BridgeMD
Donidalorsen Treatment in Children with Hereditary Angioedema
EU CTIS ID: 2025-523499-22-00
What this study is testing
Evaluate the safety, tolerability and pharmacokinetics of donidalorsen in pediatric participants with HAE
- 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
- 3. Must be between the ages of 2 and less than 12 years, inclusive, at the time of informed consent and, as applicable, assent.
- 4. Must weigh at least 9 kg at the time of informed consent and, as applicable, assent.
- 6. Documented diagnosis of HAE-1/HAE-2 based upon both of the following: a. Documented clinical history consistent with HAE b. Diagnostic testing results that confirm HAE-1/HAE-2
You likely can't join if
- 2. Must not have any screening laboratory abnormalities or any other clinically significant abnormalities during screening that would render a participant unsuitable for inclusion
- 12. Concurrent diagnosis of any other type of recurrent angioedema, including idiopathic angioedema or HAE with normal C1-INH (HAE-nC1-INH or Type III).
- 8. Must not have been treated with another investigational drug, biological agent, or device within 1 month of Screening, or 5 half-lives of investigational agent, whichever is longer.
The study team makes the final eligibility decision.
Where it's taking place
- Canada
- United States
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. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Canada; United States. 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.