This study is to test whether the study drug (OBI-1) is safe and effective for the treatment
of serious bleeding episodes in people with acquired hemophilia A.
Inclusion Criteria:
- Males or females ≥18 years of age.
- Written informed consent from subject.
- Subjects with acquired hemophilia with autoimmune inhibitory antibodies to human
factor VIII
- Has a serious bleeding episode, as documented by the investigator.
- Be willing and able to follow all instructions and attend all study visits.
- Subjects taking anti-thrombotics may be included depending on time elapsed since
taking such medications
- Life expectancy, before bleed, of at least 90 days.
Exclusion Criteria:
- Hemodynamically unstable
- Has an established reason for bleeding that is not correctable.
- Bleeding episode assessed likely to resolve on its own if left untreated.
- Anti-OBI-1 inhibitor that exceeds 20 BU
- Prior history of bleeding disorder other than acquired hemophilia.
- Known major sensitivity to pig or hamster products.
- Use of hemophilia medication within 3 to 6 (depending on medication) hours prior to
OBI-1 administration
- Participation in any other clinical study within 30 days of the first OBI-1
treatment.
- Anticipated need for treatment or device during the study that may interfere with the
evaluation
- Is currently pregnant or planning to become pregnant or father a child during the
study
- Abnormal baseline findings
- Inability or unwillingness to comply with the study design, protocol requirements, or
the follow-up procedures.
Hopital Cardiologique Laboratoire d' hematologie, Lille 59000, France; Not yet recruiting
Kerry Biron, Phone: 401-651-8504, Email: kbiron@inspirationbio.com
Jenny Goudeman, M.D., Principal Investigator
CHU Cochin, Haemophilia treatment center, Paris 75014, France; Not yet recruiting
Kerry Biron, Phone: 401-651-8504, Email: kbiron@inspirationbio.com
Matalie Stieltjes, M.D., Principal Investigator
Klinikum Bremen- Mitte, Bremen 28205, Germany; Recruiting
Kerry Biron, Phone: 401-651-8504, Email: kbiron@inspirationbio.com
Gunter Auerswald, M.D., Principal Investigator
National Hemophilia Centre and Haemostatis Dept State Health Center, Budapest 1134, Hungary; Recruiting
Kerry Biron, Phone: 401-651-8504, Email: kbiron@inspirationbio.com
Lazlo Nemes, M.D., Principal Investigator
Malmo University Hospital- Malmo Centre of Thrombosis and Haemostasis, Malmo, Sweden; Recruiting
Kerry Biron, Phone: 401-651-8504, Email: kbiron@inspirationbio.com
Jan Astermark, M.D., Principal Investigator
Cambridge Haemophilia Centre, Cambridge CB2 2QQ, United Kingdom; Recruiting
Kerry Biron, Phone: 401-651-8504, Email: kbiron@inspirationbio.com
David Perry, M.D., Principal Investigator
Centre for Haemostasis and Thrombosis, Guy's and St. Thomas' Hospital, London SE1 7EH, United Kingdom; Recruiting
Kerry Biron, Phone: 401-651-8504, Email: kbiron@inspirationbio.com
Bella Madan, MD, Principal Investigator
CHU Bicetre Haemopilia Treatment Centre, Kremlin-Bicetre, Cedex 94275, France; Not yet recruiting
Kerry Biron, Phone: 401-651-8504, Email: kbiron@inspirationbio.com
Thierry Lambert, M.D., Principal Investigator
Centre Regional de Traitement de l'Hemophilie, Lyon, Cedex 03 69437, France; Not yet recruiting
Kerry Biron, Phone: 401-651-8504, Email: kbiron@inspirationbio.com
Claude Negrier, M.D., Principal Investigator
Royal Free Hospital-Katharine Dormandy Haemophilia Centre and Thrombosis Unit, London, England NW3 2QG, United Kingdom; Recruiting
Kerry Biron, Phone: 401-651-8504, Email: kbiron@inspirationbio.com
Pratima Chowdary, MD, Principal Investigator
Manchester Royal Infirmary, Manchester, England M13 9WL, United Kingdom; Not yet recruiting
Kerry Biron, Phone: 401-651-8504, Email: kbiron@inspirationbio.com
Charles Hay, M.D., Principal Investigator
Emory University, Atlanta, Georgia 30322, United States; Recruiting
Denise Gannon, Phone: 910-332-2041, Email: dgannon@inclinix.com
Christine Kempton, MD, Principal Investigator
Basingstoke and North Hampshire NHS Foundation Trust, Basingstoke, Hampshire/England RG249NA, United Kingdom; Recruiting
Kerry Biron, Phone: 401-651-8504, Email: kbiron@inspirationbio.com
Savita Rangarajan, M.D., Principal Investigator
The Medicity, Gurgaon, Haryana 122001, India; Recruiting
Nidhi Mehta, Phone: +91 8802334636, Email: nidhi.mehta@medanta.org
Ashok Kumar, MD, Principal Investigator
Indiana Hemophilia and Thrombosis Center, Indianapolis, Indiana 46260, United States; Recruiting
Denise M Gannon, Phone: 910-332-2041, Email: dgannon@inclinix.com
Ann Greist, M.D., Principal Investigator
Amrita Institute of Medical Sciences & Research Centre, Kochi, Kerala, India; Recruiting
Bhagya Bharathan, Phone: +91 9961169900, Email: bhagyabharathan@aims.amrita.edu
Raghuveer Prabhu, MD, Principal Investigator
Louisiana Center for Bleeding & Clotting Disorders, New Orleans, Louisiana 70112-2699, United States; Recruiting
Denise M Gannon, Phone: 910-332-2041, Email: dgannon@inclinix.com
Rebecca Kruse-Jarres, M.D., Principal Investigator
A Bianchi Bonomi Hemophlia and Thrombosis Centre, Insistitute of Internal Medicine, IRCCS Ospedale Maggoire, Milan, MI 20122ªO, Italy; Recruiting
Kerry Biron, Phone: 401-651-8504, Email: kbiron@inspirationbio.com
Elena Santagostino, M.D., Principal Investigator
Deenanth Mangeshkar Hospital & Research Centre, Pune, Maharashtra, India; Recruiting
Nutan Gangurde, Phone: +919822279086, Email: yashashresabare@gmail.com
Melinkeri, MD, Principal Investigator
Tufts Medical Center, Boston, Massachusetts 02111, United States; Recruiting
Denise Gannon, Phone: 910-332-2041, Email: dgannon@inclinix.com
Hedy Smith, MD, Principal Investigator
Brigham and Women's Hospital, Boston, Massachusetts 02115, United States; Recruiting
Denise Gannon, Phone: 910-332-2041, Email: dgannon@inclinix.com
Judith Lin, MD, Principal Investigator
University of North Carolina at Chapel Hill Hospital, Chapel Hill, North Carolina 27599-7305, United States; Active, not recruiting
Churchill Hospital--Oxford Haemophilia Centre and Thrombosis Unit, Headington, Oxford/England OX3 7LJ, United Kingdom; Recruiting
Kerry Biron, Phone: 401-651-8504, Email: kbiron@inspirationbio.com
Paul Giangrande, MD, Principal Investigator
The Pennsylvania State University and Milton S. Hershey Medical Center, Hershey, Pennsylvania 17033, United States; Not yet recruiting
Denise Gannon, Phone: 910-332-2041, Email: dgannon@inclinix.com
M. Elaine Eyster, MD, Principal Investigator
Maisonneuve-Rosemont Hospital, Montreal, Quebec H1T 2M4, Canada; Recruiting
Denise M Gannon, Phone: 910-332-2041, Email: dgannon@inclinix.com
Jean St-Louis, MD, Principal Investigator
Apollo Hospitals, Chennai, Tamil Nadu 600006, India; Recruiting
Hilda Solomon, MD, Phone: +91 98417 00824, Email: hilda@aherf-smo.org
Revathi Raj, MD, Principal Investigator
P. Prabu, MD, Sub-Investigator
Puget Sound Blood Center, Seattle, Washington 98104, United States; Recruiting
Denise M Gannon, Phone: 910-332-2041, Email: dgannon@inclinix.com
Barbara Konkle, MD, Principal Investigator
