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NCT04307381 · ClinicalTrials.gov registry record · Phase 2
An Extension Study of Donidalorsen (IONIS-PKK-LRx) in Participants With Hereditary Angioedema
A Phase 2 study, sponsored by Ionis Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 20
- Enrollment target
NCT04307381: Completed Phase 2 study, sponsored by Ionis Pharmaceuticals.
NCT04307381 is a Phase 2 study that has completed, run by Ionis Pharmaceuticals. The registered enrollment target is 20 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04307381, a Phase 2 study, has completed, sponsored by Ionis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 20 participants
- Enrollment target
Study Summary
The purpose of this study was to evaluate the safety and efficacy of extended dosing of donidalorsen administered subcutaneously (SC), with alternative dosing and/or dose frequency with donidalorsen in participants with hereditary angioedema (HAE).
Primary Outcome
An adverse event (AE) was defined as any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not the AE is considered related to the medicinal (investigational) product. TEAEs were defined as those AEs that either started or worsened in severity on or after the date/time of first administration of study drug in this OLE Study. TEAEs included both seriou
Interventions
- DRUG Donidalorsen
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2020-03-31 |
| Est. Completion | 2025-01-24 |
| Phase | Phase 2 |
What the finished NCT04307381 record still lists
NCT04307381 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 1 intervention - of which Donidalorsen is the first listed.
NCT04307381 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04307381 about?
NCT04307381 is a clinical study titled "An Extension Study of Donidalorsen (IONIS-PKK-LRx) in Participants With Hereditary Angioedema". The purpose of this study was to evaluate the safety and efficacy of extended dosing of donidalorsen administered subcutaneously (SC), with alternative dosing and/or dose frequency with donidalorsen in participants with hereditary angioedema (HAE).
What is the current status of trial NCT04307381?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2020-03-31. Estimated completion is 2025-01-24.
What interventions are being tested in trial NCT04307381?
The interventions under investigation include: Donidalorsen (DRUG).
Who is sponsoring clinical trial NCT04307381?
This trial is sponsored by Ionis Pharmaceuticals, which has 76 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04307381's enrollment target sits among peer trials
20 1805th of 2000 higher than 107 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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