TORONTO, June 25, 2018 (GLOBE NEWSWIRE) -- Octapharma announced today the launch of the Canadian PREVAIL (Immune Tolerance Induction in Hemophilia A Patients using Wilate®) study for patients with Hemophilia A. The PREVAIL study will enroll hemophilia A patients who have recently developed inhibitors to a FVIII concentrate or who have had long-standing inhibitors to FVIII. Immune tolerance induction (ITI) is the only method of eradicating the inhibitor, and even patients with long standing inhibitors may be able to reduce reliance on bypassing agents for their treatment. The aim of PREVAIL is to better understand patient and therapy related variables on the course and outcome of ITI in a Canadian setting.



According to the coordinating investigators, Dr. Paul Moorehead from the Janeway Children’s Health and Rehabilitation Centre in St. John’s and Dr. Mark Belletrutti from Stollery Children’s Hospital in Edmonton, inhibitor development is the most serious complication of hemophilia A treatment today, occurring in up to 30-40 percent of newly treated patients with severe hemophilia A. “The presence of a FVIII inhibitor in the body will rapidly inactivate the infused factor VIII concentrate, thus making bleed control and prevention of joint damage a clinical challenge in these patients. ITI can result in inhibitor resolution, but can take several years to succeed“, said Dr. Moorehead.

“Although several treatment regimens are used routinely, optimal regimen for ITI is yet to be defined. Persons living with FVIII inhibitors have high morbidity, mortality and associated increases in cost of care and this study is an important step to improve treatment and patient outcomes in Canada”, said Dr. Belletrutti.

The PREVAIL study is the first Canadian, 10-year study of hemophilia A inhibitor patients treated with Wilate for either first occurrence of inhibitors, inhibitors refractory to previous ITI attempts, or relapsed inhibitors to FVIII. Moderate and severe hemophilia A persons of all ages living with inhibitors are eligible and patient enrolment for the study is now open. The comprehensive data collection includes ITI outcome data, bleeding rates during ITI, joint health during ITI, adherence to treatment and relapse rates. Optional sub-studies evaluate quality of life (QoL) during ITI and shed light on inhibitor biology for better inhibitor management. The PREVAIL study will complement currently available data and provide important, prospective information to support the management of patients with hemophilia A who develop inhibitors.

”Given the huge impact inhibitors can have on a person’s life and ability to manage their hemophilia, the Canadian Hemophilia Society (CHS) is supportive of studies on inhibitors and pleased to see the start of this study to collect long term ITI data in Canada to help improve approaches to treatment," said Paul Wilton, CHS President.

For additional information about the study, please contact medinfo@octapharma.ca

About Octapharma in Hemophilia

Octapharma has been dedicated to improving hemophilia care for over 30 years. Addressing the challenge of inhibitor formation in hemophilia A has been the focus of our hemophilia product development as well as our research efforts. For over a decade Octapharma has invested in inhibitor management registry studies, and in the development of recombinant VIII. Our understanding of bleeding disorders is reflected not only in our products for the treatment of hemophilia A, hemophilia B and von Willebrand disease, but also in the development of personalized treatment options. In Canada Octapharma is committed to providing new innovative treatment options and improving care for hemophilia and other bleeding disorders.

Octapharma Canada media contact: Sri Adapa: email: sri.adapa@octapharma.ca