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Currently, you can access the following clinical trials being conducted worldwide:
Clinicaltrials.gov identifier NCT03938792
Recruitment Status Recruiting
First Posted May 6, 2019
Last update posted October 13, 2020
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.
Participants will be assigned to treatment with PF-06741086 after a 6 month Observation Phase on their current hemophilia regimen.
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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, , Learn About Clinical Studies.-->
- Participants with a diagnosis of severe hemophilia A or B with a minimum weight of 30
kg at screening.
- Participant or legally authorized representative, or participant's caregiver capable
of giving signed informed consent (or minor assent, when applicable).
Participants who are enrolled into the Non-Inhibitor Cohort must also meet the following
- No detectable or documented history of inhibitors
- Participants on FVIII/FIX routine prophylaxis who have demonstrated at least 80%
compliance with scheduled prophylaxis regimen during 6 months prior to enrollment and
are willing to continue to receive routine prophylaxis treatment with FVIII/FIX
replacement during the Observational Phase.
- Participants with on-demand treatment regimen with ≥6 acute bleeding episodes
(spontaneous or traumatic) that required coagulation factor infusion during the 6
months period prior to enrollment and willing to continue to receive on demand
treatment during the Observational Phase.
Participants who are enrolled into the Inhibitor Cohort must also meet the following
- Documentation of current high titer inhibitor (≥5 BU/mL) or current low titer
inhibitor (<5 BU/mL) refractory to FVIII or FIX replacement and with FVIII or FIX recovery <60% of expected within previous 6 months prior to enrolment into the Observational Phase - Participants with on-demand treatment regimen with ≥6 bleeding episodes (spontaneous and/or traumatic) necessitating treatment with bypass factor during the 6 months prior to enrollment in the Observation Phase and willing to continue to receive on-demand treatment during this phase. - Participants who have documented inhibitors while on factor-replacement therapy but who do not meet the quantitative inhibitor criteria described in the prior bullet at the time of Screening (eg, participant with a previously documented high-titer inhibitor (≥5 BU/mL) and whose condition precludes re-challenge with FVIII or FIX replacement) may be considered for eligibility on a case-by-case basis with prior approval from the Pfizer Medical Monitor Exclusion Criteria - Previous or current treatment for and/or history of coronary artery diseases, venous or arterial thrombosis or ischemic disease - Known planned surgical procedure during the planned study period. - Known hemostatic defect other than hemophilia A or B. - Abnormal renal or hepatic function - Current unstable liver or biliary disease - Abnormal hematologic parameters - Other acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, - Current routine prophylaxis with bypassing agent or non-coagulation non-factor- replacement therapy - Regular, concomitant therapy with immunomodulatory drugs - Ongoing or planned use of immune tolerance induction or prophylaxis with FVIII or FIX replacement during the Active Treatment Phase. - Previous exposure to PF 06741086 during to participation in studies B7841002 and B7841003. - Participation in other studies involving investigational drug(s) within 30 days (or as determined by local requirements) or 5 half-lives prior to study entry and/or during study participation. - CD4 cell count ≤200/uL if human immunodeficiency virus (HIV)-positive - Screening ECG that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results. - Individuals with hypersensitivity or an allergic reaction to hamster protein or other components of the study intervention. - Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or participants who are Pfizer employees, including their family members, directly involved in the conduct of the study.
Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com
United States, Arkansas
Arkansas Children's Hospital
United States, Florida
USF Health Morsani Center For Advanced Healthcare
United States, New York
Northwell Health HTC
New Hyde Park
University Multiprofile Hospital for Active Treatment ''Georgi Stranski'' EAD
National Specialized Hospital for the Active Treatment of Hematological Diseases - EAD, Sofia
Klinikum der Johann Wolfgang Goethe-Universität, Medizinische Klinik II,
Frankfurt am Main
Prince of Wales Hospital
Queen Mary Hospital
Nirmal Hospital Pvt, Ltd
Sahyadri Clinical Research and Development Center
Sahyadri Super Speciality Hospital
Nagoya University Hospital - Transfusion Medicine
Nara Medical University Hospital
Tokyo Metropolitan Children's Medical Center
National Center for Child Health and Development
Hiroshima University Hospital
Korea, Republic of
Kyungpook National University Hospital
Korea, Republic of
Severance Hospital, Yonsei University Health System
Korea, Republic of
Kyung Hee University Hospital at Gangdong
Sultan Qaboos University Hospital
FGBOU VO "Samara State Medical University" of MoH of Russia
Clinical Center of Serbia
Institute for Mother and Child healthcare "Dr Vukan Cupic"
Clinical Center Kragujevac
Clinical Center Nis
Institute for Child and Youth Healthcare Vojvodina
Spain, Islas Baleares
Hospital Universitario de Son Espases
Palma de Mallorca
Kaohsiung Medical University Chung-Ho Memorial Hospital
Acibadem Adana Hospital
Hacettepe University Medical Faculty
Gazi University Health Research and Practice Center Gazi Hospital
Akdeniz University Medical Faculty
Gaziantep University Sahinbey Research and Training Hospital
Istanbul University Oncology Institute
Istanbul University-Cerrahpasa, Cerrahpasa Medical Faculty
Ege University Medical Faculty
Ege University Medical Faculty
Erciyes University Medical Faculty
Ondokuz Mayıs University Medical Faculty
Karadeniz Technical University Medical Faculty
Study Director: Pfizer CT.gov Call Center Pfizer