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AN OPEN-LABEL STUDY IN PEDIATRIC (<18 YEARS OF AGE), SEVERE HEMOPHILIA A PARTICIPANTS (COAGULATION FACTOR ACTIVITY <1%) WITH OR WITHOUT INHIBITORS OR MODERATELY SEVERE TO SEVERE HEMOPHILIA B PARTICIPANTS (COAGULATION FACTOR ACTIVITY ≤2%) WITH OR WITHOUT INHIBITORS COMPARING 12 MONTHS OF HISTORICAL STANDARD TREATMENT TO MARSTACIMAB PROPHYLAXIS

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Trial Profile

AN OPEN-LABEL STUDY IN PEDIATRIC (<18 YEARS OF AGE), SEVERE HEMOPHILIA A PARTICIPANTS (COAGULATION FACTOR ACTIVITY <1%) WITH OR WITHOUT INHIBITORS OR MODERATELY SEVERE TO SEVERE HEMOPHILIA B PARTICIPANTS (COAGULATION FACTOR ACTIVITY ≤2%) WITH OR WITHOUT INHIBITORS COMPARING 12 MONTHS OF HISTORICAL STANDARD TREATMENT TO MARSTACIMAB PROPHYLAXIS

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 11 Jun 2026

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At a glance

  • Drugs Marstacimab (Primary)
  • Indications Haemophilia A; Haemophilia B
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms BASIS KIDS
  • Sponsors Pfizer

Most Recent Events

  • 08 Jun 2026 Interim results presented in the Pfizer media release.
  • 08 Jun 2026 According to a Pfizer media release, based on the results from BASIS and BASIS KIDS trial the U.S. FDA has approved an expanded indication for HYMPAVZI (marstacimab-hncq) to include the treatment of patients with hemophilia A or B 12 years and older with inhibitors and pediatric patients (ages 6 to 11 years) with or without inhibitors.
  • 14 Dec 2022 Status changed from not yet recruiting to recruiting.

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