A Study to Assess the Safety of Marstacimab and How Well it Works in People With Mild to Moderate Hemophilia A or B Without Inhibitors
NCT07923981, Phase 3, Recruiting, Pfizer
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | A Study to Assess the Safety of Marstacimab and How Well it Works in People With Mild to Moderate Hemophilia A or B Without Inhibitors | ClinicalTrials.gov |
| NCT number | NCT07923981 | ClinicalTrials.gov |
| Status | Recruiting | ClinicalTrials.gov |
| Phases | Phase 3 | ClinicalTrials.gov |
| Enrollment | 95 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Pfizer | ClinicalTrials.gov |
| Conditions | Hemophilia A or B | ClinicalTrials.gov |
| Interventions | marstacimab | ClinicalTrials.gov |
| First posted | 2026-11-09 | ClinicalTrials.gov |
| Last updated | 2026-11-09 | ClinicalTrials.gov |
Registered outcomes 48
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Annualized Bleeding Rate (ABR) of Treated Bleeding Events | Baseline (up to 12 months prior to informed consent) up to end of 12-month treatment phase | Derived for each subject for each period (historical and study treatment) by using the following formula: ABR = number of bleeds requiring treatment / (days on treatment period / 365.25) | ClinicalTrials.gov |
| Secondary | Incidence and Severity of Adverse Events and Serious Adverse Events | Screening to up to end of 12-month treatment phase including 30-day follow up (up to 15 months) | ClinicalTrials.gov | |
| Secondary | Incidence and Severity of Thrombotic Events | Baseline up to end of 12-month treatment phase including 30-day follow up (up to 13 months) | ClinicalTrials.gov | |
| Secondary | Incidence and Severity of Thrombotic Microangiopathy | Baseline up to end of 12-month treatment phase including 30-day follow up (up to 13 months) | ClinicalTrials.gov | |
| Secondary | Incidence and Severity of Disseminated Intravascular Coagulation/Consumption Coagulopathy | Baseline to end of 12-month treatment phase including 30-day follow up (up to 13 months) | ClinicalTrials.gov | |
| Secondary | Incidence and Severity of Injection Site Reactions | Baseline up to end of 12-month treatment phase including 30-day follow-up (up to 13 months) | ClinicalTrials.gov | |
| Secondary | Incidence of Severe Hypersensitivity Reactions, including Anaphylaxis | Baseline up to end of 12-month treatment phase including 30-day follow-up (up to 13 months) | ClinicalTrials.gov | |
| Secondary | Immunogenicity: Incidence of ADA and Clinically Significant Persistent NAb to Marstacimab | Baseline up to end of 12-month treatment phase including 30-day follow-up (up to 13 months) | ClinicalTrials.gov | |
| Secondary | ABR of Treated Joint Bleeds | Baseline (up to 12 months prior to informed consent) through the end of the 12-month treatment phase | ClinicalTrials.gov | |
| Secondary | ABR of Treated Spontaneous Bleeds | Baseline (up to 12 months prior to informed consent) through the end of the 12-month treatment phase | ClinicalTrials.gov | |
| Secondary | ABR of Treated Traumatic Bleeds | Baseline (up to 12 months prior to informed consent) through the end of the 12-month treatment phase | ClinicalTrials.gov | |
| Secondary | ABR of Total Bleeds (Treated and Untreated) | Baseline (up to 12 months prior to informed consent) through the end of the 12-month treatment phase | ClinicalTrials.gov | |
| Secondary | Number of Target Joints | Baseline up to end of 12-month treatment phase | ClinicalTrials.gov | |
| Secondary | ABR of Target Joint Bleeds | 12-month treatment phase (up to 12 months) | ClinicalTrials.gov | |
| Secondary | ABR of Treated Target Joint Bleeds | 12-month treatment phase (up to 12 months) | ClinicalTrials.gov | |
| Secondary | Change from Baseline in joint Health as Measured by the Hemophilia Joint Health Score (HJHS) | Baseline up to end of 12-month treatment phase | ClinicalTrials.gov | |
| Secondary | Change From Baseline in Hemophilia Early Arthropathy Detection With Ultrasound (HEAD-US) Score | Baseline up to end of 12-month treatment phase (up to 12 months) | ClinicalTrials.gov | |
| Secondary | Change from Baseline in the Hemophilia Activities List (HAL) | Baseline up to end of 12-month treatment phase | ClinicalTrials.gov | |
| Secondary | Change from Baseline in the Pediatric Hemophilia Activities List (pedHAL) | Baseline up to end of 12-month treatment phase | ClinicalTrials.gov | |
| Secondary | Patient Global Impression of Change-Hemophilia (PGIC-H) | Baseline up to end of 12-month treatment phase | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)