ClinicalTrials.gg
RecruitingNCT05145127Updated Oct 26, 2026

Open-Label Extension Study of Marstacimab in Hemophilia Participants With or Without Inhibitors

A Phase 3 interventional study of PF-06741086 in Hemophilia A and Hemophilia B, sponsored by Pfizer. Recruiting at 78 sites in 24 countries. Open to male participants aged 1 Year to 74 Years. Per ClinicalTrials.gov, last updated 2026-10-26.

Sponsored by Pfizer · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Started Nov 2021; still recruiting 4 years 11 months later.
Updated Oct 26, 2026Site recruiting status changed3 sites addedGo to Updates ↓
Phase
Phase 3
Study type
Interventional
Enrollment
245
Allocation
Not applicable
Ages
1 Year to 74 Years
Sex
Male
01

Study summary

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 participants aged ≥6 to \<12 years. Based on the positive benefit/risk assessment conducted by both internal Pfizer review and eDMC review, dosing of the ≥6 to \<12 years age group was initiated in June 2023 in B7841008 Study. Data from participants ≥6 years from B7841008 Study and Study B7841005 will support the dosing of participants aged ≥1 to \<6 years.

All participants will be provided the prefilled pen (PFP) for administration of marstacimab in the study. Use of the prefilled syringe (PFS) will be permitted at the investigator's discretion for those participants who have difficulty with administration of the PFP. Additionally, participants will be provided the PFS for use in this study in countries where the PFS is anticipated to be the only presentation available commercially. An optional, open-label, single arm, substudy using the PFP was completed in the first 23 participants rolled over from Study B7841005 who agreed to participate in the substudy.

02

Conditions studied

  • Hemophilia A
  • Hemophilia B

Keywords

  • Factor VIII Inhibitor
  • Factor IX Inhibitor
  • PF-06741086
  • Marstacimab
  • Anti-TFPI
03

In context

Hemophilia A

844 studies on the registry are indexed under Hemophilia A; 138 are open to participants now.

This study's planned enrollment of 245 is above the median of 30 across 499 interventional studies indexed under Hemophilia A.

Browse Hemophilia A studies →

Lead sponsor

Pfizer is the lead sponsor of 3,334 studies on the registry; 149 are open to participants now.

Of its 601 completed or terminated interventional studies of FDA-regulated products, 391 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Year to 74 Years
Sexes eligible
Male
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • All participants will have a minimum body weight as defined by parent studies
  • Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures.
  • Participants have successfully completed participation in parent studies, defined as did not require "Early Termination"

Exclusion criteria

Exclusion Criteria:

  • Previous or current treatment for or history of coronary artery disease, venous or arterial thrombosis ( Grade >3), or ischemic disease (except catheter-associated thrombosis)
  • Abnormal renal function as defined by \<30 mL.min/1.73 m(2)
  • Known planned surgical procedure during the planned study period
  • Unstable hepatic function as determined by the Investigator clinical assessment and review of the participant's most recent laboratory results, which would make the participant inappropriate for the study
  • For participants known to be +, worsening disease status as determined by the Investigator clinical assessment and review of participant's most recent laboratory results, to include recent locally available (if available), which would make the participant inappropriate for the study
  • Regular, concomitant therapy with immunomodulatory drugs (eg, IVIG, and routine systemic , rituximab)
  • Ongoing or planned use of immune tolerance induction or prophylaxis with FVIII or FIX replacement during the study
  • Participation in other study involving drug(s) or investigational vaccine(s) within 30 days or 5 half-lives prior to or during study participation, with the exception of participation in parent studies
  • Investigator site staff or Pfizer employees directly involved in the conduct of the study, site staff otherwise supervised by the Investigator, and their respective family members
Terms in these criteria, in plain language(6)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

CTCAE grade

The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.

1
Mild.
2
Moderate.
3
Severe.
4
Life-threatening.
5
Death due to the event.

“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

CD4 count

The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
245 participants (estimated)

Study arms

  • Experimental
    PF-06741086

    For participants aged ≥12 years 300 milligrams(mg) subcutaneous (sc) loading dose followed by 150 mg sq once weekly (qw). 300 mg sc qw is prescribed for participants who meet dose escalation criteria. For participants aged ≥6 to \<12 years is marstacimab 150 mg SC for initial loading dose followed by 75 mg SC QW. 150 mg sc qw is prescribed for participants who meet dose escalation criteria.

    Drug: PF-06741086

Interventions

  • For participants aged ≥12 years 300 milligrams(mg) subcutaneous (sc) loading dose followed by 150 mg sq once weekly (qw). 300 mg sc qw is prescribed for participants who meet dose escalation criteria. For participants aged ≥6 to \<12 years is marstacimab 150 mg SC for initial loading dose followed by 75 mg SC QW. 150 mg sc qw is prescribed for participants who meet dose escalation criteria.

    Also known as: marstacimab

06

What researchers measure

Primary outcomes

  1. Number of subject reporting Adverse Events

    Time frame: Baseline up to 7 years

  2. Number of subjects reporting Serious Adverse Events

    Time frame: Baseline up to 7 years

  3. Incidence and severity of thrombotic events

    Time frame: Baseline up to 7 years

  4. Incidence and severity of thrombotic microangiopathy

    Time frame: Baseline up to 7 years

  5. Number of subjects reporting Disseminated intravascular coagulalopathy/consumption coagulopathy

    Time frame: Baseline up to 7 years

  6. Incidence of clinically significant persistent NAb against marstacimab

    Time frame: Baseline up to 7 years

  7. Incidence and severity of injection site reaction

    Time frame: Baseline up to 7 years

  8. Clinically significant changes in vital signs from baseline

    Time frame: Baseline up to 7 years

  9. Incidence of clinically significant laboratory value abnormalities

    Time frame: Baseline up to 7 years

  10. Incidence of severe hypersensitivity and anaphylactic reactions

    Time frame: Baseline up to 7 years

Secondary outcomes

  1. Annualized rate of bleeding episodes

    Derived for each subject for each treatment period by using the following formula: ABR = number of bleeds requiring treatments/ (days on treatment period / 365.25)

    Time frame: Baseline up to 7 years

  2. Total coagulation factor product consumption

    Time frame: Baseline up to 7 years

  3. Incidence of joint bleeds

    Time frame: Baseline up to 7 years

  4. Incidence of spontaneous bleeds

    Time frame: Baseline up to 7 years

  5. Incidence of target joint bleeds

    Time frame: Baseline up to 7 years

  6. Incidence of total bleeds (treated and untreated)

    Time frame: Baseline up to 7 year

  7. Change in joints measured by the HJHS

    Change in joints as measured by the HJHS for participants ≥4 years of age

    Time frame: Baseline up to 7 years

  8. Change in number of target joints per subject from baseline

    Time frame: Baseline up to 7 years

  9. Changes in Health Utilities Measure questionnaire data

    Time frame: Baseline up to 7 years

  10. Changes in Haem-A-QoL questionnaire data for participants ≥17 years of age

    Time frame: Baseline up to 7 years

  11. Changes in Haemo-QoL questionnaire data

    Haemo-QoL CII (Ages 8 to \<12 years), Haemo-QoL (Ages 12 to \<17),

    Time frame: Baseline up to 7 years

  12. Total bypass product consumption

    Time frame: Baseline up to 7 years

  13. Changes in EQ-5D questionnaire data

    EQ-5D-Y Proxy (Ages ≥ 4 to ≤ 6 years), EQ-5D-Y Self (Ages ≥ 7 to ≤ 11 years), EQ-5D-5L (Ages ≥12)

    Time frame: Baseline up to 7 years

07

Study locations

68 of 78 sites recruiting
08

References and documents

Individual participant data

Plan to share: Yes — Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Data sharing details ↗ · www.pfizer.com

09

Updates

1 registry update since Sep 25, 2026
Sites
3 sites added. Nagoya University Hospital - Transfusion Medicine is now Active, not recruiting
Show 3 added (1 Serbia, 1 Taiwan, 1 United Kingdom)
  • Clinical Center of Serbia · Belgrade, Serbia
  • National Taiwan University Hospital · Taipei, Taiwan
  • Birmingham Children's Hospital · Birmingham, United Kingdom
Oct 26, 2026
Show all 1 update
  1. Oct 26, 2026
    3 sites added. 3 sites changed recruiting status (2 now active, not recruiting, 1 now recruiting)
    Show 3 sites
    • Nagoya University Hospital - Transfusion Medicine · Nagoya, JapanRecruiting→Active, not recruiting
    • Clinical Center Nis · Niš, SerbiaRecruiting→Active, not recruiting
    • Clinical Center Nis · Niš, SerbiaActive, not recruiting→Recruiting
    Show 3 added (1 Serbia, 1 Taiwan, 1 United Kingdom)
    • Clinical Center of Serbia · Belgrade, Serbia
    • National Taiwan University Hospital · Taipei, Taiwan
    • Birmingham Children's Hospital · Birmingham, United Kingdom
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT05145127
Lead sponsor
Pfizer
Responsible party
Sponsor
First posted
Dec 6, 2021
Start date
Nov 17, 2021
Primary completion
Jul 31, 2030 (estimated)
Completion
Jul 31, 2030 (estimated)
Last update
Oct 26, 2026

Study contacts

Pfizer CT.gov Call Center
Contact
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021
Pfizer CT.gov Call Center
study director · Pfizer

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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