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A Phase I/IIb extension study assessing the long-term safety and efficacy of a gene therapy (AAV5-hFIX) previously administered to adult patients with severe or moderately severe haemophilia B during the CT-AMT-060-01 Phase I/II study.
EU CTIS ID: 2024-512603-39-00
What this study is testing
To assess the long-term safety (6-10 years after dosing, inclusive) of a systemic administration of CSL220, an AAV vector containing a codon-optimized human coagulation hFIX gene, to adult subjects with severe or moderately severe haemophilia B.
- Phase I and Phase II (Integrated)- First administration to humans
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
- Subjects with congenital haemophilia B who completed Study CSL220_1001
- Able to provide informed consent following receipt of verbal and written information about the trial
You likely can't join if
- Enrolled subjects will have already been assessed based on the exclusion criteria for Study CSL220_1001
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 male, 65+ years, 18-64 years. The study team makes the final eligibility decision.
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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.