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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 screening through end of follow-up period (approximately 14 months)

Awards & highlights

BASIS KIDS 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.Check my eligibility

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.See study design

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.

BASIS KIDS Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ screening through end of follow-up period (approximately 14 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~screening through end of follow-up period (approximately 14 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and screening through end of follow-up period (approximately 14 months) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Hemorrhage

Immunogenicity (incidence of ADA and clinically significant persistent NAb against marstacimab)

Disseminated Intravascular Coagulation

+5 more

Secondary outcome measures

Change from baseline in joint health as measured by the HJHS for participants ≥4 years of age

Changes in quality of life measured by Haem-A-QoL/Haemo-QoL (using age-dependent versions for participants ≥8 years of age)

Changes in quality of life measured by Health Utilities Measure (EQ-5D-Y) for participants ≥4 years of age

+7 more

BASIS KIDS Trial Design

1Treatment groups

Experimental Treatment

Group I: marstacimab (PF-06741086)Experimental Treatment1 Intervention

Weekly subcutaneous injections.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

PfizerLead Sponsor

4,570 Previous Clinical Trials

10,915,903 Total Patients Enrolled

43 Trials studying Hemophilia A

6,115 Patients Enrolled for Hemophilia A

Pfizer CT.gov Call CenterStudy DirectorPfizer

3,476 Previous Clinical Trials

8,092,121 Total Patients Enrolled

42 Trials studying Hemophilia A

2,856 Patients Enrolled for Hemophilia A

Media Library

Marstacimab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05611801 — Phase 3

Hemophilia A Research Study Groups: marstacimab (PF-06741086)

Hemophilia A Clinical Trial 2023: Marstacimab Highlights & Side Effects. Trial Name: NCT05611801 — Phase 3

Marstacimab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05611801 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What type of individual would make an ideal participant in this experiment?

"For eligibility in this trial, potential candidates must have hemophilia a and should be between 1 year old to 17 years of age. Approximately 100 people are being enrolled into the study."

Answered by AI

How many sites are actively conducting this clinical trial?

"This clinical trial currently has 17 sites enrolling patients, including the Nagano Children's Hospital in Azumino, Saga University Hospital in Saga and Kyungpook National University Hospital in Daegu."

Answered by AI

Are individuals over 25 years old eligible to join this clinical experiment?

"According to the study requirements, individuals may be enrolled in this trial if they are between 1 and 17 years of age."

Answered by AI

Has marstacimab (PF-06741086) been granted regulatory approval by the FDA?

"Our team has assigned marstacimab (PF-06741086) a score of 3 due to the multiple rounds of data that have been collected in support of its efficacy and safety."

Answered by AI

What is the estimated enrollment capacity for this medical experiment?

"This clinical trial necessitates the involvement of 100 eligible individuals. The two main sites for participation are Nagano Children's Hospital in Azumino, and Saga University Hospital located within Taegu-kwangyǒkshi."

Answered by AI

Is recruitment still open for this trial?

"Affirmative, records on clinicaltrials.gov reveal that this trial is actively recruiting participants. Initially posted in December of 2022 and most recently updated April 25th 2023, the study seeks 100 individuals from 17 different locations."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Clinical Trial of Study Medicine (Marstacimab) in Pediatric Patients With Hemophilia A or Hemophilia B

2022. "A Clinical Trial of Study Medicine (Marstacimab) in Pediatric Patients With Hemophilia A or Hemophilia B". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05611801.

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