[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06703606":3,"trial-entities:NCT06703606":148,"trial-summary:NCT06703606":152},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":23,"primary_purpose":24,"phases":25,"enrollment_info":27,"interventions":30,"primary_outcomes":38,"secondary_outcomes":44,"sex":67,"minimum_age":68,"maximum_age":69,"healthy_volunteers":70,"eligibility_criteria":71,"std_ages":75,"locations":79,"central_contacts":134,"overall_officials":140,"references":143,"see_also_links":144},"NCT06703606","B7841014","A Study to Learn About How Changing Therapy From Emicizumab to Marstacimab Affects People With the Severe Hemophilia A.","A PHASE 1B OPEN-LABEL NON-RANDOMIZED STUDY TO ASSESS THE SAFETY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF MARSTACIMAB TREATMENT FOLLOWING THE DISCONTINUATION OF EMICIZUMAB THERAPY IN ADOLESCENT AND ADULT PARTICIPANTS WITH SEVERE HEMOPHILIA A WITHOUT INHIBITORS.","RECRUITING","2027-05-05","2026-06","2026-06-03","2025-05-13","Pfizer","INDUSTRY",true,"The purpose of the study is to learn about safety, how the body processes marstacimab and how it works in patients with severe hemophilia A without inhibitors. Hemophilia A is rare bleeding disorder where the blood doesn't clot normally. This causes a person to bleed a lot, even from a small cut.\n\nThese patients who are on emicizumab medicine for routine prophylaxis for at least 6 months, and desire to switch to marstacimab medicine. Inhibitors are antibodies that the immune system develops because it sees the infused clotting factor as a foreign substance that needs to be destroyed. Antibodies are proteins that eat up the activated factor before it has time to stop the bleeding. Prophylaxis are preventive medicines.\n\nThis study is seeking for participants:\n\n* with severe Hemophilia A withouth inhibitors who are on emicizumab treatment for at least 6 months.\n* must be 12 to less than 75 years old\n* must have a body weight of at least 35 kilograms. The results from this study will serve as a guide to doctors and their hemophilia A patients who will change their medicines in the real-world clinical setting. Patients who can take part in the study will receive marstacimab medicine as weekly injections under the skin of 150 milligrams for 4 months. Study treatment with marstacimab will be initiated no earlier than 14 days after last dose of emicizumab. The study can last up to 6 months. The sponsor will provide marstacimab. Patients will continue their usual treatment with the infused clotting factor for their bleeds when taking part in the study. Roll-over into an optional study treatment extension period will be available to participants who wish to continue prophylaxis with marstacimab in countries where it is not commercially available.","This is a non-randomized open-label study in approximately 10-15 adolescent and adult participants between ages 12 to \\\u003C75 years with severe hemophilia A (defined as FVIII activity \\\u003C1%) without inhibitors who are currently on treatment with emicizumab for ≥6 months. The study is designed to assess the safety and PK\u002FPD during a 4-month treatment period with marstacimab 150 mg SC QW after a minimum 14-day wash-out period following discontinuation of emicizumab. Assessment of safety will be conducted by summarizing AEs and SAEs reported during the study, from the time each participant provides informed consent through and including a minimum of 28 calendar days after last dose of study intervention. Participants will continue to use their standard of care factor replacement for breakthrough bleeds during the course of the study. PK, PD, and ADA measurements will support the clinical safety data. The anticipated study duration for an individual participant is approximately 6 months. After completion of marstacimab treatment period participants will resume their standard of care prophylactic treatment after a 14-day wash-out period following the last dose of marstacimab. Roll-over into an optional study treatment extension period will be available to participants who wish to continue prophylaxis with marstacimab in countries where it is not commercially available.",[19],"Severe Hemophilia A",[21,19,22],"Hemophilia A","Severe Hemophilia A Without Inhibitors","INTERVENTIONAL","TREATMENT",[26],"PHASE1",{"count":28,"type":29},15,"ESTIMATED",[31],{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":36},"DRUG","MARSTACIMAB","Marstacimab 150 mg administered subcutaneous (SC) once weekly (QW)",[33],[37],"PF-06741086",[39,42],{"measure":40,"timeFrame":41},"Incidence of marstacimab-related adverse events (AEs)","Approximately 178 days: from the time the participant provides informed consent, through and including a minimum of 28 calendar days after last dose of study treatment",{"measure":43,"timeFrame":41},"Incidence of marstacimab-related serious AEs (SAEs)",[45,48,50,52,54,57,59,61,63,65],{"measure":46,"timeFrame":47},"Plasma Concentration Versus Time of Marstacimab (Listings)","Day 1 up to day 135",{"measure":49,"timeFrame":47},"Maximum Observed Plasma Concentration (Cmax) of Marstacimab",{"measure":51,"timeFrame":47},"Average Plasma Concentration (Cavg) of Marstacimab",{"measure":53,"timeFrame":47},"Minimum Observed Plasma Concentration (Cmin)",{"measure":55,"timeFrame":56},"Change from baseline in tissue factor pathway inhibitor (TFPI).","Baseline, Day 1 up to day 135",{"measure":58,"timeFrame":56},"Change from baseline in prothrombin fragment 1+2 (PF 1+2)",{"measure":60,"timeFrame":56},"Change from baseline in D-dimer",{"measure":62,"timeFrame":56},"Change from baseline in TGA (thrombin generation assay).",{"measure":64,"timeFrame":47},"Incidence of Anti-Drug Antibody (ADA)",{"measure":66,"timeFrame":47},"Incidence of clinically significant persistent neutralizing antibodies (NAb)","MALE","12 Years","74 Years",false,{"inclusion":72,"exclusion":73,"raw_text":74},[],[],"Inclusion Criteria:\n\n1. Male and 12 to \\\u003C75 years of age with a minimum body weight of 35 kg at the time of signing the informed consent.\n2. Diagnosis of severe hemophilia A (FVIII activity \\\u003C1%) without inhibitors.\n3. On emicizumab therapy at a standard clinical dose for ≥6 months.\n\nExclusion Criteria:\n\n1. Previous or current treatment for or history of coronary artery diseases, venous or arterial thrombosis, or ischemic disease.\n2. Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation\u002Fbehavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.\n3. Known hemostatic defect other than hemophilia A.\n4. Current use of any prohibited concomitant medication(s) or unwillingness or inability to use a required concomitant medication(s).\n5. Previous administration of an investigational product (drug or vaccine) within 30 days or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer). Participation in studies of other investigational products (drug or vaccine) at any time during participation in this study.\n6. Platelet count \\\u003C100,000\u002Fμl or hemoglobin \\\u003C10 g\u002FdL.\n7. Clinically significant renal or hepatic function abnormality based on laboratory results at screening, or known kidney or liver disease.\n8. CD4 cell count ≤200\u002Fμl if HIV positive.\n9. Screening 12-lead ECG that demonstrates clinically significant abnormalities that, in the opinion of the investigator, may affect participant safety or interpretation of study results.\n10. Known planned surgical procedure.\n11. Hypersensitivity or allergic reaction to hamster protein or other components of the study intervention.\n12. Investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and sponsor and sponsor-delegate employees directly involved in the conduct of the study and their family members.",[76,77,78],"CHILD","ADULT","OLDER_ADULT",[80,89,97,100,109,117,126],{"facility":81,"status":8,"city":82,"state":83,"zip":84,"country":85,"geoPoint":86},"Orthopaedic Institute for Children\u002FOrthopaedic Hemophilia Treatment Center","Los Angeles","California","90007","United States",{"lat":87,"lon":88},34.05223,-118.24368,{"facility":90,"status":8,"city":91,"state":92,"zip":93,"country":85,"geoPoint":94},"Brody School of Medicine at East Carolina University","Greenville","North Carolina","27834",{"lat":95,"lon":96},35.61266,-77.36635,{"facility":98,"status":8,"city":91,"state":92,"zip":93,"country":85,"geoPoint":99},"ECU Health Medical Center",{"lat":95,"lon":96},{"facility":101,"status":8,"city":102,"state":103,"zip":104,"country":105,"geoPoint":106},"Nirmal Hospital Pvt Ltd.","Surat","Gujarat","395002","India",{"lat":107,"lon":108},21.19594,72.83023,{"facility":110,"status":8,"city":111,"state":112,"zip":113,"country":105,"geoPoint":114},"K J Somaiya Hospital & Research Centre","Mumbai","Maharashtra","400022",{"lat":115,"lon":116},19.07283,72.88261,{"facility":118,"status":8,"city":119,"state":120,"zip":121,"country":122,"geoPoint":123},"Ege University Faculty of Medicine Dean's Office","Bornova","İzmir","35100","Turkey (Türkiye)",{"lat":124,"lon":125},38.47921,27.2399,{"facility":127,"status":8,"city":128,"state":129,"zip":130,"country":122,"geoPoint":131},"Istanbul Universitesi Tıp Fakultesi Onkoloji Enstitusu","Fatih","İ̇stanbul","34093",{"lat":132,"lon":133},41.0225,28.94083,[135],{"name":136,"role":137,"phone":138,"email":139},"Pfizer CT.gov Call Center","CONTACT","1-800-718-1021","ClinicalTrials.gov_Inquiries@pfizer.com",[141],{"name":136,"affiliation":13,"role":142},"STUDY_DIRECTOR",[],[145],{"label":146,"url":147},"To obtain contact information for a study center near you, click here.","https:\u002F\u002Fpmiform.com\u002Fclinical-trial-info-request?StudyID=B7841014",{"nct_id":4,"conditions":149,"biomarkers":150},[21],[151],"F8 wt Allele",{"nct_id":4,"found":15,"summary":153,"prompt_version":163},{"design":154,"status":155,"heading":156,"summary":157,"follow_up":158,"word_count":159,"commitments":160,"compensation":161,"drugs_mentioned":162},"This is an open-label study, meaning you and your doctors will know which treatment you are receiving. It is not randomized, and about 10-15 participants will be included.","completed","A Study of Marstacimab for Severe Hemophilia A","This study is for men aged 12 to 74 with severe hemophilia A (a rare bleeding disorder where blood doesn't clot normally) who are currently taking emicizumab. The purpose is to understand the safety of switching from emicizumab to a new medicine called marstacimab. Researchers will look for any side effects (adverse events) that happen while taking marstacimab. You would be eligible if you have severe hemophilia A (FVIII activity \u003C1%) without inhibitors (antibodies that can make treatments less effective) and have been on emicizumab for at least 6 months. The study is currently unclear about its recruitment status and plans to enroll about 15 participants.","Your safety will be monitored for at least 28 days after your last dose of marstacimab.",106,"You would take marstacimab once weekly by injection under the skin for about 4 months, after a 14-day break from emicizumab. The total study duration for each participant is about 6 months.","Not stated in the trial record.",[33],"v2"]