Clinical trials: Coagulation Protein Disorders
Hemophilia A
Hemophilia Inhibitor Previously Untreated Patient Study
Hemophilia A is a congenital bleeding disorder caused by deficiency of factor VIII (FVIII) and is treated by replacement therapy with FVIII concentrate.
- Trial name
- HIPS (NCT01652027)
- Testing
- FVIII concentrate
- Where
- 17 sites in United States, Austria and 3 more
- Volunteers
- 25 people
- Sponsor
- The University of Texas Health Science Center, Houston
Hemophilia A, Hemophilia B
A Single Escalating Dose and Multiple Dose Study of BAY 1093884 in Subjects With Severe Hemophilia Types A or B, With or Without Inhibitors
Investigate the safety, tolerability and pharmacokinetics of BAY1093884 after Intravenous (IV) and subcutaneous (SC) administration of increasing single doses and SC administration of multiple doses.
- Trial name
- NCT02571569
- Testing
- BAY1093884
- Where
- 10 sites in Bulgaria, Germany and 3 more
- Volunteers
- 32 people
- Sponsor
- Bayer
Hemophilia
Haemophilia and Bone Loss - PHILEOS Study
Haemophilia is a rare bleeding disorder, characterized by factor VIII (HA) or factor IX (HB) deficiency. The absence or the reduction of fVIII or fIX result in impaired thrombin generation and clot formation, causing excessive…
- Trial name
- PHILEOS (NCT04384341)
- Testing
- Bone densitometry (BMD), Blood sampling for patients only
- Where
- 23 sites in Belgium, Croatia and 3 more
- Volunteers
- 448 people, healthy volunteers welcome
- Sponsor
- Centre Hospitalier Universitaire de Saint Etienne
Hemophilia, Arthritis
Effectiveness of Manual Therapy and Strengthening Exercises in Hemophilic Arthropathy of the Elbow Joint
Manual treatment involves techniques based on the principles of moving the joint faces and separating the joint gap, and soft tissues mobilization techniques.
- Trial name
- NCT04308876
- Testing
- Manual therapy, Strengthening exercises
- Where
- Turkey (Türkiye)
- Volunteers
- 17 people
- Sponsor
- Necmettin Erbakan University
Hemophilia A
Kogenate FS Regulatory Post-Marketing Surveillance
To obtain data on safety, efficacy, and tolerability of KOGENATE FS under real-life conditions in its registered indications. The observation period for each patient is up to 6 months.
- Trial name
- KG0910KR (NCT01386268)
- Testing
- Recombinant Factor VIII (Kogenate FS, BAY14-2222)
- Where
- South Korea
- Volunteers
- 64 people
- Sponsor
- Bayer
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.
Hemophilia A, Factor VIII (FVIII)
TG-INSIGHT With Joint POCUS, Hemostatic Potential in Patients With Severe Hemophilia A on Novel Replacement and Substitution FVIII Therapies
This is an observational research study to find out if there is a difference in the way children with moderate or severe hemophilia A, treated on two different types of factor replacement, form a clot and also evaluate if they…
- Trial name
- NCT07692217
- Testing
- Half-life factor VIII based replacement therapy, Non-FVIII based replacement therapy
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- University of Texas Southwestern Medical Center
Blood Coagulation Disorders, Hemophilia A
Trial to Evaluate the Efficacy and Safety of a New Full Length Recombinant Human FVIII for Hemophilia A
The study will assess the pharmacokinetics (part A) safety, tolerability, and efficacy of prophylaxis treatment (2 to 3 times a week) (part B) with BAY81-8973 over a one year period (split into two six month treatment periods).
- Trial name
- Leopold I (NCT01029340)
- Testing
- Recombinant Factor VIII (BAY81-8973), Recombinant Factor VIII (Kogenate FS, BAY14-2222)
- Where
- 60 sites in United States, Argentina and 20 more
- Volunteers
- 74 people
- Sponsor
- Bayer
Inherited Bleeding Disorders
Study to Evaluate the Use of Ultrasound in the Diagnosis of Hemophilic Joint Disease
The purpose of this study is to see whether power Doppler sonography (PDS) can be used to diagnose synovitis in patients with inherited bleeding disorders.
- Trial name
- NCT00212485
- Testing
- Power Doppler Sonography, MRI
- Where
- United States
- Volunteers
- 43 people
- Sponsor
- New York Presbyterian Hospital
Hemophilia
Manual Therapy in the Treatment of Hemophilic Arthropathy of the Ankle
Introduction: Hemophilic ankle arthropathy is manifested by degenerative functional alterations (deficit of muscle strength, mobility and proprioception), intra-articular alterations and chronic pain.
- Trial name
- NCT05549843
- Testing
- Manual therapy
- Where
- Spain
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Investigación en Hemofilia y Fisioterapia
Von Willebrand Disease (VWD), Heavy Menstrual Bleeding (HMB)
HMBeacon: A Phase 2 Study to Evaluate ALN-6400 in Adult and Adolescent Female Patients With VWD and HMB
The purpose of this study is to evaluate the safety, tolerability, efficacy, and pharmacodynamics (PD) of multiple doses of ALN-6400 in adult and adolescent patients with VWD and HMB
- Trial name
- HMBeacon (NCT07575308)
- Testing
- ALN-6400
- Where
- 21 sites in United States, Netherlands and 3 more
- Volunteers
- 24 people
- Sponsor
- Alnylam Pharmaceuticals
Protein C Deficiency
Ghrelin Levels in Patients With Protein C Deficiency
In rodents with protein C deficiency elevated levels of ghrelin has been observed. The purpose of this study is to investigate if patients with protein C deficiency also have elevated levels of ghrelin, and if so, how this…
- Trial name
- NCT04180657
- Testing
- Protein C deficiency
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- University of Aarhus
Chronic Pain, Hemophilia
Chronic Pain and Hemophilia
Hemophilia (A and B) are X-linked hereditary bleeding disorders whose severity depends on the level of coagulation factor (FVIII or FIX respectively). Bleeding is mainly from joints (hemarthrosis) and muscles (hematoma).
- Trial name
- HEMODOL (NCT05202951)
- Testing
- questionnaires
- Where
- 10 sites in France
- Volunteers
- 350 people
- Sponsor
- University Hospital, Clermont-Ferrand
Severe Hemophilia
Study to Evaluate Safety and Tolerability of a Single Dose of PF-06741086 in Chinese Adult Participants With Severe Hemophilia
This Phase 1 study will be a single-arm, open-label, non-randomized, non-controlled investigation of the safety, tolerability, pharmacokinetics, and pharmacodynamics of PF-06741086 in Chinese adult participants with severe…
- Trial name
- NCT04878731
- Testing
- PF-06741086
- Where
- China
- Volunteers
- 6 people
- Sponsor
- Pfizer
Hemophilia A, Gene Therapy
Gene Therapy Study in Severe Hemophilia A Patients With Antibodies Against AAV5
This study is being conducted by BioMarin Pharmaceutical Inc. as an open label, single dose study to determine the safety of valoctocogene roxaparvovec (an Adenovirus-Associated Virus (AAV) based gene therapy vector) in severe…
- Conditions
- Hemophilia A, Gene Therapy, Clotting Disorders, Blood Disorder
- Trial name
- GENEr8-AAV5+ (NCT03520712)
- Testing
- Valoctocogene Roxaparvovec
- Where
- 9 sites in South Africa, South Korea and 2 more
- Volunteers
- 3 people
- Sponsor
- BioMarin Pharmaceutical
Von Willebrand Disease, Congenital Coagulation Factors Deficiency
Evaluation of Menses in Congenital Bleeding Disorders
Menorrhagia is the term used to define excessive menstrual blood losses, as often based on a subjective judgment of women. Many arbitrary values, expressed in milliliters of blood, have been proposed to define this symptom: 60 on…
- Conditions
- Von Willebrand Disease, Congenital Coagulation Factors Deficiency, Haemophilia Carriers
- Trial name
- MEVA-3 (NCT01261936)
- Where
- 3 sites in Italy
- Volunteers
- 30 people
- Sponsor
- University of L'Aquila
Low Von Willebrand Factor
Genetic Background of Patients With Low Von Willebrand Factor Levels
Von Willebrand disease (VWD) is caused by either quantitative or qualitative von Willebrand (VWF) defects and is the commonest inherited bleeding disorder with an estimated prevalence of about 1% in the general population.
- Trial name
- LOVMIC (NCT05116501)
- Testing
- Whole-exome sequencing
- Where
- Italy
- Volunteers
- 254 people, healthy volunteers welcome
- Sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Low Fibrinogen
F-Point Validation Study
The F-Point investigation is an open label, single centre prospective observational study in 3 cohorts of patients, one with low fibrinogen concentration, one with normal fibrinogen concentration, and one with high fibrinogen…
- Trial name
- F-Point (NCT03623061)
- Testing
- F-Point
- Where
- Ireland
- Volunteers
- 150 people
- Sponsor
- Royal College of Surgeons, Ireland
Blood Coagulation Disorder, Blood Coagulation Disorders, Inherited
Lead-in Study to Collect Prospective Efficacy and Safety Data of Current FVIII Prophylaxis Replacement Therapy in Adult Hemophilia A Participants
The aim of this prospective, observational study is to establish a dataset on the frequency of bleeding events, as well as other characteristics of bleeding events and FVIII infusions, in patients with clinically severe…
- Conditions
- Blood Coagulation Disorder, Blood Coagulation Disorders, Inherited, Coagulation Protein Disorders, Hemophilia A
- Trial name
- NCT03876301
- Testing
- Standard of Care FVIII Replacement therapy
- Where
- 11 sites in United States, Australia and 2 more
- Volunteers
- 25 people
- Sponsor
- Spark Therapeutics, Inc.
Hemophilia
Weight-based Dosing in Hemophilia A
Hemophilia A is an inherited (genetic) disease where a protein, factor VIII (FVIII), which promotes blood clotting is missing or does not work properly. Individuals with hemophilia A are at risk for bleeding.
- Trial name
- NCT02586012
- Testing
- rFVIII
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Craig Seaman
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