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A Multinational, Open-Label, Non-Controlled Trial on Safety, Efficacy and Pharmacokinetics of NNC 0129-0000-1003 in Previously Treated Paediatric Patients With Severe Haemophilia A

2014-08-27 04:00:36 | BioPortfolio

Summary

This trial is conducted globally. The aim of the trial is to investigate safety, efficacy and pharmacokinetics (the exposure of the trial drug in the body) of NNC 0129-0000-1003 (N8-GP) in children with severe haemophilia A who have undergone treatment with previous factor VIII (FVIII) products.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Congenital Bleeding Disorder

Intervention

NNC 0129-0000-1003

Location

Novo Nordisk Clinical Trial Call Center
Phoenix
Arizona
United States
85016-7710

Status

Active, not recruiting

Source

Novo Nordisk A/S

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T04:00:36-0400

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PubMed Articles [6536 Associated PubMed Articles listed on BioPortfolio]

The Impact of Bleeding Disorders on the Socioeconomic Status of Adult Patients.

The impact of inherited bleeding disorders on the socioeconomic status (SES) of affected individuals is not clear. The SES of adult patients with congenital bleeding disorders (PWBD) from a centre in ...

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Congenital dysfibrinogenaemia assessed by whole blood thromboelastography.

Congenital dysfibrinogenaemia (CD) is a rare hereditary blood disorder, and thromboelastography (TEG) can comprehensively assess the clotting function of patients. However, only few studies have focus...

Medical and Biotech [MESH] Definitions

A congenital bleeding disorder with prolonged bleeding time, absence of aggregation of platelets in response to most agents, especially ADP, and impaired or absent clot retraction. Platelet membranes are deficient in or have a defect in the glycoprotein IIb-IIIa complex (PLATELET GLYCOPROTEIN GPIIB-IIIA COMPLEX).

Bleeding from blood vessels in the UTERUS, sometimes manifested as vaginal bleeding.

A familial coagulation disorder characterized by a prolonged bleeding time, unusually large platelets, and impaired prothrombin consumption.

Agents acting to arrest the flow of blood. Absorbable hemostatics arrest bleeding either by the formation of an artificial clot or by providing a mechanical matrix that facilitates clotting when applied directly to the bleeding surface. These agents function more at the capillary level and are not effective at stemming arterial or venous bleeding under any significant intravascular pressure.

Abnormal uterine bleeding that is not related to MENSTRUATION, usually in females without regular MENSTRUAL CYCLE. The irregular and unpredictable bleeding usually comes from a dysfunctional ENDOMETRIUM.

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