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A Global, Open-label, Adaptive Design Study to Investigate the Efficacy and Safety of SerpinPC in Subjects With Severe Hemophilia A or Moderately Severe to Severe Hemophilia B (PRESent-2)
EU CTIS ID: 2022-502880-39-00
What this study is testing
To evaluate the efficacy and safety of prophylactic SerpinPC administered subcutaneously (SC) in subjects with moderately severe to severe hemophilia B (HemB)
- Therapeutic exploratory (Phase II)
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
- Male subjects ≥12 and ≤65 years of age with severe HemA, with or without inhibitors, or moderately severe to severe HemB, without high titer inhibitor (high titer inhibitor defined as ≥5 Bethesda Units [BU]/mL) and not requiring current treatment with bypass agents.
- Subject is currently included in a prophylaxis program OR subject is undergoing an on-demand treatment regimen; if the latter, must have had ≥6 documented acute bleeding episodes that required treatment during the 6 months before Screening
- At least 12 (Part 1) or 24 (Part 2) weeks of prospective documentation of bleeding episodes in the AP-0105 noninterventional study before dosing, or willing to complete the observation period in AP-0102
- No bleeding in the 7 days before Baseline (observation period can be extended if actively bleeding)
- Adequate hematologic, hepatic, and renal function, and D-dimer of ≤750 μg/L
You likely can't join if
- Known severe thrombophilia, previous deep vein thrombosis (excluding line-associated thrombosis), pulmonary embolism, myocardial infarction, stroke, uncontrolled hypertension (>160/100 mmHg) or has active cancer and/or requires therapy for cancer, except for basal cell carcinoma
- Subject with previous factor VIII or factor IX inhibitor who responded to immune tolerance induction and remains on prophylactic factor concentrate
- Body weight < 30 kg OR >150 kg OR body mass index >40 kg/m2
- Use of emicizumab in the 24 weeks before Baseline (Day 0) / Ongoing, or planned treatment with gene therapy for hemophilia / Current or planned treatment with anticoagulant or antiplatelet drugs
The study team makes the final eligibility decision.
Where it's taking place
- United States
- United Kingdom
- Turkey
- Canada
- Japan
- South Africa
- Brazil
- Egypt
- India
- Armenia
- Taiwan
- Australia
- Barbados
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 male, 0-17 years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States; United Kingdom; Turkey; Canada; Japan; South Africa and 7 more location(s). Enter your location above to see the nearest site and check your eligibility.
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.