Condition: Hemophilia A · Hemophilia B · Sponsor: Pfizer
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 participant…
This description comes directly from the study's public registry record.
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| University of Iowa | Iowa City, Iowa, United States | Active Not Recruiting |
| Northwell Health HTC | New Hyde Park, New York, United States | Recruiting |
| The Feinstein Institutes for Medical Research | Philadelphia, Pennsylvania, United States | Recruiting |
| Washington Institute for Coagulation d/b/a WACBD | Seattle, Washington, United States | Recruiting |
| Arbesu Hematología | Mendoza, Argentina | Recruiting |
| Royal Children's Hospital | Melbourne, Victoria, Australia | Recruiting |
| HEMOES | Vitória, Espírito Santo, Brazil | Recruiting |
| Stollery Children's Hospital | Edmonton, Alberta, Canada | Recruiting |
| Hamilton Health Sciences - McMaster University Medical Centre | Hamilton, Ontario, Canada | Recruiting |
| Hamilton Health Sciences - McMaster University Medical Centre | Hamilton, Ontario, Canada | Recruiting |
| Nanfang Hospital, Southern Medical University | Guangzhou, Guangdong, China | Recruiting |
| The Affiliated Hospital of Guizhou Medical University | Guiyang, Guizhou, China | Recruiting |
+ 63 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT05145127