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Study to Gain More Information on How Safe and Effective Jivi Works in Patients With Severe Hemophilia A (Post-marketing Investigation)

2019-09-15 03:11:36 | BioPortfolio

Summary

The goal of this study is to gather more information on how safe and well Jivi works in patients with severe hemophilia A. Jivi has been approved by various regulatory agencies, including the FDA, Health Canada, Japanese Health Authority and the European Medicinal Agency. 25 patients will be enrolled and will stay for 1 to 2 years in this study depending on their treatment frequency. Researcher will monitor during the course of the study whether patients are developing antibodies (a protein made by the body in response to the drug) affecting the effectiveness of Jivi. In addition information on bleedings and patient's wellbeing will be collected.

Study Design

Conditions

Hemophilia A

Intervention

Damoctocog alfa pegol (Jivi, BAY94-9027)

Location

UMHAT Tsaritsa Joanna-ISUL EAD Sofia
Sofia
Calabria
Bulgaria
1527

Status

Not yet recruiting

Source

Bayer

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-09-15T03:11:36-0400

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PubMed Articles [171 Associated PubMed Articles listed on BioPortfolio]

Correction to: Damoctocog Alfa Pegol: A Review in Haemophilia A.

The article Damoctocog Alfa Pegol: A Review in Haemophilia A, written by Julia Paik and Emma D. Deeks, was originally published Online First without open access.

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Medical and Biotech [MESH] Definitions

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The classic hemophilia resulting from a deficiency of factor VIII. It is an inherited disorder of blood coagulation characterized by a permanent tendency to hemorrhage.

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A recombinant alfa interferon consisting of 165 amino acid residues with arginine in position 23 and histidine in position 34. It is used extensively as an antiviral and antineoplastic agent.

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An antibody is a protein produced by the body's immune system when it detects harmful substances, called antigens. Examples of antigens include microorganisms (such as bacteria, fungi, parasites, and viruses) and chemicals. Antibodies may be produc...


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