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

Who is this study for? Patients with severe hemophilia B
What treatments are being studied? PF-06741086
Status: Recruiting
Location: See all (58) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

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.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 1
Maximum Age: 74
Healthy Volunteers: f
View:

• All participants will have a minimum body weight as defined by parent studies

• 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

Locations
United States
Iowa
University of Iowa
RECRUITING
Iowa City
New York
Northwell Health HTC
RECRUITING
New Hyde Park
Washington
Washington Institute for Coagulation d/b/a WACBD
RECRUITING
Seattle
Other Locations
Australia
Royal Children's Hospital
RECRUITING
Melbourne
Canada
Stollery Children's Hospital
RECRUITING
Edmonton
Hamilton Health Sciences - McMaster University Medical Centre
RECRUITING
Hamilton
China
Beijing Children's Hospital, Capital Medical University
RECRUITING
Beijing
Nanfang Hospital, Southern Medical University
RECRUITING
Guangzhou
The Affiliated Hospital of Guizhou Medical University
NOT_YET_RECRUITING
Guiyang
The Affiliated Hospital of Guizhou Medical University
RECRUITING
Guiyang
Jiangxi Provincial People's Hospital
RECRUITING
Nanchang
Institute of hematology&blood disease hospital
RECRUITING
Tianjin
Institute of hematology&blood disease hospital
RECRUITING
Tianjin
Tongji Hospital Tongji Medical,Science & Technology
RECRUITING
Wuhan
Croatia
Klinicki bolnicki centar Zagreb
RECRUITING
Zagreb
France
Hôpital Universitaire Necker Enfants Malades
RECRUITING
Paris
Hong Kong Special Administrative Region
Prince of Wales Hospital
RECRUITING
Hong Kong
Queen Mary Hospital
RECRUITING
Hong Kong
India
Nil Ratan Sircar Medical College and Hospital
NOT_YET_RECRUITING
Kolkata
K.J. Somaiya Hospital
RECRUITING
Mumbai
Sahyadri Super Speciality Hospital
RECRUITING
Pune
Nirmal Hospital Pvt Ltd.
RECRUITING
Surat
Israel
Sheba Medical Center
RECRUITING
Ramat Gan
Italy
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
RECRUITING
Milan
AOU Policlinico Umberto I
RECRUITING
Roma
Japan
Nagano Children's Hospital
RECRUITING
Azumino
Hiroshima University Hospital
RECRUITING
Hiroshima
Nara Medical University Hospital
NOT_YET_RECRUITING
Kashihara
Nagoya University Hospital - Transfusion Medicine
RECRUITING
Nagoya
Saitama Children's Medical Center
RECRUITING
Saitama-shi
Mexico
Centro Multidisciplinario para el Desarrollo Especializado de la Investigacion Clinica en Yucatan
RECRUITING
Mérida
Centro Multidisciplinario para el Desarrollo Especializado de la Investigacion Clinica en Yucatán S.
RECRUITING
Mérida
Oman
Sultan Qaboos University Hospital
RECRUITING
Muscat
Republic of Korea
Kyungpook National University Hospital
RECRUITING
Daegu
Kyung Hee University Hospital at Gangdong
RECRUITING
Seoul
Severance Hospital, Yonsei University Health System
RECRUITING
Seoul
Serbia
Institute for Mother and Child healthcare Dr Vukan Cupic
RECRUITING
Belgrade
Clinical Center Nis
RECRUITING
Niš
South Africa
Worthwhile Clinical Trials
ACTIVE_NOT_RECRUITING
Benoni
Worthwhile Clinical Trials
NOT_YET_RECRUITING
Benoni
Charlotte Maxeke Johannesburg Academic Hospital
NOT_YET_RECRUITING
Johannesburg
Charlotte Maxeke Johannesburg Academic Hospital
RECRUITING
Johannesburg
Spain
Hospital Universitario A Coruna
RECRUITING
A Coruña
Hospital Universitario Vall d´Hebron
RECRUITING
Barcelona
Hospital Universitario La Paz
RECRUITING
Madrid
Hospital Universitario La Paz
RECRUITING
Madrid
Hospital Universitario Miguel Servet
RECRUITING
Zaragoza
Taiwan
ChangHua Christian Hospital
RECRUITING
Changhua
Taichung Veterans General Hospital
RECRUITING
Taichung
Turkey
Acibadem Adana Hospital
RECRUITING
Adana
Gazi University Health Research and Application Center Gazi Hospital
RECRUITING
Ankara
Hacettepe University Faculty of Medicine
RECRUITING
Ankara
Gaziantep University Şahinbey Research and Practice Hospital
RECRUITING
Gaziantep
Istanbul University Oncology Institute
RECRUITING
Istanbul
Ege University Faculty of Medicine
RECRUITING
Izmir
Ege University Faculty of Medicine
RECRUITING
Izmir
Erciyes University Faculty of Medicine
RECRUITING
Kayseri
Ondokuz Mayıs University Healthcare Practice and Research Center
RECRUITING
Samsun
Contact Information
Primary
Pfizer CT.gov Call Center
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021
Time Frame
Start Date: 2021-11-17
Estimated Completion Date: 2030-07-31
Participants
Target number of participants: 245
Treatments
Experimental: 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.
Related Therapeutic Areas
Sponsors
Leads: Pfizer

This content was sourced from clinicaltrials.gov

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