Humate-p (DrugBank: -)
1 disease| ID | Disease name (Link within this page) | Number of trials |
|---|---|---|
| 288 | Autoimmune acquired coagulation factor deficiency [Autoimmune Hemorrhaphilia XIII (~Mar 2017)] | 3 |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2004-004868-69-SE (EUCTR) | 25/04/2005 | 09/03/2005 | Study of Safety and Efficacy of Antihemophilic Factor / von Willebrand Factor Complex (Humate-P®) Using Individualized Dosing in Pediatric and Adult Surgical Subjectswith von Willebrand’s Disease | Study of Safety and Efficacy of Antihemophilic Factor / von Willebrand Factor Complex (Humate-P®) Using Individualized Dosing in Pediatric and Adult Surgical Subjectswith von Willebrand’s Disease | Von Willebrand’s disease (VWD) is a common hereditary bleeding disorder. The impaired formation and adhesion of the initial platelet plug is reflected in the prolonged skin bleeding time. In addition, reduced levels of von Willebrand factor:ristocetin cofactor activity, von Willebrand factor antigen, factor VIII coagulation activity, factor VIII antigen, and abnormalities of the multimeric structure of VWF are variably found among the several types and subtypes of VWD. MedDRA version: 7.1;Level: LLT;Classification code 10047715 | Trade Name: Humate-P Product Name: Humate-P Other descriptive name: Von Willebrand Factor Ristocetin Cofactor INN or Proposed INN: Factor VIII concentrate Other descriptive name: Factor VIII concentrate Other descriptive name: Von Willebrand Factor Antigen | ZLB Behring LLC | NULL | Not Recruiting | Female: yes Male: yes | 30 | Sweden | |||
| 2 | EUCTR2004-004868-69-AT (EUCTR) | 07/03/2005 | 31/01/2005 | Study of Safety and Efficacy of Antihemophilic Factor / von Willebrand Factor Complex (Humate-P®) Using Individualized Dosing in Pediatric and Adult Surgical Subjectswith von Willebrand’s Disease | Study of Safety and Efficacy of Antihemophilic Factor / von Willebrand Factor Complex (Humate-P®) Using Individualized Dosing in Pediatric and Adult Surgical Subjectswith von Willebrand’s Disease | Von Willebrand’s disease (VWD) is a common hereditary bleeding disorder. The impaired formation and adhesion of the initial platelet plug is reflected in the prolonged skin bleeding time. In addition, reduced levels of von Willebrand factor:ristocetin cofactor activity, von Willebrand factor antigen, factor VIII coagulation activity, factor VIII antigen, and abnormalities of the multimeric structure of VWF are variably found among the several types and subtypes of VWD. MedDRA version: 7.1;Level: LLT;Classification code 10047715 | Trade Name: Humate-P Product Name: Humate-P Other descriptive name: Von Willebrand Factor Ristocetin Cofactor INN or Proposed INN: Factor VIII concentrate Other descriptive name: Factor VIII concentrate Other descriptive name: Von Willebrand Factor Antigen | ZLB Behring LLC | NULL | Not Recruiting | Female: yes Male: yes | 30 | Austria;Sweden | |||
| 3 | NCT00168090 (ClinicalTrials.gov) | October 2001 | 12/9/2005 | Study of Safety and Efficacy of Antihemophilic Factor/Von Willebrand Factor Complex in Surgical Subjects With Von Willebrand Disease (vWD) | Study of Safety and Efficacy of Antihemophilic Factor/Von Willebrand Factor Complex (Humate-P®) Using Individualized Dosing in Pediatric and Adult Surgical Subjects With Von Willebrand's Disease. | Von Willebrand Disease;Blood Coagulation Disorders;Blood Platelet Disorders;Hematologic Disease | Drug: Blood coagulation Factor VIII and vWF, human | CSL Behring | NULL | Completed | N/A | N/A | Both | 30 | Phase 4 | United States |