Comparison of Outcomes Between Low Dose Emicizumab and Extended Half-life Factor VIII With Pharmacokinetic-guided Prophylaxis in Clinically Severe Hemophilia A
"Emicizumab", "HEMLIBRA®"
Blood Coagulation Disorders+12
+ Hemarthrosis
+ Hematologic Diseases
Treatment Study
Summary
Study start date: June 22, 2023
Actual date on which the first participant was enrolled.This study is focused on comparing two treatments for individuals with severe Hemophilia A, a condition where blood does not clot properly, leading to excessive bleeding. The study looks at low-dose Emicizumab and low-dose extended half-life Factor VIII treatment. These treatments are being compared to see which one better reduces bleeding episodes and improves quality of life. This is important as it could lead to more effective and manageable treatment options for people with severe Hemophilia A. Participants in the study will receive either low-dose Emicizumab or low-dose Factor VIII. Emicizumab is administered as an injection, while Factor VIII is typically given intravenously. Researchers will measure outcomes such as the annual bleeding rate, joint health, and overall quality of life. The study will also explore how the body processes these treatments and note any side effects. This information will help determine the most effective and safe treatment for reducing bleeding in Hemophilia A patients.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.15 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Male
Biological sex of participants that are eligible to enroll.From 3 to 30 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
King Chulalongkorn Memorial hospital
Bangkok, ThailandOpen King Chulalongkorn Memorial hospital in Google Maps