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Hemorrhagic Disorders clinical trials

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NCT ID: NCT01787552 Completed - Clinical trials for Hematologic Diseases

A Phase Ib/II Dose-finding Study to Assess the Safety and Efficacy of LDE225 + INC424 in Patients With MF

Start date: May 8, 2013
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this phase Ib/II clinical trial was to: a) evaluate the safety of the co-administration of LDE225 and INC424 in myelofibrosis patients and establish a maximum tolerated dose and/or Recommended Phase II dose of the combination and b) to assess the efficacy of the co-administration of LDE225 and INC424 on spleen volume reduction.

NCT ID: NCT01561417 Completed - Healthy Clinical Trials

Bioequivalence of NovoSeven® and a NovoSeven® Formulation Stable at Room Temperature in Healthy Male Subjects

Start date: April 2006
Phase: Phase 1
Study type: Interventional

This trial is conducted in Europe. The aim of this trial is to demonstrate bio-equivalence between the marketed activated recombinant human factor VII (NovoSeven®) (CP-rFVIIa) and a new formulation stable at 25°C (VII25).

NCT ID: NCT01261936 Recruiting - Clinical trials for Von Willebrand Disease

Evaluation of Menses in Congenital Bleeding Disorders

MEVA-3
Start date: February 2010
Phase: N/A
Study type: Observational

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 each cycle has also been confirmed in our preliminary study on 87 healthy women. The quantitative determination of menstrual blood losses is nevertheless rarely performed, only in research settings. Although menorrhagia is a quite frequent symptom in healthy women apparently haemostatically competent in the fertile age (20-30%), its incidence becomes very high in women affected by congenital coagulation factors deficiency and (50-62.9%) inherited platelet defects, e.g. Glanzmann's Thromboasthenia (GT); also in von Willebrand Disease the bleeding symptom "menorrhagia" has an high prevalence (60-75%)(8); for GT an incidence of 90% has been reported. This explains the need for a study focused on the evaluation of menorrhagia in CBDs, addressed to answer to the following, still unsolved questions: 1. Definition of the entity of menstrual blood losses in women affected by CBDs 2. Elaboration of specific treatment schedules for each type of CBD 3. Impact of different specific treatment schedules on kinetic and entity of menstrual losses (how does treatment modify losses?).

NCT ID: NCT00697320 Completed - Clinical trials for Congenital Bleeding Disorder

Observational Study on the Efficacy and Safety of NovoSeven® During "Real-life" Usage in Germany

WIRK
Start date: June 2008
Phase: N/A
Study type: Observational

This NON INTERVENTIONAL OBSERVATIONAL STUDY is conducted in Europe. The primary aim is to observe the haemostatic efficacy of NovoSeven® treatment during routine practice in German clinics. The observational study observes patients with congenital haemophilia with inhibitors to coagulation factors VIII or IX, acquired haemophilia, congenital FVII deficiency, or Glanzmann's thrombasthenia who have received at least one dose of NovoSeven® for treatment of a bleeding episode or for the prevention of a bleeding when undergoing surgery or an invasive procedure.

NCT ID: NCT00000582 Completed - Hemophilia A Clinical Trials

Cooperative Study of Factor VIII Inhibitors

Start date: July 1978
Phase: Phase 3
Study type: Interventional

To test the efficacy of prothrombin complex concentrates (Factor IX) in the treatment of hemophiliac patients who had inhibitors to Factor VIII.