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Study of the Efficacy and Safety PF-06741086 in Adult and Teenage Participants With Severe Hemophilia A or Moderately Severe to Severe Hemophilia B
Sponsor: Pfizer
Summary
Treatment with PF-06741086 is anticipated to demonstrate a clinically relevant advantage and/or a major contribution to patient care in comparison to current methods of treatment for hemophilia A or B because it works differently than factor replacement products and will work in the presence of inhibitors. The potential for once weekly (QW) subcutaneous (SC) administration provides for treatment options in the absence of reliable vascular access, increased convenience and may enable better compliance. Combined, these qualities should result in a reduction of bleeding episodes.
Official title: An Open-Label Study in Adolescent and Adult Severe (Coagulation Factor Activity <1%) Hemophilia A Participants With or Without Inhibitors or Moderately Severe to Severe Hemophilia B Participants (Coagulation Factor Activity ≤2%) With or Without Inhibitors Comparing Standard Treatment to PF-06741086 Prophylaxis
Key Details
Gender
MALE
Age Range
12 Years - 74 Years
Study Type
INTERVENTIONAL
Enrollment
188
Start Date
2020-03-09
Completion Date
2025-04-29
Last Updated
2026-08-14
Healthy Volunteers
No
Conditions
Interventions
PF-06741086
300 milligrams(mg) subcutaneous (sc) loading dose followed by 150 mg sq once weekly (qw). 300 mg sc qw is prescribed for participants who meet dose escalation criteria.
Locations (62)
USF Health Morsani Center For Advanced Healthcare
Tampa, Florida, United States
University of Iowa
Iowa City, Iowa, United States
Northwell Health HTC
New Hyde Park, New York, United States
Washington Institute for Coagulation
Seattle, Washington, United States
National Specialized Hospital for the Active Treatment of Hematological Diseases - EAD, Sofia
Sofia, Bulgaria
UMHAT "Prof.Dr. Stoyan Kirkovich"
Stara Zagora, Bulgaria
McMaster University Medical Centre - Hamilton Health Sciences
Hamilton, Ontario, Canada
McMaster Children's Hospital
Hamilton, Ontario, Canada
McMaster University
Hamilton, Ontario, Canada
The Hospital For Sick Children
Toronto, Ontario, Canada
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China
The Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou, China
Jiangxi Provincial People's Hospital
Nanchang, Jiangxi, China
Institute of Hematology, Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, China
Beijing Children's Hospital, Capital Medical University
Beijing, China
Klinicki bolnicki centar Zagreb
Zagreb, Croatia
Hôpital Necker Enfants Malades
Paris, France
Prince of Wales Hospital
Hong Kong, Hong Kong
Queen Mary Hospital
Hong Kong, Hong Kong
Nirmal Hospital Pvt, Ltd
Surat, Gujarat, India
Sahyadri Clinical Research and Development Center
Pune, Maharashtra, India
Sahyadri Super Speciality Hospital
Pune, Maharashtra, India
Christian Medical College
Vellore, Tamil Nadu, India
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
Milan, Milan, Italy
Università degli Studi di Roma "Sapienza"-Policlinico Umberto I
Roma, RM, Italy
Università degli Studi di Perugia, Azienda Ospedaliera di Perugia, Ospedale Santa Maria della
Perugia, Italy
Nagoya University Hospital - Transfusion Medicine
Nagoya, Aichi-ken, Japan
Sapporo Tokushukai Hospital
Sapporo, Hokkaido, Japan
Saitama Medical University Hospital
Iruma-gun, Saitama, Japan
Hiroshima University Hospital
Hiroshima, Japan
Hospital Universitario "Dr Jose Eleuterio Gonzalez"
Monterrey, Nuevo León, Mexico
Centro Multidisciplinario para el Desarrollo Especializado de la Inv. Clínica en Yucatán, S.C.P.
Mérida, Yucatán, Mexico
Sultan Qaboos University Hospital
Muscat, Oman
FGBOU VO "Samara State Medical University" of MoH of Russia
Samara, Russia
King Abdulaziz University Hospital
Jeddah, Saudi Arabia
King Faisal Specialist Hospital & Research Center
Riyadh, Saudi Arabia
Clinical Center of Serbia
Belgrade, Serbia
Institute for Mother and Child healthcare "Dr Vukan Cupic"
Belgrade, Serbia
Clinical Center Kragujevac
Kragujevac, Serbia
Clinical Center Nis
Niš, Serbia
Charlotte Maxeke Johannesburg Academic Hospital
Johannesburg, Gauteng, South Africa
Kyungpook National University Hospital
Daegu, South Korea
Severance Hospital, Yonsei University Health System
Seoul, South Korea
Kyung Hee University Hospital At Gangdong
Seoul, South Korea
Hospital Universitario A Coruna
A Coruña, Spain
Hospital Universitario Vall d´Hebron
Barcelona, Spain
Hospital Universitario La Paz
Madrid, Spain
Hospital Universitario de Salamanca
Salamanca, Spain
Hospital Universitario Miguel Servet
Zaragoza, Spain
ChangHua Christian Hospital
Changhua, Changhua County, Taiwan
Taichung Veterans General Hospital
Taichung, Taiwan
Acibadem Adana Hospital
Adana, Turkey (Türkiye)
Hacettepe University Medical Faculty
Ankara, Turkey (Türkiye)
Gazi University Health Research and Practice Center Gazi Hospital
Ankara, Turkey (Türkiye)
Akdeniz University Medical Faculty
Antalya, Turkey (Türkiye)
Gaziantep University Sahinbey Research and Training Hospital
Gaziantep, Turkey (Türkiye)
Istanbul University Oncology Institute
Istanbul, Turkey (Türkiye)
Ege University Medical Faculty
Izmir, Turkey (Türkiye)
Dr. Behcet Uz Child Diseases Surgery Education and Research Hospital
Izmir, Turkey (Türkiye)
Erciyes University Medical Faculty
Kayseri, Turkey (Türkiye)
Ondokuz Mayıs University Medical Faculty
Samsun, Turkey (Türkiye)
Karadeniz Technical University Medical Faculty
Trabzon, Turkey (Türkiye)