RESEARCH TRIANGLE PARK, N.C., Oct. 4, 2013 /PRNewswire/ -- Grifols Inc., a leading manufacturer of life-saving plasma protein therapies, today announced the launch of the SPIRIT (Study of Plasma-derived factor VIII/VWF in Immune toleRance Induction Therapy) registry for patients with hemophilia A at the National Hemophilia Foundation (NHF) annual meeting in Anaheim, Calif. The SPIRIT registry will enroll U.S. patients with hemophilia A and inhibitors being treated with Grifols' plasma-derived factor VIII/VWF product, ALPHANATE® (antihemophilic factor/von Willebrand factor complex [human]).
According to the registry's lead investigator, Rebecca Kruse-Jarres, M.D., of Tulane University, this observational study fills an important void.
"There is not a lot of prospective data to help us understand how patients with inhibitors respond to treatment, especially as it relates to adherence and quality of life. The data from the SPIRIT registry will give us more information to treat our patients and should complement the ongoing RESIST study."
Dr. Kruse-Jarres will present a poster at the NHF meeting that outlines the registry design.
"The SPIRIT registry is another example of Grifols' commitment to the hemophilia community," said Eva Bastida, Ph.D., Vice President of Scientific and Medical Affairs at Grifols. "We are happy to launch this initiative and further support efforts to provide information to hemophilia treaters."
ALPHANATE® (antihemophilic factor/von Willebrand factor complex [human]) is indicated for:
- Control and prevention of bleeding in patients with hemophilia A
- Surgical and/or invasive procedures in adult and pediatric patients with von Willebrand disease (VWD) in whom desmopressin (DDAVP) is either ineffective or contraindicated. It is not indicated for patients with severe VWD (Type 3) undergoing major surgery
Important Safety Information
ALPHANATE® (antihemophilic factor/von Willebrand factor complex [human]) is contraindicated in patients who have manifested life-threatening immediate hypersensitivity reactions, including anaphylaxis, to the product or its components.
Anaphylaxis and severe hypersensitivity reactions are possible. Should symptoms occur, treatment with ALPHANATE should be discontinued, and emergency treatment should be sought.
Development of activity-neutralizing antibodies has been detected in patients receiving FVIII containing products. Development of alloantibodies to VWF in Type 3 von Willebrand Disease (VWD) patients has been occasionally reported in the literature.
Thromboembolic events may be associated with AHF/VWF Complex (Human) in VWD patients, especially in the setting of known risk factors.
Intravascular hemolysis may be associated with infusion of massive doses of AHF/VWF Complex (Human).
Rapid administration of a FVIII concentrate may result in vasomotor reactions.
Plasma products carry a risk of transmitting infectious agents, such as viruses, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent, despite steps designed to reduce this risk.
The most frequent adverse events reported with ALPHANATE® (antihemophilic factor/von Willebrand factor complex [human]) in >5% of patients are respiratory distress, pruritus, rash, urticaria, face edema, paresthesia, pain, fever, chills, joint pain, and fatigue.
Grifols is a global healthcare company with a 70-year legacy of improving people's health and well being through the development of life-saving plasma medicines, hospital pharmacy products and diagnostic technology for clinical use.
As a leading producer of plasma medicines, Grifols has a presence in more than 100 countries and is the world leader in plasma collection, with 150 plasma donation centers across the U.S. Grifols is committed to increasing patient access to its life-saving plasma medicines through significant manufacturing expansions and the development of new therapeutic applications of plasma proteins. The company is headquartered in Barcelona, Spain and employs more than 11,000 people worldwide.
In 2012, Grifols' sales exceeded 2,620 million euros. The company's class A shares are listed on the Spanish Stock Exchange, where they are part of the Ibex-35 (MCE:GRF). Its non-voting class B shares are listed on the Mercado Continuo (MCE:GRF.P) and on the U.S. NASDAQ via ADRs (NASDAQ: GRFS). For more information visit www.grifols.com
SOURCE Grifols Inc.