Advertisement

Topics

Safety of 40K Pegylated Recombinant Factor IX in Non-Bleeding Patients With Haemophilia B

2014-08-27 03:20:09 | BioPortfolio

Summary

This trial is conducted in Europe, Japan and the United States of America (USA).

The aim of this clinical trial is to investigate the safety and pharmacokinetics (the determination of the concentration of the administered medication in blood over time) of Pegylated Recombinant Factor IX in Non-Bleeding Patients with Haemophilia B.

Study Design

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

Conditions

Haemophilia B

Intervention

40K PEG-rFIX, 40K PEG-rFIX, 40K PEG-rFIX

Location

Novo Nordisk Clinical Trial Call Center
Ann Arbor
Michigan
United States
48109-5235

Status

Active, not recruiting

Source

Novo Nordisk

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:20:09-0400

Clinical Trials [86 Associated Clinical Trials listed on BioPortfolio]

Study Evaluating of Recombinant Human Factor IX (BeneFIX) and a New Formulation of BeneFIX (rFIX-R) in Moderate to Severe Hemophilia B

The primary objective of this clinical research study is to establish the bioequivalence of 2 treatments, rFIX and rFIX-R, when given as a 10-minute intravenous bolus infusion.

Study Evaluating rFIX; BeneFIX in Severe Hemophilia B

To characterize the safety and efficacy of rFIX in children less than 6 years of age with severe hemophilia B in the setting of acute bleeding episodes, prophylaxis, and/or surgery. This ...

Factor Product Utilization and Health Outcomes in Patients With Hemophilia

Recombinant factor VIII Fc (rFVIIIFc) and recombinant factor IX Fc (rFIXFc) are extended half-life coagulation factors approved by Health Canada in 2014 for the treatment of severe hemophi...

Non Substitutive Strategies to Improve Haemophilia Care in Developing Countries. Experience in Ivory Coast.

This study aims to make an inventory of the condition and care of patients with haemophilia and carriers for haemophilia in Ivory Coast and to promote the use non substitutive strategies t...

Bleeding Risk Evaluation in Haemophilia Patients Under Antiplatelet Therapies

Life expectancy of haemophilia patients (specially severe) has dramatically increase in the last decades, which lead to the apparition of aging diseases such as cardiovascular disease, wit...

PubMed Articles [91 Associated PubMed Articles listed on BioPortfolio]

Screening of haemophilia carriers in moderate and severe haemophilia A and B: Prevalence and determinants.

Advancement in the treatment of haemophilia.

Poor understanding of the pathophysiological mechanisms involved in Haemophilia is a major obstacle in accessing effective haemophilia disease management. Haemophilia is a life-frightening bleeding pr...

Patient-centred value framework for haemophilia.

Growing budgetary demands have led to increased scrutiny of healthcare spending for rare diseases, leading to a unified goal within the haemophilia community to define objectively patient-centred valu...

Validation of the Haemophilia & Exercise Project-Test-Questionnaire (HEP-Test-Q)-An instrument for the assessment of subjective physical functioning in children with haemophilia.

Contemporary haemophilia management recommends sport and physical activity in children with haemophilia. Assessment of subjective physical functioning requires standardized and validated instruments.

Recurrent F8 and F9 gene variants result from a founder effect in two large French haemophilia cohorts.

Haemophilia A (HA) and haemophilia B (HB) are X-linked recessive diseases, caused by a large number of pathogenic variants in the F8 and F9 genes. With the exception of introns 22 and 1 inversions whi...

Medical and Biotech [MESH] Definitions

None available.

More From BioPortfolio on "Safety of 40K Pegylated Recombinant Factor IX in Non-Bleeding Patients With Haemophilia B"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Clincial Trials
In a clinical trial or interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or change...

Pharmacy
Pharmacy is the science and technique of preparing as well as dispensing drugs and medicines. It is a health profession that links health sciences with chemical sciences and aims to ensure the safe and effective use of pharmaceutical drugs. The scope of...


Searches Linking to this Trial