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A Study to Evaluate the Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of emicizumab in patients with mild or moderate hemophilia A without FVIII inhibitors
EU CTIS ID: 2023-506610-52-00
What this study is testing
Safety: 1. To evaluate safety profile of emicizumab in patients with non-severe hemophilia A without inhibitors Primary Efficacy: 2. To evaluate the efficacy of emicizumab on the basis of number of treated bleeds over time
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Diagnosis of mild (FVIII level between > 5% and < 40%) or moderate (FVIII level between >= 1% and <= 5%) congenital Hemophilia A without FVIII inhibitors
- Weight >= 3 kg
- Need for prophylaxis based on investigator assessment
- A negative test for inhibitor (i.e., < 0.6 BU/mL) within 8 weeks prior to enrollment
- No documented inhibitor (i.e., < 0.6 BU/mL), FVIII half-life < 6 hours, or FVIII recovery < 66% in the last 5 years
- Documentation of the details of prophylactic or episodic FVIII treatment and of number of bleeding episodes for at least the last 24 weeks prior to enrollment
You likely can't join if
- Inherited or acquired bleeding disorder other than mild (FVIII level between > 5% and < 40%) or moderate (FVIII level between >= 1% and <= 5%) congenital hemophilia A
- History of illicit drug or alcohol abuse within 48 weeks prior to screening, in the investigator’s judgment
- Previous (within the last 12 months) or current treatment for thromboembolic disease or signs of thromboembolic disease
- History of clinically significant hypersensitivity associated with monoclonal antibody therapies or components of the emicizumab injection
- Planned surgery during the emicizumab loading dose phase Surgeries in patients on emicizumab from Week 5 onwards are allowed
- Known HIV infection with CD4 counts < 200 cells/micro L
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.