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NCT05139810 · ClinicalTrials.gov registry record · Phase 3
OASIS-HAE: A Study to Evaluate the Safety and Efficacy of Donidalorsen (ISIS 721744 or IONIS-PKK-LRx) in Participants With Hereditary Angioedema (HAE)
A Phase 3 study of Hereditary Angioedema, sponsored by Ionis Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 91
- Enrollment target
- 20
- Study locations
NCT05139810 is a Phase 3 study of Hereditary Angioedema that has completed, run by Ionis Pharmaceuticals. The registered enrollment target is 91 participants, above the 69-participant average among 14 other Hereditary Angioedema trials with a reported enrollment target (32% higher). The trial reports 20 study locations across 13 states.
The verdict
NCT05139810, a Phase 3 study of Hereditary Angioedema, has completed, sponsored by Ionis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 91 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study was to evaluate the safety and efficacy of donidalorsen in participants with HAE and effect of donidalorsen on the quality and pattern of HAE attacks and their impact on quality of life (QoL).
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Donidalorsen
Study Locations (20)
Other
- Ionis Investigative Site - Brussels
- Ionis Investigative Site - Brussels
- Ionis Investigative Site - Edegem
- Ionis Investigative Site - Sofia
- Ionis Investigative Site - Sofia
California
- Ionis Investigative Site - San Diego
- Ionis Investigative Site - Santa Monica
- Ionis Investigative Site - Walnut Creek
Ohio
- Ionis Investigative Site - Columbus
- Ionis Investigative Site - Toledo
Arizona
- Ionis Investigative Site - Scottsdale
Colorado
- Ionis Investigative Site - Colorado Springs
Florida
- Ionis Investigative Site - Tampa
Kansas
- Ionis Investigative Site - Kansas City
Massachusetts
- Ionis Investigative Site - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 91 participants |
| Start Date | 2021-12-03 |
| Est. Completion | 2023-11-09 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05139810
The ClinicalTrials.gov registry entry for NCT05139810 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 91 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 69-participant average among 14 other Hereditary Angioedema trials with a reported enrollment target (32% higher). The listed sponsor is Ionis Pharmaceuticals, which has 76 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Hereditary Angioedema appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05139810 reports 20 study locations spanning 13 distinct geographic areas - top geographies include Other, California, Ohio.
Frequently Asked Questions
What is clinical trial NCT05139810 about?
NCT05139810 is a clinical study titled "OASIS-HAE: A Study to Evaluate the Safety and Efficacy of Donidalorsen (ISIS 721744 or IONIS-PKK-LRx) in Participants With Hereditary Angioedema (HAE)". The purpose of this study was to evaluate the safety and efficacy of donidalorsen in participants with HAE and effect of donidalorsen on the quality and pattern of HAE attacks and their impact on quality of life (QoL).
What is the current status of trial NCT05139810?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 91 participants. The study started on 2021-12-03. Estimated completion is 2023-11-09.
What conditions does trial NCT05139810 study?
This clinical trial studies the following conditions: Hereditary Angioedema.
What interventions are being tested in trial NCT05139810?
The interventions under investigation include: Placebo (DRUG), Donidalorsen (DRUG).
Who is sponsoring clinical trial NCT05139810?
This trial is sponsored by Ionis Pharmaceuticals, which has 76 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05139810 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Florida, Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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