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| ID | Type | Description | Link |
|---|---|---|---|
| PHASE 3 ANTI-TFPI OLE | Other Identifier | Alias Study Number | |
| 2022-500470-33-00 | Registry Identifier | CTIS (EU) |
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Study B7841007 is an open-label extension study to assess the long-term safety, tolerability, and efficacy of prophylaxis treatment with marstacimab in participants who did not require "Early Termination" from the Phase 3 Study B7841005 and from the Phase 3 Study B7841008.
Study B7841005: approximately 145 adolescent and adult participants 12 to <75 years of age with severe hemophilia A or moderately severe to severe hemophilia B (defined as FVIII activity <1% or FIX activity ≤2%, respectively) with or without inhibitors are expected to be enrolled in Study B7841005 during which they will receive prophylaxis (defined as treatment by SC injection of marstacimab).
Study B7841008: this is an ongoing Phase 3, open-label study in pediatric participants <18 years of age with severe hemophilia A (FVIII Coagulation Factor Activity <1%) or moderately severe to severe hemophilia B (FIX Coagulation Factor Activity ≤2%). A sequential approach will be used in enrolling at least 100 pediatric participants, at least 20 of which will be aged ≥12 to <18 years and at least 80 participants will be aged ≥1 to <12 years. At the start of study B7841008, the dosing and data available in adolescent and adult participants in Study B7841005 supported the initiation of B7841008 study in participants aged ≥12 to <18 years. Subsequently, additional safety and efficacy data from adolescent participants in Study B7841005 became available for benefit/risk assessment in support of dosing participants aged ≥6 to <12 years. Based on the positive benefit/risk assessment conducted by both internal Pfizer review and eDMC review, dosing of the ≥6 to <12 years age group was initiated in June 2023 in B7841008 Study. Data from participants ≥6 years from B7841008 Study and Study B7841005 will support the dosing of participants aged ≥1 to <6 years.
All participants will be provided the prefilled pen (PFP) for administration of marstacimab in the study. Use of the prefilled syringe (PFS) will be permitted at the investigator's discretion for those participants who have difficulty with administration of the PFP. Additionally, participants will be provided the PFS for use in this study in countries where the PFS is anticipated to be the only presentation available commercially. An optional, open-label, single arm, substudy using the PFP was completed in the first 23 participants rolled over from Study B7841005 who agreed to participate in the substudy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PF-06741086 | Experimental | 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. For 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-06741086 | Drug | 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. For 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of subject reporting Adverse Events | Baseline up to 7 years | |
| Number of subjects reporting Serious Adverse Events | Baseline up to 7 years | |
| Incidence and severity of thrombotic events | Baseline up to 7 years | |
| Incidence and severity of thrombotic microangiopathy | Baseline up to 7 years | |
| Number of subjects reporting Disseminated intravascular coagulalopathy/consumption coagulopathy | Baseline up to 7 years | |
| Incidence of clinically significant persistent NAb against marstacimab | Baseline up to 7 years | |
| Incidence and severity of injection site reaction | Baseline up to 7 years | |
| Clinically significant changes in vital signs from baseline | Baseline up to 7 years | |
| Incidence of clinically significant laboratory value abnormalities | Baseline up to 7 years | |
| Incidence of severe hypersensitivity and anaphylactic reactions | Baseline up to 7 years |
| Measure | Description | Time Frame |
|---|---|---|
| Annualized rate of bleeding episodes | Derived for each subject for each treatment period by using the following formula: ABR = number of bleeds requiring treatments/ (days on treatment period / 365.25) | Baseline up to 7 years |
| Total coagulation factor product consumption |
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Inclusion Criteria:
Exclusion Criteria:
Male participants only
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pfizer CT.gov Call Center | Contact | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Iowa | Active, not recruiting | Iowa City | Iowa | 52242 | United States | |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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|
| Baseline up to 7 years |
| Incidence of joint bleeds | Baseline up to 7 years |
| Incidence of spontaneous bleeds | Baseline up to 7 years |
| Incidence of target joint bleeds | Baseline up to 7 years |
| Incidence of total bleeds (treated and untreated) | Baseline up to 7 year |
| Change in joints measured by the HJHS | Change in joints as measured by the HJHS for participants ≥4 years of age | Baseline up to 7 years |
| Change in number of target joints per subject from baseline | Baseline up to 7 years |
| Changes in Health Utilities Measure questionnaire data | Baseline up to 7 years |
| Changes in Haem-A-QoL questionnaire data for participants ≥17 years of age | Baseline up to 7 years |
| Changes in Haemo-QoL questionnaire data | Haemo-QoL CII (Ages 8 to <12 years), Haemo-QoL (Ages 12 to <17), | Baseline up to 7 years |
| Total bypass product consumption | Baseline up to 7 years |
| Changes in EQ-5D questionnaire data | EQ-5D-Y Proxy (Ages ≥ 4 to ≤ 6 years), EQ-5D-Y Self (Ages ≥ 7 to ≤ 11 years), EQ-5D-5L (Ages ≥12) | Baseline up to 7 years |
| Northwell Health HTC |
| Recruiting |
| New Hyde Park |
| New York |
| 11040 |
| United States |
| The Feinstein Institutes for Medical Research | Recruiting | Philadelphia | Pennsylvania | 19195 | United States |
| Washington Institute for Coagulation d/b/a WACBD | Recruiting | Seattle | Washington | 98101 | United States |
| Arbesu Hematología | Recruiting | Mendoza | M5501 | Argentina |
| Royal Children's Hospital | Recruiting | Melbourne | Victoria | 3052 | Australia |
| HEMOES | Recruiting | Vitória | Espírito Santo | 29047-105 | Brazil |
| Stollery Children's Hospital | Recruiting | Edmonton | Alberta | T6G 2B7 | Canada |
| Hamilton Health Sciences - McMaster University Medical Centre | Recruiting | Hamilton | Ontario | L8N 3Z5 | Canada |
| Hamilton Health Sciences - McMaster University Medical Centre | Recruiting | Hamilton | Ontario | L8N3Z5 | Canada |
| Nanfang Hospital, Southern Medical University | Recruiting | Guangzhou | Guangdong | 510515 | China |
| The Affiliated Hospital of Guizhou Medical University | Recruiting | Guiyang | Guizhou | 550004 | China |
| Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology | Recruiting | Wuhan | Hubei | 430030 | China |
| Jiangxi Provincial People's Hospital | Recruiting | Nanchang | Jiangxi | 330006 | China |
| Jiangxi Provincial People's Hospital | Recruiting | Nanchang | Jiangxi | 330038 | China |
| Institute of hematology&blood disease hospital | Recruiting | Tianjin | Tianjin Municipality | China |
| Beijing Children's Hospital, Capital Medical University | Recruiting | Beijing | 100045 | China |
| Klinicki bolnicki centar Zagreb | Recruiting | Zagreb | 10000 | Croatia |
| Aarhus Universitetshospital, Skejby | Recruiting | Aarhus | Central Jutland | 8200 | Denmark |
| Hôpital Universitaire Necker Enfants Malades | Recruiting | Paris | 75015 | France |
| The University of Hong Kong (HKU)-Queen Mary Hospital (QMH) | Recruiting | Hong Kong | 999077 | Hong Kong |
| Prince of Wales Hospital | Recruiting | Hong Kong | Hong Kong |
| Queen Mary Hospital | Recruiting | Hong Kong | Hong Kong |
| The Chinese University of Hong Kong | Recruiting | Ma Liu Shui | Hong Kong |
| Nirmal Hospital Pvt Ltd. | Recruiting | Surat | Gjuarat | 395002 | India |
| K.J Somaiya Hospital & Research Centre, Somaiya Ayurvihar Complex | Recruiting | Mumbai | Maharashtra | 400022 | India |
| Sahyadri Super Speciality Hospital | Recruiting | Pune | Maharashtra | 411004 | India |
| Nil Ratan Sircar Medical College and Hospital | Recruiting | Kolkata | West Bengal | 700014 | India |
| Sheba Medical Center | Recruiting | Ramat Gan | Central District | 5262100 | Israel |
| IRCCS Istituto Giannina Gaslini | Recruiting | Genoa | Liguria | 16147 | Italy |
| Istituto Clinico Humanitas | Recruiting | Rozzano | Milano | 20089 | Italy |
| AOU Policlinico Umberto I | Recruiting | Roma | RM | 00161 | Italy |
| Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico | Recruiting | Milan | 20122 | Italy |
| Nagoya University Hospital - Transfusion Medicine | Recruiting | Nagoya | Aichi-ken | 466-8560 | Japan |
| Nagano Children's Hospital | Recruiting | Azumino | Nagano | 399-8288 | Japan |
| Nara Medical University Hospital | Recruiting | Kashihara | Nara | 634-0813 | Japan |
| Saitama Medical University Hospital | Recruiting | Lruma-gun | Saitama | 350-0495 | Japan |
| Saitama Children's Medical Center | Recruiting | Saitama-shi | Saitama | 330-8777 | Japan |
| Hiroshima University Hospital | Active, not recruiting | Hiroshima | 734-8551 | Japan |
| Saga University Hospital | Recruiting | Saga | 849-8501 | Japan |
| Centro Multidisciplinario para el Desarrollo Especializado de la Investigacion Clinica en Yucatán S. | Recruiting | Mérida | Yucatán | 97130 | Mexico |
| Sultan Qaboos University Hospital | Recruiting | Muscat | 123 | Oman |
| Institute for Mother and Child healthcare "Dr Vukan Cupic" | Recruiting | Belgrade | 11000 | Serbia |
| Clinical Center Nis | Recruiting | Niš | 18000 | Serbia |
| Clinical Center Nis | Active, not recruiting | Niš | 18000 | Serbia |
| Detska fakultna nemocnica Kosice | Recruiting | Košice | 040 11 | Slovakia |
| Univerzitna nemocnica Martin | Recruiting | Martin | 036 59 | Slovakia |
| Worthwhile Clinical Trials | Active, not recruiting | Benoni | Gauteng | 1500 | South Africa |
| Charlotte Maxeke Johannesburg Academic Hospital | Active, not recruiting | Johannesburg | Gauteng | 2193 | South Africa |
| WITS Health Consortium | Active, not recruiting | Johannesburg | Gauteng | 2193 | South Africa |
| Kyung Hee University Hospital at Gangdong | Recruiting | Seoul | Seoul-teukbyeolsi [seoul] | 05278 | South Korea |
| Severance Hospital, Yonsei University Health System | Recruiting | Seoul | Seoul-teukbyeolsi[seoul] | 03722 | South Korea |
| Kyungpook National University Hospital | Recruiting | Daegu | Taegu-kwangyǒkshi | 41944 | South Korea |
| Hospital Universitario A Coruna | Recruiting | A Coruña | 15006 | Spain |
| Hospital Universitario Vall d´Hebron | Recruiting | Barcelona | 08035 | Spain |
| Hospital Universitario La Paz | Recruiting | Madrid | 28046 | Spain |
| Hospital Universitario Miguel Servet | Recruiting | Zaragoza | 50009 | Spain |
| ChangHua Christian Hospital | Recruiting | Changhua | Changhua County | 500 | Taiwan |
| Taichung Veterans General Hospital | Recruiting | Taichung | 407219 | Taiwan |
| Acibadem Adana Hospital | Recruiting | Adana | 01130 | Turkey (Türkiye) |
| Hacettepe University Faculty of Medicine | Recruiting | Ankara | 06100 | Turkey (Türkiye) |
| Hacettepe University Medical Faculty Hospital | Recruiting | Ankara | 06230 | Turkey (Türkiye) |
| Gazi University Medical Faculty | Recruiting | Ankara | 06500 | Turkey (Türkiye) |
| Gazi University Health Research and Application Center Gazi Hospital | Recruiting | Ankara | 06560 | Turkey (Türkiye) |
| Gaziantep University Şahinbey Research and Practice Hospital | Recruiting | Gaziantep | 27310 | Turkey (Türkiye) |
| Istanbul University Oncology Institute | Recruiting | Istanbul | 34093 | Turkey (Türkiye) |
| Istanbul Universitesi Klinik Arastirmalar Mukemmeliyet Uygulama ve Arastirma Merkezi | Recruiting | Istanbul | 34452 | Turkey (Türkiye) |
| Ege University Faculty of Medicine | Recruiting | Izmir | 35040 | Turkey (Türkiye) |
| Ege University Faculty of Medicine | Recruiting | Izmir | 35100 | Turkey (Türkiye) |
| Erciyes University Faculty of Medicine | Recruiting | Kayseri | 38039 | Turkey (Türkiye) |
| Ondokuz Mayıs University Healthcare Practice and Research Center | Recruiting | Samsun | 55200 | Turkey (Türkiye) |
| Ondokuz Mayıs University Medical Faculty Local Laboratory | Recruiting | Samsun | 55280 | Turkey (Türkiye) |
| Royal Victoria Infirmary | Recruiting | Newcastle upon Tyne | England | NE1 4LP | United Kingdom |
| Guy's & St Thomas' NHS Foundation Trust | Recruiting | London | London, CITY of | SE1 9RT | United Kingdom |
| Guy's & St Thomas' NHS Foundation Trust, St Thomas' Hospital | Recruiting | London | SE1 7EH | United Kingdom |
| ID | Term |
|---|---|
| D006467 | Hemophilia A |
| D002836 | Hemophilia B |
| ID | Term |
|---|---|
| D025861 | Blood Coagulation Disorders, Inherited |
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D020147 | Coagulation Protein Disorders |
| D006474 | Hemorrhagic Disorders |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D040181 | Genetic Diseases, X-Linked |
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| ID | Term |
|---|---|
| C000656192 | marstacimab |
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