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NCT05611801 (Marstacimab in Hemophilia A Hemophilia B): BVCT ex-ante prediction vs. reported outcome

On 15 Jan 2024, BioinvestGPT's BVCT predicted technical success and commercial success for this trial. The 26 Jun 2025 readout is classified on the dashboard as True Positive (TP), a correct prediction. Recorded clinical-benefit conclusion: statistically significant and commercially sufficient.

Clinical Trial

NCTID
NCT05611801
Acronym
BASIS KIDS
Drug Name
Marstacimab
Drug MoA
anti-TFPI mAb inhibitor
Drug Modality
monoclonal antibody
Drug Class
First-In-Class
Therapeutic Area
Hematologic Diseases
Indication
Hemophilia A Hemophilia B
Human Patients
100
Sponsor
Pfizer
Phase
Phase 3

Prediction of , index 1415

Prospective Prediction
Prediction Index
1415
Prediction Date
Commercial Prediction
SUCCESS (commercially sufficient clinical benefit more for patients with inhibitors)
Technical Prediction
SUCCESS (statistically significant clinical benefit)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
528 days in advance
Readout Data Interpretation
marstacimab achieved 93% reduction in ABR over 12 months superior to on-demand treatment (1.39 vs 19.78 p < 0.0001) and achieved superiority in all bleeding-related secondary endpoints
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant and commercially sufficient
Prediction Classification
True Positive (TP)

ClinicalTrials.gov record

ClinicalTrials.gov record, retrieved 2026-09-24. Third-party data.

Official title
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
Phase
Phase 3
Status
Recruiting
Enrollment
100
Lead sponsor
Pfizer
Conditions
Hemophilia A; Hemophilia B
Interventions
DRUG: marstacimab
Design
Single group · None
Primary purpose
Treatment
Start
2022-12-09
Primary completion
2028-09-10
Completion
2028-09-10
Primary outcomes
  • Annualized bleeding rate (ABR) of treated bleeding events (Baseline to end of 12-month treatment period)
  • Incidence of adverse events and serious adverse events (Screening through end of follow-up period (approximately 14 months))
  • Incidence and severity of thrombotic events (Baseline to end of 12-month treatment period)
  • Incidence and severity of thrombotic microangiopathy (Baseline to end of 12-month treatment period)
  • Incidence and severity of disseminated intravascular coagulation/consumption coagulopathy events (Baseline to end of 12-month treatment period)

NCT05611801 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

How to read these records: evidence · methodology · all trials