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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
All participants will have a minimum body weight of 35 kg
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to 7 year
Awards & highlights
Study Summary
This trial is an extension of a previous study to assess the long-term safety and efficacy of a prophylactic treatment for hemophilia A and B. Approximately 145 participants will receive injections of the marstacimab drug once weekly for the duration of the study.
Who is the study for?
This trial is for adolescents and adults aged 12 to <75 with severe hemophilia A or B, weighing at least 35 kg, who completed a prior study without early termination. It's not for those planning surgery, with unstable HIV or liver function, abnormal kidney function, using certain immune treatments, or having a history of significant heart or blood vessel problems.Check my eligibility
What is being tested?
The trial tests marstacimab (PF-06741086), given as a weekly subcutaneous injection to prevent bleeding in hemophilia patients. Participants from an earlier phase will continue treatment to assess long-term safety and effectiveness. An optional substudy uses a pre-filled pen for administration.See study design
What are the potential side effects?
While specific side effects are not listed here, common risks may include irritation at the injection site, potential allergic reactions to the drug components, and general discomfort associated with subcutaneous injections.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I weigh at least 35 kg.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline up to 7 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to 7 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Clinically significant changes in vital signs from baseline
Incidence and severity of injection site reaction
Incidence and severity of thrombotic events
+7 moreSecondary outcome measures
Annualized rate of bleeding episodes
Change in joints measured by the HJHS
Change in number of target joints per subject from baseline
+9 moreSide effects data
From 2020 Phase 2 trial • 20 Patients • NCT0336332125%
Haemarthrosis
25%
Haematoma
25%
Skin haemorrhage
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort 2: 300mg Loading + 150mg - 300mg Loading + 150mg Non-Inhibitor
Cohort 5: De Novo 300mg Loading + 150mg Inhibitors
Cohort 4: 300mg - 300mg Inhibitor
Cohort 3: 450mg - 300mg Loading + 150mg Non-Inhibitor
Cohort 1: 300mg - 300mg Non-Inhibitor
Trial Design
1Treatment groups
Experimental Treatment
Group I: PF-06741086Experimental Treatment1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PF-06741086
2021
Completed Phase 2
~100
Find a Location
Who is running the clinical trial?
PfizerLead Sponsor
4,570 Previous Clinical Trials
10,910,275 Total Patients Enrolled
43 Trials studying Hemophilia A
6,050 Patients Enrolled for Hemophilia A
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,475 Previous Clinical Trials
8,091,389 Total Patients Enrolled
42 Trials studying Hemophilia A
2,791 Patients Enrolled for Hemophilia A
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently using or plan to use immune tolerance therapy for my condition.You cannot participate in this study if you have recently participated in another research study involving experimental drugs or vaccines within the last 30 days or during this study. However, there is an exception if you participated in a study called B7841005.I am on regular treatment with drugs that affect my immune system.I have had serious heart or blood vessel problems.I weigh at least 35 kg.I have a surgery scheduled during the study period.My liver function is stable and suitable for the study.My kidney function is significantly reduced.
Research Study Groups:
This trial has the following groups:- Group 1: PF-06741086
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are the patients in this trial restricted to a certain age range?
"In order to meet the requirements for this clinical trial, potential participants must be aged 12 to 74. 41 studies have been conducted with patients younger than 18 and 64 with senior citizens."
Answered by AI
How many subjects are in this clinical trial?
"Yes, the trial is still recruiting patients, as of October 24th, 2022. According to the listing on clinicaltrials.gov, the trial was first posted on November 17th, 2021. They are currently looking for 145 participants at 1 location."
Answered by AI
Which patients would be a good match for this clinical trial?
"Patients with hemophilia A who are aged between 12 and 74 years old are eligible for this trial, of which around 145 patients will be enrolled."
Answered by AI
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