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Monoclonal Antibodies
Marstacimab for Hemophilia (BASIS KIDS Trial)
Phase 3
Recruiting
Research Sponsored by Pfizer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to end of 12-month treatment period
Awards & highlights
No Placebo-Only Group
Pivotal Trial
Summary
This trial tests the safety & effectiveness of a new medicine to prevent bleeding episodes in pediatric hemophilia patients. Participants will get weekly subcutaneous shots & visit the study site 10 times over 14 months. Some visits may be done at home.
Who is the study for?
This trial is for boys with severe Hemophilia A or moderately to severe Hemophilia B, ages 1-17. They must have a history of consistent treatment and bleed documentation for at least a year, weigh enough (specifics vary by age), and not be on certain other treatments like gene therapy or non-factor replacement therapies.
What is being tested?
The study tests marstacimab's safety and effectiveness in preventing bleeding episodes in pediatric hemophilia patients. Participants will receive weekly subcutaneous shots of marstacimab over a 12-month period, with their experiences compared to historical data from when they weren't taking the medicine.
What are the potential side effects?
Potential side effects are not explicitly listed but may include reactions related to the injection site, allergic responses due to hamster protein content in the medication, or issues arising from underlying health conditions that could be exacerbated by treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to end of 12-month treatment period
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to end of 12-month treatment period
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Hemorrhage
Awards & Highlights
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.
Trial Design
1Treatment groups
Experimental Treatment
Group I: marstacimab (PF-06741086)Experimental Treatment1 Intervention
Weekly subcutaneous injections.
Find a Location
Who is running the clinical trial?
PfizerLead Sponsor
4,661 Previous Clinical Trials
17,844,825 Total Patients Enrolled
21 Trials studying Hemophilia B
4,988 Patients Enrolled for Hemophilia B
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,546 Previous Clinical Trials
14,885,981 Total Patients Enrolled
22 Trials studying Hemophilia B
2,014 Patients Enrolled for Hemophilia B
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with severe hemophilia A or moderate to severe hemophilia B.I have a surgery scheduled during the study period.I am using or plan to use clotting factor replacements or ITI therapy.I have previously taken marstacimab in a clinical study.I am a man of the right age and weight for the study.I am aged 6 to 11 and weigh at least 19 kg.I have a bleeding disorder that is not hemophilia A or B.My ECG shows unusual results that could impact my safety or study outcomes.I have documented my hemophilia treatment and bleeding episodes for the past year.I haven't taken any blood thinners or certain pain relievers in the last 5 days.I am currently on routine treatment for hemophilia that doesn't involve clotting factors.I regularly take medication that affects my immune system.I have not been in a drug or vaccine study within the last 30 days or 5 half-lives.I am between 12 and 17 years old and weigh at least 25 kg.I have a history of heart or blood clot issues.I haven't had inhibitors for 5 years, have used FVIII/FIX for 50 days, and followed my treatment plan for 12 months.I have hemophilia with inhibitors and have had bleeding episodes treated with bypassing agents.
Research Study Groups:
This trial has the following groups:- Group 1: marstacimab (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.
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