{ "data": { "asOf": "2026-10-30T22:26:12.785Z", "dedupMethod": "exact cross-registry identifier matching; probabilistic = review only", "byRegistry": { "clinicaltrials_gov": 1 }, "canonicalTrial": { "canonicalId": "NCT05145127", "title": "Open-Label Extension Study of Marstacimab in Hemophilia Participants With or Without Inhibitors", "scientificTitle": "AN OPEN-LABEL EXTENSION STUDY TO EVALUATE THE LONG-TERM SAFETY, TOLERABILITY, AND EFFICACY OF MARSTACIMAB PROPHYLAXIS IN 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", "status": "recruiting", "studyType": "interventional", "phase": [ "PHASE3" ], "conditions": [ "Hemophilia A", "Hemophilia B" ], "interventions": [ { "name": "PF-06741086", "type": "DRUG", "description": "For participants aged ≥12 years 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.\n\nFor participants aged ≥6 to \\<12 years is marstacimab 150 mg SC for initial loading dose followed by 75 mg SC QW. 150 mg sc qw is prescribed for participants who meet dose escalation criteria." } ], "sponsor": { "name": "Pfizer", "type": "INDUSTRY" }, "locations": [ { "city": "Iowa City", "country": "United States", "facility": "University of Iowa" }, { "city": "New Hyde Park", "country": "United States", "facility": "Northwell Health HTC" }, { "city": "Philadelphia", "country": "United States", "facility": "The Feinstein Institutes for Medical Research" }, { "city": "Seattle", "country": "United States", "facility": "Washington Institute for Coagulation d/b/a WACBD" }, { "city": "Mendoza", "country": "Argentina", "facility": "Arbesu Hematología" }, { "city": "Melbourne", "country": "Australia", "facility": "Royal Children's Hospital" }, { "city": "Vitória", "country": "Brazil", "facility": "HEMOES" }, { "city": "Edmonton", "country": "Canada", "facility": "Stollery Children's Hospital" }, { "city": "Hamilton", "country": "Canada", "facility": "Hamilton Health Sciences - McMaster University Medical Centre" }, { "city": "Hamilton", "country": "Canada", "facility": "Hamilton Health Sciences - McMaster University Medical Centre" }, { "city": "Guangzhou", "country": "China", "facility": "Nanfang Hospital, Southern Medical University" }, { "city": "Guiyang", "country": "China", "facility": "The Affiliated Hospital of Guizhou Medical University" }, { "city": "Wuhan", "country": "China", "facility": "Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology" }, { "city": "Nanchang", "country": "China", "facility": "Jiangxi Provincial People's Hospital" }, { "city": "Nanchang", "country": "China", "facility": "Jiangxi Provincial People's Hospital" }, { "city": "Tianjin", "country": "China", "facility": "Institute of hematology&blood disease hospital" }, { "city": "Beijing", "country": "China", "facility": "Beijing Children's Hospital, Capital Medical University" }, { "city": "Zagreb", "country": "Croatia", "facility": "Klinicki bolnicki centar Zagreb" }, { "city": "Aarhus", "country": "Denmark", "facility": "Aarhus Universitetshospital, Skejby" }, { "city": "Paris", "country": "France", "facility": "Hôpital Universitaire Necker Enfants Malades" }, { "city": "Hong Kong", "country": "Hong Kong", "facility": "The University of Hong Kong (HKU)-Queen Mary Hospital (QMH)" }, { "city": "Hong Kong", "country": "Hong Kong", "facility": "Prince of Wales Hospital" }, { "city": "Hong Kong", "country": "Hong Kong", "facility": "Queen Mary Hospital" }, { "city": "Ma Liu Shui", "country": "Hong Kong", "facility": "The Chinese University of Hong Kong" }, { "city": "Surat", "country": "India", "facility": "Nirmal Hospital Pvt Ltd." }, { "city": "Mumbai", "country": "India", "facility": "K.J Somaiya Hospital & Research Centre, Somaiya Ayurvihar Complex" }, { "city": "Pune", "country": "India", "facility": "Sahyadri Super Speciality Hospital" }, { "city": "Kolkata", "country": "India", "facility": "Nil Ratan Sircar Medical College and Hospital" }, { "city": "Ramat Gan", "country": "Israel", "facility": "Sheba Medical Center" }, { "city": "Genoa", "country": "Italy", "facility": "IRCCS Istituto Giannina Gaslini" }, { "city": "Rozzano", "country": "Italy", "facility": "Istituto Clinico Humanitas" }, { "city": "Roma", "country": "Italy", "facility": "AOU Policlinico Umberto I" }, { "city": "Milan", "country": "Italy", "facility": "Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico" }, { "city": "Nagoya", "country": "Japan", "facility": "Nagoya University Hospital - Transfusion Medicine" }, { "city": "Azumino", "country": "Japan", "facility": "Nagano Children's Hospital" }, { "city": "Kashihara", "country": "Japan", "facility": "Nara Medical University Hospital" }, { "city": "Lruma-gun", "country": "Japan", "facility": "Saitama Medical University Hospital" }, { "city": "Saitama-shi", "country": "Japan", "facility": "Saitama Children's Medical Center" }, { "city": "Hiroshima", "country": "Japan", "facility": "Hiroshima University Hospital" }, { "city": "Saga", "country": "Japan", "facility": "Saga University Hospital" }, { "city": "Mérida", "country": "Mexico", "facility": "Centro Multidisciplinario para el Desarrollo Especializado de la Investigacion Clinica en Yucatán S." }, { "city": "Muscat", "country": "Oman", "facility": "Sultan Qaboos University Hospital" }, { "city": "Belgrade", "country": "Serbia", "facility": "Clinical Center of Serbia" }, { "city": "Belgrade", "country": "Serbia", "facility": "Institute for Mother and Child healthcare \"Dr Vukan Cupic\"" }, { "city": "Niš", "country": "Serbia", "facility": "Clinical Center Nis" }, { "city": "Niš", "country": "Serbia", "facility": "Clinical Center Nis" }, { "city": "Košice", "country": "Slovakia", "facility": "Detska fakultna nemocnica Kosice" }, { "city": "Martin", "country": "Slovakia", "facility": "Univerzitna nemocnica Martin" }, { "city": "Benoni", "country": "South Africa", "facility": "Worthwhile Clinical Trials" }, { "city": "Johannesburg", "country": "South Africa", "facility": "Charlotte Maxeke Johannesburg Academic Hospital" }, { "city": "Johannesburg", "country": "South Africa", "facility": "WITS Health Consortium" }, { "city": "Seoul", "country": "South Korea", "facility": "Kyung Hee University Hospital at Gangdong" }, { "city": "Seoul", "country": "South Korea", "facility": "Severance Hospital, Yonsei University Health System" }, { "city": "Daegu", "country": "South Korea", "facility": "Kyungpook National University Hospital" }, { "city": "A Coruña", "country": "Spain", "facility": "Hospital Universitario A Coruna" }, { "city": "Barcelona", "country": "Spain", "facility": "Hospital Universitario Vall d´Hebron" }, { "city": "Madrid", "country": "Spain", "facility": "Hospital Universitario La Paz" }, { "city": "Zaragoza", "country": "Spain", "facility": "Hospital Universitario Miguel Servet" }, { "city": "Changhua", "country": "Taiwan", "facility": "ChangHua Christian Hospital" }, { "city": "Taichung", "country": "Taiwan", "facility": "Taichung Veterans General Hospital" }, { "city": "Taipei", "country": "Taiwan", "facility": "National Taiwan University Hospital" }, { "city": "Adana", "country": "Turkey (Türkiye)", "facility": "Acibadem Adana Hospital" }, { "city": "Ankara", "country": "Turkey (Türkiye)", "facility": "Hacettepe University Faculty of Medicine" }, { "city": "Ankara", "country": "Turkey (Türkiye)", "facility": "Hacettepe University Medical Faculty Hospital" }, { "city": "Ankara", "country": "Turkey (Türkiye)", "facility": "Gazi University Medical Faculty" }, { "city": "Ankara", "country": "Turkey (Türkiye)", "facility": "Gazi University Health Research and Application Center Gazi Hospital" }, { "city": "Gaziantep", "country": "Turkey (Türkiye)", "facility": "Gaziantep University Şahinbey Research and Practice Hospital" }, { "city": "Istanbul", "country": "Turkey (Türkiye)", "facility": "Istanbul University Oncology Institute" }, { "city": "Istanbul", "country": "Turkey (Türkiye)", "facility": "Istanbul Universitesi Klinik Arastirmalar Mukemmeliyet Uygulama ve Arastirma Merkezi" }, { "city": "Izmir", "country": "Turkey (Türkiye)", "facility": "Ege University Faculty of Medicine" }, { "city": "Izmir", "country": "Turkey (Türkiye)", "facility": "Ege University Faculty of Medicine" }, { "city": "Kayseri", "country": "Turkey (Türkiye)", "facility": "Erciyes University Faculty of Medicine" }, { "city": "Samsun", "country": "Turkey (Türkiye)", "facility": "Ondokuz Mayıs University Healthcare Practice and Research Center" }, { "city": "Samsun", "country": "Turkey (Türkiye)", "facility": "Ondokuz Mayıs University Medical Faculty Local Laboratory" }, { "city": "Newcastle upon Tyne", "country": "United Kingdom", "facility": "Royal Victoria Infirmary" }, { "city": "London", "country": "United Kingdom", "facility": "Guy's & St Thomas' NHS Foundation Trust" }, { "city": "Birmingham", "country": "United Kingdom", "facility": "Birmingham Children's Hospital" }, { "city": "London", "country": "United Kingdom", "facility": "Guy's & St Thomas' NHS Foundation Trust, St Thomas' Hospital" } ], "outcomes": { "other": [], "primary": [ "Number of subject reporting Adverse Events", "Number of subjects reporting Serious Adverse Events", "Incidence and severity of thrombotic events", "Incidence and severity of thrombotic microangiopathy", "Number of subjects reporting Disseminated intravascular coagulalopathy/consumption coagulopathy", "Incidence of clinically significant persistent NAb against marstacimab", "Incidence and severity of injection site reaction", "Clinically significant changes in vital signs from baseline", "Incidence of clinically significant laboratory value abnormalities", "Incidence of severe hypersensitivity and anaphylactic reactions" ], "secondary": [ "Annualized rate of bleeding episodes", "Total coagulation factor product consumption", "Incidence of joint bleeds", "Incidence of spontaneous bleeds", "Incidence of target joint bleeds", "Incidence of total bleeds (treated and untreated)", "Change in joints measured by the HJHS", "Change in number of target joints per subject from baseline", "Changes in Health Utilities Measure questionnaire data", "Changes in Haem-A-QoL questionnaire data for participants ≥17 years of age", "Changes in Haemo-QoL questionnaire data", "Total bypass product consumption", "Changes in EQ-5D questionnaire data" ] }, "eligibility": { "sex": "MALE", "criteria": "Inclusion Criteria:\n\n* All participants will have a minimum body weight as defined by parent studies\n* Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures.\n* Participants have successfully completed participation in parent studies, defined as did not require \"Early Termination\"\n\nExclusion Criteria:\n\n* Previous or current treatment for or history of coronary artery disease, venous or arterial thrombosis (CTCAE Grade \\>3), or ischemic disease (except catheter-associated thrombosis)\n* Abnormal renal function as defined by eGFR \\<30 mL.min/1.73 m(2)\n* Known planned surgical procedure during the planned study period\n* Unstable hepatic function as determined by the Investigator clinical assessment and review of the participant's most recent laboratory results, which would make the participant inappropriate for the study\n* For participants known to be HIV+, worsening disease status as determined by the Investigator clinical assessment and review of participant's most recent laboratory results, to include recent locally available CD4 count (if available), which would make the participant inappropriate for the study\n* Regular, concomitant therapy with immunomodulatory drugs (eg, IVIG, and routine systemic corticosteroids, rituximab)\n* Ongoing or planned use of immune tolerance induction or prophylaxis with FVIII or FIX replacement during the study\n* Participation in other study involving investigational drug(s) or investigational vaccine(s) within 30 days or 5 half-lives prior to or during study participation, with the exception of participation in parent studies\n* Investigator site staff or Pfizer employees directly involved in the conduct of the study, site staff otherwise supervised by the Investigator, and their respective family members", "maximumAge": "74 Years", "minimumAge": "1 Year", "healthyVolunteers": false }, "enrollment": { "type": "ESTIMATED", "count": 245 }, "startDate": "2021-11-17", "completionDate": "2030-07-31", "lastUpdated": "2026-10-26T00:00:00.000Z", "firstPosted": "2021-12-06T00:00:00.000Z", "resultsAvailable": false, "sourceRegistries": [ "clinicaltrials_gov" ], "sourceUrls": [ "https://clinicaltrials.gov/study/NCT05145127" ] }, "identifiers": [ { 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