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NCT04444895 · ClinicalTrials.gov registry record · Phase 3
A Study of Long-Term Safety and Efficacy of Lanadelumab for Prevention of Acute Attacks of Non-histaminergic Angioedema With Normal C1-Inhibitor
A Phase 3 study, sponsored by Shire.
- Completed
- Registry status
- Phase 3
- Development phase
- 73
- Enrollment target
NCT04444895: Completed Phase 3 study, sponsored by Shire.
NCT04444895 is a Phase 3 study that has completed, run by Shire. The registered enrollment target is 73 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04444895, a Phase 3 study, has completed, sponsored by Shire.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 73 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the long-term safety and efficacy of repeated subcutaneous (SC) administration of lanadelumab in adolescents and adults with non-histaminergic angioedema with normal C1-inhibitor who completed study SHP643-303 (NCT04206605).
Primary Outcome
TEAE: Any event emerging or manifesting at or after initiation of treatment with investigational product (IP) or medicinal product or any existing event that worsens in either intensity or frequency following exposure to IP or medicinal product including clinically meaningful findings in laboratory safety tests, vital signs, weight, and electrocardiogram (ECG) findings. SAE: Any untoward clinical manifestation of signs, symptoms or outcomes (whether considered related to IP or not and at any dos
Interventions
- DRUG Lanadelumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 73 participants |
| Start Date | 2021-02-05 |
| Est. Completion | 2023-05-05 |
| Phase | Phase 3 |
What the finished NCT04444895 record still lists
NCT04444895 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 73 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (91% lower).
The record links to 0 conditions, and to 1 intervention - of which Lanadelumab is the first listed.
NCT04444895 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04444895 about?
NCT04444895 is a clinical study titled "A Study of Long-Term Safety and Efficacy of Lanadelumab for Prevention of Acute Attacks of Non-histaminergic Angioedema With Normal C1-Inhibitor". The purpose of this study is to evaluate the long-term safety and efficacy of repeated subcutaneous (SC) administration of lanadelumab in adolescents and adults with non-histaminergic angioedema with normal C1-inhibitor who completed study SHP643-303 (NCT04206605).
What is the current status of trial NCT04444895?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 73 participants. The study started on 2021-02-05. Estimated completion is 2023-05-05.
What interventions are being tested in trial NCT04444895?
The interventions under investigation include: Lanadelumab (DRUG).
Who is sponsoring clinical trial NCT04444895?
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 NCT04444895's enrollment target sits among peer trials
73 1780th of 2000 higher than 221 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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