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NCT04070326 · ClinicalTrials.gov registry record · Phase 3
A Study of Lanadelumab to Prevent Hereditary Angioedema (HAE) Attacks in Children
A Phase 3 study, sponsored by Shire.
- Completed
- Registry status
- Phase 3
- Development phase
- 21
- Enrollment target
NCT04070326: Completed Phase 3 study, sponsored by Shire.
NCT04070326 is a Phase 3 study that has completed, run by Shire. The registered enrollment target is 21 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04070326, a Phase 3 study, has completed, sponsored by Shire.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 21 participants
- Enrollment target
Study Summary
The main aims of this study are to learn how lanadelumab moves through a child's body and if the children have any medical problems from lanadelumab. Other aims are to learn if prophylactic treatment with lanadelumab reduces the number and severity of HAE attacks in children, how lanadelumab affects the child's body, and if the children develop antibodies to lanadelumab. The study doctors will treat acute HAE attacks according to their standard practice. Participants will receive lanadelumab for up to 52 weeks. When they start treatment, participants will visit their clinic every week for the first 4 weeks. Then, they will visit their clinic every 4 weeks during treatment.
Primary Outcome
An adverse event (AE) is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this investigational product or medicinal product. A SAE is any untoward clinical manifestation of signs, symptoms or outcomes (whether considered related to investigational product or not and at any dose which results in death, is life-threatening, requires inpatient hospitalization or prolongation of
Interventions
- DRUG Lanadelumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2019-08-19 |
| Est. Completion | 2021-10-30 |
| Phase | Phase 3 |
What the finished NCT04070326 record still lists
NCT04070326 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 1 intervention - of which Lanadelumab is the first listed.
NCT04070326 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04070326 about?
NCT04070326 is a clinical study titled "A Study of Lanadelumab to Prevent Hereditary Angioedema (HAE) Attacks in Children". The main aims of this study are to learn how lanadelumab moves through a child's body and if the children have any medical problems from lanadelumab. Other aims are to learn if prophylactic treatment with lanadelumab reduces the number and severity of HAE attacks in children, how lanadelumab affects...
What is the current status of trial NCT04070326?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 21 participants. The study started on 2019-08-19. Estimated completion is 2021-10-30.
What interventions are being tested in trial NCT04070326?
The interventions under investigation include: Lanadelumab (DRUG).
Who is sponsoring clinical trial NCT04070326?
This trial is sponsored by Shire, which has 245 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04070326's enrollment target sits among peer trials
21 1953rd of 2000 higher than 45 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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