Clinical trials: Disorders, Blood Coagulation
Severe Hemophilia A
rFVIII-Fc (Produced by AryoGen Pharmed Co.) Pharmacokinetic Study
The study is designed as a randomized, two-armed, double-blind, single-dose, crossover, two-sequence, active-controlled, multi-center, bioequivalence clinical trial with a primary endpoint of dose-normalized area under the curve…
- Trial name
- NCT06137092
- Testing
- Factor VIII, recombinant human with Fc fusion (rFVIII-Fc)
- Where
- 5 sites in Iran
- Volunteers
- 50 people
- Sponsor
- AryoGen Pharmed Co.
Hemophilia A
A Gene Transfer Study for Hemophilia A
This clinical research study is being conducted by Spark Therapeutics, Inc. to determine the safety and efficacy of the factor VIII gene transfer treatment with SPK-8011 in individuals with hemophilia A.
- Trial name
- NCT03003533
- Testing
- SPK-8011
- Where
- 16 sites in United States, Australia and 3 more
- Volunteers
- 25 people
- Sponsor
- Spark Therapeutics, Inc.
Hemophilia A
A Study to Evaluate Impact of Efanesoctocog Alfa on Long-term Joint Health in Participants With Hemophilia A
This is a prospective, observational, multi-center longitudinal cohort study to describe the real-world effectiveness, safety and treatment usage of efanesoctocog alfa in patients with hemophilia A treated per standard of care in…
- Trial name
- NCT05911763
- Testing
- Efanesoctocog Alfa BIVV001
- Where
- 28 sites in United States
- Volunteers
- 200 people
- Sponsor
- Sanofi
Hemophilia A
Joint Status in Subjects With Severe Hemophilia A in Relation to Different Treatment Regimens
The joint status (knees, ankles) of patients suffering from severe Hemophilia A (too little blood clotting factor VIII in blood) is evaluated in a single magnetic resonance imaging session. No study medication is given.
- Trial name
- NCT00927667
- Testing
- No Drug
- Where
- 15 sites in Germany, Greece and 4 more
- Volunteers
- 156 people
- Sponsor
- Bayer
Von Willebrand Diseases
Bleeding Incidence in VWD Patients Undergoing On-Demand Treatment
The purpose of this study is to prospectively obtain reliable data on the bleeding and treatment pattern of patients with VWD undergoing on-demand treatment with a VWF-containing product over a period of 6 months.
- Trial name
- NCT04053699
- Testing
- Von Willebrand Factor-Containing Product
- Where
- 15 sites in United States, Belarus and 6 more
- Volunteers
- 56 people
- Sponsor
- Octapharma
Primary Immune Thrombocytopenia (ITP)
A Phase Ib/II Clinical Trial of Multiple Doses of STSA-1301 Subcutaneous Injection in Healthy Subjects and Patients With Immune Thrombocytopenia (ITP)
A randomized, double-blind, placebo-controlled design was designed to evaluate the safety and tolerability, pharmacokinetic/pharmacodynamic profile, and immunogenicity of multiple administration of STSA-1301 subcutaneous…
- Trial name
- NCT06929299
- Testing
- STSA-1301 subcutaneous injection
- Where
- 7 sites in China
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Jiangsu BioJeTay Biotechnology Co., Ltd.
Healthy Participants, Hemophilia A
A Study of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SR604 in Two Participants Groups (Part A: Healthy Participants, and Part B: Participants With Hemophilia A or Hemophilia B or Factor VII Deficiency)
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamic (PD) of SR604 in healthy participants (Part A) and to evaluate the safety, tolerability, PK, PD, and efficacy of SR604…
- Conditions
- Healthy Participants, Hemophilia A, Hemophilia B, Factor VII Deficiency
- Trial name
- NCT06349473
- Testing
- SR604
- Where
- 10 sites in United States, Canada
- Volunteers
- 31 people, healthy volunteers welcome
- Sponsor
- Equilibra Bioscience LLC
Immune Thrombocytopenia, ITP
An Observational, Multicenter Study to Evaluate the Use and Effectiveness of Doptelet® in Patients With ITP
This is a multi-center, observational, Phase 4 study in patients with Immune Thrombocytopenia (ITP) designed to describe the real-world effectiveness of Doptelet and assess the patterns of drug utilization to add to the knowledge…
- Trial name
- ADOPT (NCT04943042)
- Testing
- Avatrombopag
- Where
- 55 sites in Croatia, Czechia and 7 more
- Volunteers
- 199 people
- Sponsor
- Swedish Orphan Biovitrum
Thrombocythemia, Essential
Safety and Pregnancy Outcomes in Thrombocythemia Patients Exposed to XAGRID® (Anagrelide Hydrochloride) Compared to Other Treatments
This is an observational safety study being conducted in Europe comparing patients taking Xagrid to patients taking other cytoreductive treatments.
- Trial name
- NCT00567502
- Where
- 164 sites in Cyprus, Denmark and 12 more
- Volunteers
- 3,647 people
- Sponsor
- Shire
Hemophilia A With Inhibitor, Hemophilia B With Inhibitor
A Phase I of SS109 in Hemophilia A or and B With Inhibitors
This phase I study aims to evaluate the safety, PK/PD and immunogenicity of SS109 in hemophilia A or and B with inhibitors. Twenty -seven patients are enrolled in study, and divided into five dose cohorts, from 30μg/kg to…
- Conditions
- Hemophilia A With Inhibitor, Hemophilia B With Inhibitor, Factor VII Deficiency
- Trial name
- NCT05651061
- Testing
- SS109
- Where
- 10 sites in China
- Volunteers
- 27 people
- Sponsor
- Hangzhou Gensciences Biopharmaceutical Co., Ltd.
Von Willebrand Disease
Efficacy of Alphanate FVIII/VWF Concentrate in Type 3 Von Willebrand Patients
To assess the efficacy of FVIII/VWF Complex (Human), Alphanate® as replacement therapy in preventing excessive bleeding in subjects with congenital Type 3 von Willebrand Disease (VWD) who undergo surgical procedures.
- Trial name
- NCT00555555
- Testing
- Alphanate SD/HT
- Volunteers
- 4 people
- Sponsor
- Grifols Biologicals, LLC
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.
Factor XIII Deficiency
An Open Enrollment Study of Factor XIII Concentrate in Subjects With Congenital Factor XIII Deficiency
Congenital deficiency of factor XIII is an extremely rare inherited disorder associated with potentially life-threatening bleeding. Factor XIII Concentrate is given to patients whose blood is lacking factor XIII.
- Trial name
- NCT00945906
- Testing
- FXIII Concentrate (Human) (FXIII)
- Where
- 25 sites in United States
- Volunteers
- 61 people
- Sponsor
- CSL Behring
Congenital Bleeding Disorder, Haemophilia A
Impact of Pain on Functional Impairment and Quality of Life in Adults With Hemophilia
This study is conducted in the United States of America (USA). The aim of the study is to assess the impact of pain on functional impairment and quality of life in adult persons with hemophilia (PWH) with and without inhibitors…
- Conditions
- Congenital Bleeding Disorder, Haemophilia A, Haemophilia A With Inhibitors, Haemophilia B
- Trial name
- NCT01988532
- Testing
- No treatment given
- Where
- United States
- Volunteers
- 381 people
- Sponsor
- Novo Nordisk A/S
Hemophilia A
Post Marketing Surveillance To Observe Safety And Efficacy Of Xyntha® In Subjects With Hemophilia A
This study is to describe the safety and efficacy of Xyntha® during the usual care setting.
- Trial name
- NCT01790828
- Testing
- Xyntha : coagulation factor IIIV (recombinant)
- Where
- 4 sites in South Korea
- Volunteers
- 42 people
- Sponsor
- Pfizer
Congenital Bleeding Disorder, Congenital FXIII Deficiency
Safety and Efficacy of Monthly Replacement Therapy With Recombinant Factor XIII (rFXIII) in Paediatric Subjects With Congenital Factor XIII A-subunit Deficiency
This trial will be conducted in Asia, Europe and the United States of America (USA). The aim of this clinical trial is to investigate long-term safety of rFXIII when administered for prevention of bleeding episodes in children…
- Trial name
- mentor™5 (NCT01253811)
- Testing
- catridecacog
- Where
- 4 sites in United States, Israel and 1 more
- Volunteers
- 6 people
- Sponsor
- Novo Nordisk A/S
Acquired Bleeding Disorder, Trauma
Incidence/Magnitude-Haemorrhagic Progression-Cerebral Contusions and Identification (ID) of Safety Issues After Traumatic Brain Injury
This study is conducted in North America. The purpose of this study is to evaluate the occurrence and severity of bleeding in brain injury and to identify important safety issues following traumatic brain injury.
- Trial name
- NCT00124293
- Testing
- activated recombinant human factor VII
- Where
- 2 sites in United States, Canada
- Volunteers
- 63 people
- Sponsor
- Novo Nordisk A/S
Idiopathic Thrombocytopenic Purpura
Safety Study of GMA161 in Patients With Idiopathic Thrombocytopenic Purpura (ITP)
This study is designed to investigate the safety of a single infusion of GMA161 in patients with idiopathic thrombocytopenic purpura, as well as, the way the drug enters and leaves the body.
- Trial name
- NCT00244257
- Testing
- GMA161
- Where
- 6 sites in United States
- Volunteers
- 10 people
- Sponsor
- Genzyme, a Sanofi Company
Acquired Thrombotic Thrombocytopenic Purpura (aTTP)
Study of rADAMTS-13 (SHP655) in the Treatment of Participants With Acquired Thrombotic Thrombocytopenic Purpura (aTTP)
The purpose of this study is to evaluate the pharmacokinetics, safety, and efficacy of rADAMTS-13 (SHP655) administered in addition to standard of care (SoC) treatment of acquired thrombotic thrombocytopenic purpura (aTTP)…
- Trial name
- SOAR-HI (NCT03922308)
- Testing
- SHP655, Standard of Care
- Where
- 24 sites in United States, Canada and 5 more
- Volunteers
- 28 people
- Sponsor
- Shire
Blood Coagulation Disorders
ROTEM® Sigma Performance Evaluation - Method Comparison With Predicate Device and Reference Intervals
ROTEM® sigma is a new thromboelastometric coagulation analysis system. The new system is fully automated allowing for a simple and safe operation compared to its predecessor model ROTEM® delta.
- Trial name
- ROSI-EVA (NCT02379104)
- Testing
- ROTEM sigma
- Where
- 5 sites in United States, Austria and 1 more
- Volunteers
- 240 people, healthy volunteers welcome
- Sponsor
- Tem Innovations GmbH
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