Eptacog Beta is the first inhibitor bypassing agent approved by FDA in over 20 years. In addition to the clinical trials that helped gain FDA approval for this agent—as part of our ongoing commitment to helping people with rare bleeding disorders—we have pursued additional trials with Eptacog Beta with the goal of gaining approval for future treatment indications.
|
A Phase I Safety, Pharmacokinetics and Pharmacodynamics Study of Recombinant Factor VIIa in Adult Patients With Hemophilia A or B (rhFVIIa) |
|||
|
Official Title: A Phase 1b, Dose Escalation Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of Coagulation Factor VIIa (Recombinant) in Congenital Hemophilia A or B Patients With or Without Inhibitors Condition/disease: Hemophilia Study Phase: Phase Ib Brief Summary: This study will assess the safety, pharmacokinetics, and pharmacodynamics of rhFVIIa at three dose levels (25, 75, and 225 mcg/kg). The results will help identify the most optimal doses to take forward to the Phase 2/3 studies where bleedings in hemophilia patients with inhibitors will be treated with rhFVIIa. Interventions: Drug: rhFVIIa NCT Number: NCT01708564 |
Locations:
|
Age Range: 18 to 75 years |
Status: Completed First posted: October 17, 2012 Last update: July 30, 2013 |
|
Phase III Study of Coagulation FVIIa (Recombinant) in Congenital Hemophilia A or B Patients With Inhibitors (PERSEPT 1) PERSEPT = Program for the Evaluation of Recombinant factor Seven Efficacy by Prospective clinical Trials |
|||
|
Official Title: A Phase III Study on the Safety, Pharmacokinetics and Efficacy of Coagulation Factor VIIa (Recombinant) in Congenital Hemophilia A or B Patients With Inhibitors to Factor VIII or IX Condition/disease: Hemophilia A or B Study Phase: Phase III Brief Summary: The purpose of the study is to assess the safety, efficacy and pharmacokinetics of 2 separate dose regimens (75µg/kg and 225 µg/kg) of Coagulation Factor VIIa (Recombinant) for the treatment of bleeding episodes in hemophilia A or B patients with inhibitors to Factor VIII/IX. Interventions: Drug: Coagulation Factor VIIa (Recombinant), Crossover Assignment NCT Number: NCT02020369 |
Locations:
|
Age Range: 12 to 75 years |
Status: Completed First posted: December 24, 2013 Last update: June 14, 2017 |
|
A Phase III Study on the Safety, Pharmacokinetics and Efficacy of Coagulation Factor VIIa (PERSEPT 2) |
|||
|
Official Title: A Phase III Study on the Safety, Pharmacokinetics, and Efficacy of Coagulation Factor VIIa (Recombinant) in Congenital Hemophilia A or B Pediatric Patients From Birth to <12 Years Old With Inhibitors to Factor VIII or IX: PerSept 2 Condition/disease: Hemophilia A or B Study Phase: Phase III Brief Summary: The purpose of the study is to assess the safety, efficacy and pharmacokinetics of 2 separate dose regimens (75µg/kg and 225 µg/kg) of Coagulation Factor VIIa (Recombinant) for the treatment of bleeding episodes in hemophilia A or B patients with inhibitors to Factor VIII or IX in 12 patients (birth to <6 years old), and 12 patients (≥6 years old to <12 years old). Interventions: Drug: Coagulation Factor VIIa (Recombinant), Crossover Assignment NCT Number: NCT02448680 |
Locations:
|
Age Range: up to 11 years |
Status: Completed First posted: August 28, 2020 Last update: September 29, 2020 |
|
Eptacog Beta in Congenital Hemophilia Patients With Inhibitors Undergoing Elective Surgery or Invasive Procedures (PERSEPT 3) |
|||
|
Official Title: Phase 3 Study of Safety and Efficacy of Coagulation Factor VIIa (Recombinant) for Prevention of Excessive Bleeding in Congenital Hemophilia A/B Patients With Inhibitors to Factor VIII/IX Undergoing Elective Surgery/Other Invasive Procedures Condition/disease: Hemophilia A or B Study Phase: Phase III Brief Summary: The purpose of this study, PERSEPT 3, is to evaluate eptacog beta for the prevention of excessive bleeding and achievement of hemostasis in congenital hemophilia A or B patients who have inhibitors to Factor VIII or Factor IX , are aged 6 months to 75 years, inclusive; and who are undergoing elective surgical or other invasive procedures. Administration of eptacog beta will be performed just prior to surgery/procedure and will be repeated during and after the surgery/procedure to achieve and maintain adequate hemostasis as determined by the investigator's judgment. Interventions: Drug: Coagulation Factor VIIa (Recombinant), Single Group Assessment NCT Number: NCT02448680NCT02548143 |
Locations:
|
Age Range: 6 months to 75 years |
Status: Completed First posted: September 6, 2019 Last update: May 14, 2020 |
Sign up to learn more about our focus on the rare bleeding disorder community
 |
Melanie Comella, PHR, Senior Director, Human ResourcesMelanie is the Senior Director of Human Resources at HEMA Biologics. She brings 20 years of Human Resources and Employee Relations expertise, and holds her Professional in Human Resources certification. In her free time, Melanie enjoys spending time with her family, traveling, and is an avid sports fan. |
 |
Rebecca DeVore, Talent Acquisition SpecialistRebecca is passionate about accelerating company growth and sourcing top talent to assist in achieving company goals. Offering over 10 years of expertise in HR, Executive Search, Talent Management and Leadership Development, Rebecca has expertise in a wide variety of areas within Human Resources. Rebecca holds her Bachelor’s degree in Business/ HR Management from Indiana Wesleyan University. Outside of the office, Rebecca loves enjoying life with her husband and 2 sons, being outdoors, playing sports, and cooking. |
 |
Heather Van Camp, Accounting ManagerHeather is an experienced accounting manager with an established history of working in the healthcare industry. At HEMA Biologics, she has focused on creating a supportive accounting department for both internal and external customers. Prior to her role with HEMA Biologics, Heather spent 9 years in the accounting and finance department in the physical therapy industry. In her spare time, Heather enjoys spending time with family and friends, exercising, and reading. |
 |
Allan Alexander, MD, Senior Medical DirectorW. Allan Alexander, MD brings 26 years of experience in the care and management of clinical bleeding in rare disorders and acute illness. A Cardiac Anesthesiologist who practiced in elite hospitals, Dr Alexander’s drug and device career includes leadership roles with Thermo CardioSystems, Inc, Micromed Technologies, Inc, CEDRA Clinical Research, ZymoGenetics, Inc (a subsidiary of Novo Nordisk then BMS) and CSL Behring, USA. Dr Alexander was the first employee of HEMA Biologics, in January 2016. |
 |
Christi Marsh, PharmD, Director, Medical Affairs, Medical Information and Scientific CommunicationDr Marsh brings over 20 years of experience in clinical pharmacy, industry medical affairs work, and leadership experience at pharmaceutical companies including GlaxoSmithKline, Meditech Media, Solvay Pharmaceuticals (now Abbvie), MedInfo Results, and UCB, Inc. Dr Marsh joined HEMA Biologics in 2017 to build the Medical Affairs practice team with a focus on helping offer solutions for healthcare providers, caregivers, and patients in the rare bleeding disorders community. Dr Marsh enjoys fitness, family time, and cheering on her daughter in competitive figure skating. |
 |
Gary Grote, Vice President, Market AccessGary leads the customer interface team that has responsibility for payer and specialty channel relationships and contracting, as well as contributing to the managed markets marketing strategy for HEMA Biologics. Gary has worked in the industry for over 30 years and built the HEMA Biologic’s Market Access team. Gary is a fan of the Cincinnati Reds and Bengals and the Ohio State Buckeyes. He resides in Ohio with his wife, Cathy, and enjoys traveling, fishing, golf, fine wines, and Kentucky’s great bourbons. |
 |
Brandon King, Director of MarketingBrandon is focused on commercializing innovative therapy options for the bleeding disorder community through HEMA Biologics. He has over 15 years of experience in pharmaceutical marketing, business development, sales, and brand management. Prior to HEMA Biologics, Brandon was in sales and brand management at Procter and Gamble Pharmaceuticals. In his spare time, Brandon loves spending time with his family and friends and traveling to new places. |
 |
Kate Nyormoi, MA, Associate Director of MarketingKate has a passion for engaging with the bleeding disorder community and developing resources that positively impact the lives of individuals affected by rare bleeding disorders. Prior to HEMA Biologics, she spent 10 years working for Eli Lilly and Company, with the majority of that time in oncology. In her free time, Kate loves spending time outside with her husband, son, and four-legged child. |
 |
Elyse Bergeron, Consumer Brand ManagerAs a consumer brand manager at HEMA Biologics, Elyse is responsible for consumer marketing initiatives. Prior to HEMA Biologics, she spent 4 years creating and marketing consumer programs and services for the rare bleeding disorder community at Shire. Elyse earned a B.S. in Life Sciences Communication from the University of Wisconsin. In her spare time Elyse enjoys spending time with family, cooking, and reading. |
 |
Darcie Spaulding, Marketing Project ManagerDarcie attended Florida State University and practiced marketing in New York City before she moved back to her hometown of Louisville, KY. For HEMA Biologics, Darcie manages commercial marketing efforts, including media and advertising, promotional materials, and conference/symposia initiatives and execution. She loves spending time with friends and family, hiking with her dog Bailey, and any excuse to escape to the beach. |
 |
Blake Buckman, Social Media CoordinatorAs Social Media Coordinator, Blake is always in search of new ways to connect with the community in the digital space. He is a recent graduate of the University of Kentucky where he earned his Bachelor’s Degree in Kinesiology. In his spare time, Blake enjoys playing his guitar, listening to music, and spending time with his friends. For links to all HEMA Biologics Social Media accounts, check the bottom of the page! |
 |
Vince Poma, National Sales DirectorVince is the National Sales Director for HEMA Biologics and has over 20 years’ experience in healthcare in various specialties, including cardiovascular, neurology, hematology, and immunology. He is particularly passionate about the hemophilia community and building lasting and meaningful relationships. He has been with HEMA Biologics since its beginning and is enthusiastic about building a company that has winners (products, people, culture, leadership, and vision). Vince has a degree in Finance from Clemson University and lives in Louisville, KY, with his wife, son, and daughter. He enjoys watching his kids compete in athletics and is a Clemson Football Fanatic. |
