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Tailored Regimen for Hemophilia A (PMCH Trial)
N/A
Recruiting
Led By Alfonso Iorio, MD, PhD, FRCPC
Research Sponsored by McMaster University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measured at study enrollment and at 2 years at study completion.
Awards & highlights
PMCH Trial Summary
This trial will assess the impact of adopting population PK (popPK) based tailored prophylaxis in clinical practice, including proportion of patients eligible for tailoring, and encountered barriers.
Eligible Conditions
- Hemophilia A
- Hemophilia B
PMCH Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ measured at study enrollment and at 2 years at study completion.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measured at study enrollment and at 2 years at study completion.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Annualized Bleeding Rate (ABR) pre and post-tailoring implementation
Change in patient quality of life
Secondary outcome measures
Adherence to prescribed regimen
Assessment of the predictive performance of the WAPPS-Hemo clinical calculator
Change in joint function
+4 morePMCH Trial Design
1Treatment groups
Experimental Treatment
Group I: Tailored RegimenExperimental Treatment1 Intervention
Implementation of WAPPS-Hemo personalized dosing regimen.
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Who is running the clinical trial?
McMaster UniversityLead Sponsor
891 Previous Clinical Trials
2,604,866 Total Patients Enrolled
2 Trials studying Hemophilia A
1,400 Patients Enrolled for Hemophilia A
Alfonso Iorio, MD, PhD, FRCPCPrincipal InvestigatorMcMaster University
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You are taking a medication to prevent bleeding episodes.You have a bleeding disorder that is not Hemophilia A or B.
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.
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Tailored Regimen
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