunologic Challenge (EPIC) Study
The purpose of the study was to assess if a once-weekly prophylactic regimen of 25 IU/kg ADVATE started at or before 1 year of age and before the onset of a severe bleeding phenotype (ie, joint bleeding), together with the…
- Trial name
- EPIC (NCT01376700)
- Testing
- Recombinant antihemophilic factor, plasma/albumin-free method (rAHF-PFM)
- Where
- 19 sites in United States, Austria and 10 more
- Volunteers
- 22 people
- Sponsor
- Baxalta now part of Shire
Idiopathic Thrombocytopenic Purpura
A Clinical Study in Patients With Chronic Idiopathic Thrombocytopenic Purpura in R788
The purpose of this study is to investigate the efficacy, safety and pharmacokinetics of R788 compared with placebo, and to investigate the safety and efficacy of long term dosing of R788 in patients with chronic idiopathic…
- Trial name
- NCT04132050
- Testing
- R788
- Where
- Japan
- Volunteers
- 34 people
- Sponsor
- Kissei Pharmaceutical Co., Ltd.
Hemophilia A
Study Evaluating Safety Of Patients Switching To ReFacto AF In Usual Care Settings
The study will be investigating safety in patients who switch to ReFacto AF from ReFacto and other Factor VIII products.
- Trial name
- NCT00884390
- Testing
- moroctocog alfa (AF-CC) (ReFacto AF), Laboratory tests
- Where
- 74 sites in Austria, Belgium and 12 more
- Volunteers
- 208 people
- Sponsor
- Pfizer
Acquired Thrombotic Thrombocytopenic Purpura
Study to Assess Efficacy and Safety of Anti-von Willebrand Factor (vWF) Nanobody in Patients With Acquired Thrombotic Thrombocytopenic Purpura (aTTP)
This study was a Phase II, single-blind, randomized, placebo-controlled trial to determine whether anti-vWF Nanobody is safe and effective as adjunctive treatment in patients with aTTP.
- Trial name
- TITAN (NCT01151423)
- Testing
- Caplacizumab
- Where
- 51 sites in United States, Australia and 11 more
- Volunteers
- 75 people
- Sponsor
- Ablynx, a Sanofi company
Immune Thrombocytopenia (ITP)
The Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of HMPL-523 in Immune Thrombocytopenia Patients
This is a randomized, double blinded, placebo-controlled phase Ib clinical trial in adult patients with immune thrombocytopenia. Cross-over treatment will be allowed during the study.
- Trial name
- NCT03951623
- Testing
- HMPL-523
- Where
- China
- Volunteers
- 45 people
- Sponsor
- Hutchison Medipharma Limited
Haemophilia A, Haemophilia B
A Study to Evaluate the Real-world Usage and Effectiveness of Elocta and Alprolix in Patients With Haemophilia A or B
Elocta (rFVIIIFc) and Alprolix (rFIXFc) are recombinant extended half-life coagulation factor products. The purpose of this non-interventional study is to describe the real-world usage and effectiveness of Elocta and Alprolix in…
- Trial name
- PREVENT (NCT03055611)
- Testing
- ELOCTA, ALPROLIX
- Where
- 22 sites in Germany
- Volunteers
- 201 people
- Sponsor
- Swedish Orphan Biovitrum
Hemophilia A, Hemophilia B
Study of the Efficacy and Safety PF-06741086 in Adult and Teenage Participants With Severe Hemophilia A or Moderately Severe to Severe Hemophilia B
Treatment with PF-06741086 is anticipated to demonstrate a clinically relevant advantage and/or a major contribution to patient care in comparison to current methods of treatment for hemophilia A or B because it works differently…
- Trial name
- NCT03938792
- Testing
- PF-06741086
- Where
- 62 sites in United States, Bulgaria and 18 more
- Volunteers
- 188 people
- Sponsor
- Pfizer
Male, Hemophilia A With Inhibitor
SS109 and NovoSeven ® PK / PD Profile, and Preliminary Efficacy and Safety of SS109 on Demand Treatment
This is an open-label, multicenter Phase 1Ib/2II clinical trial of SS109 in adult hemophilia patients (≥ 18 years) with FVIII or FIX inhibitors to evaluate the PK/PD profile of SS109 and NovoSeven® after a single dose in adult…
- Conditions
- Male, Hemophilia A With Inhibitor, Hemophilia B With Inhibitor, Hemophilia
- Trial name
- NCT06010953
- Testing
- SS109
- Where
- 9 sites in China
- Volunteers
- 24 people
- Sponsor
- Hangzhou Gensciences Biopharmaceutical Co., Ltd.
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
Hemophilia A
Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Recombinant Coagulation Factor VIII Fc Fusion Protein (rFVIIIFc) in Previously Treated Pediatric Subjects With Hemophilia A
The primary objective of the study is to evaluate the safety of Recombinant Coagulation Factor VIII Fc Fusion Protein (rFVIIIFc) in previously treated pediatric subjects with hemophilia A.
- Trial name
- Kids ALONG (NCT01458106)
- Testing
- BIIB031 (rFVIIIFc), FVIII (PK subgroup only)
- Where
- 23 sites in United States, Australia and 6 more
- Volunteers
- 71 people
- Sponsor
- Bioverativ Therapeutics Inc.
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.
Pancreatic Cancer, Ductal Adrenocarcinoma
Study of Safety and Tolerability of PCI-27483 in Patients With Pancreatic Cancer Patients Receiving Treatment With Gemcitabine
The purpose of this study is to evaluate the safety and tolerability of selected dose 1.2mg/kg BID dosage administered subcutaneously (SC) administered PCI-27483 to metastatic or locally advanced pancreatic cancer patients…
- Conditions
- Pancreatic Cancer, Ductal Adrenocarcinoma, Exocrine Pancreatic Cancer
- Trial name
- NCT01020006
- Testing
- PCI-27483, Gemcitabine
- Where
- 17 sites in United States
- Volunteers
- 42 people
- Sponsor
- Pharmacyclics LLC.
Primary Immune Thrombocytopenia
A Study of Efficacy and Safety of Ianalumab Versus Placebo in Addition to Eltrombopag in Primary Immune Thrombocytopenia Patients Who Failed Steroids
The purpose of this study is to evaluate the effect of two different doses of ianalumab added to eltrombopag to prolong Time to Treatment Failure (TTF) in adults with primary ITP who failed previous first-line treatment with…
- Trial name
- VAYHIT2 (NCT05653219)
- Testing
- Ianalumab, Eltrombopag
- Where
- 74 sites in United States, Argentina and 22 more
- Volunteers
- 152 people
- Sponsor
- Novartis Pharmaceuticals
Immune Thrombocytopenia
Safety and Efficacy of GL-2045 in Patients With Immune Thrombocytopenia
The goal of this clinical trial is to demonstrate GL-2045 safety and efficacy proof of concept by demonstrating intravenous immunoglobulin (IVig)-like platelet responses in adult patients with Immune Thrombocytopenia (ITP).
- Trial name
- NCT07605845
- Testing
- GL-2045
- Where
- United Kingdom
- Volunteers
- 42 people
- Sponsor
- Gliknik Inc.
Haemophilia A
Post-Marketing Surveillance (Use-results Surveillance) With Esperoct®
The purpose of this study is to assess the safety and effectiveness of Esperoct® for long-term routine use in patients with Haemophilia A. Participants will get Esperoct® as prescribed by their doctor.
- Trial name
- NCT04334057
- Testing
- Turoctocog alfa pegol
- Where
- 20 sites in Japan
- Volunteers
- 23 people
- Sponsor
- Novo Nordisk A/S
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