Open-Label Extension Study of Marstacimab in Hemophilia Participants With or Without Inhibitors
NCT ID: NCT05145127
Last Updated: 2024-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
245 participants
INTERVENTIONAL
2021-11-17
2030-07-31
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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PF-06741086
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.
PF-06741086
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.
Interventions
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PF-06741086
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures.
* Participants have successfully completed participation in parent studies, defined as did not require "Early Termination"
Exclusion Criteria
* Abnormal renal function as defined by eGFR \<30 mL.min/1.73 m(2)
* Known planned surgical procedure during the planned study period
* 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
* 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
* Regular, concomitant therapy with immunomodulatory drugs (eg, IVIG, and routine systemic corticosteroids, rituximab)
* Ongoing or planned use of immune tolerance induction or prophylaxis with FVIII or FIX replacement during the study
* 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
* 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
1 Year
74 Years
MALE
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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University of Iowa
Iowa City, Iowa, United States
Northwell Health HTC
New Hyde Park, New York, United States
Washington Institute for Coagulation d/b/a WACBD
Seattle, Washington, United States
Royal Children's Hospital
Melbourne, Victoria, Australia
Stollery Children's Hospital
Edmonton, Alberta, Canada
Hamilton Health Sciences - McMaster University Medical Centre
Hamilton, Ontario, Canada
Hamilton Health Sciences - McMaster University Medical Centre
Hamilton, Ontario, Canada
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China
The Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou, China
The Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou, China
Tongji Hospital Tongji Medical,Science & Technology
Wuhan, Hubei, China
Jiangxi Provincial People's Hospital
Nanchang, Jiangxi, China
Institute of hematology&blood disease hospital
Tianjin, Tianjin Municipality, China
Institute of hematology&blood disease hospital
Tianjin, Tianjin Municipality, China
Beijing Children's Hospital, Capital Medical University
Beijing, , China
Klinicki bolnicki centar Zagreb
Zagreb, , Croatia
Hôpital Universitaire 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, Gjuarat, India
K.J. Somaiya Hospital
Mumbai, Maharashtra, India
Sahyadri Super Speciality Hospital
Pune, Maharashtra, India
Nil Ratan Sircar Medical College and Hospital
Kolkata, West Bengal, India
Sheba Medical Center
Ramat Gan, Central District, Israel
AOU Policlinico Umberto I
Roma, RM, Italy
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
Milan, , Italy
Nagoya University Hospital - Transfusion Medicine
Nagoya, Aichi-ken, Japan
Nagano Children's Hospital
Azumino, Nagano, Japan
Nara Medical University Hospital
Kashihara, Nara, Japan
Saitama Children's Medical Center
Saitama-shi, Saitama, Japan
Hiroshima University Hospital
Hiroshima, , Japan
Centro Multidisciplinario para el Desarrollo Especializado de la Investigacion Clinica en Yucatan
Mérida, Yucatán, Mexico
Centro Multidisciplinario para el Desarrollo Especializado de la Investigacion Clinica en Yucatán S.
Mérida, Yucatán, Mexico
Sultan Qaboos University Hospital
Muscat, , Oman
Institute for Mother and Child healthcare "Dr Vukan Cupic"
Belgrade, , Serbia
Clinical Center Nis
Niš, , Serbia
Worthwhile Clinical Trials
Benoni, Gauteng, South Africa
Charlotte Maxeke Johannesburg Academic Hospital
Johannesburg, Gauteng, South Africa
Worthwhile Clinical Trials
Benoni, , South Africa
Charlotte Maxeke Johannesburg Academic Hospital
Johannesburg, , South Africa
Severance Hospital, Yonsei University Health System
Seoul, Seoul-teukbyeolsi [seoul], South Korea
Kyung Hee University Hospital at Gangdong
Seoul, Seoul-teukbyeolsi [seoul], South Korea
Severance Hospital, Yonsei University Health System
Seoul, Seoul-teukbyeolsi[seoul], South Korea
Kyungpook National University Hospital
Daegu, Taegu-kwangyǒkshi, South Korea
Hospital Universitario A Coruna
A Coruña, , Spain
Hospital Universitario Vall d´Hebron
Barcelona, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Hospital Universitario La Paz
Madrid, , 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 Faculty of Medicine
Ankara, , Turkey (Türkiye)
Gazi University Health Research and Application Center Gazi Hospital
Ankara, , Turkey (Türkiye)
Gaziantep University Şahinbey Research and Practice Hospital
Gaziantep, , Turkey (Türkiye)
Istanbul University Oncology Institute
Istanbul, , Turkey (Türkiye)
Ege University Faculty of Medicine
Izmir, , Turkey (Türkiye)
Ege University Faculty of Medicine
Izmir, , Turkey (Türkiye)
Erciyes University Faculty of Medicine
Kayseri, , Turkey (Türkiye)
Ondokuz Mayıs University Healthcare Practice and Research Center
Samsun, , Turkey (Türkiye)
Countries
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Central Contacts
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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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PHASE 3 ANTI-TFPI OLE
Identifier Type: OTHER
Identifier Source: secondary_id
2022-500470-33-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
B7841007
Identifier Type: -
Identifier Source: org_study_id