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NCT02316353 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate the Long-term Clinical Safety and Efficacy of Subcutaneously Administered C1-esterase Inhibitor in the Prevention of Hereditary Angioedema
A Phase 3 study of Hereditary Angioedema Types I and II, sponsored by CSL Behring.
- Completed
- Registry status
- Phase 3
- Development phase
- 126
- Enrollment target
- 20
- Study locations
NCT02316353: Completed Phase 3 study of Hereditary Angioedema Types I and II, sponsored by CSL Behring.
NCT02316353 is a Phase 3 study of Hereditary Angioedema Types I and II that has completed, run by CSL Behring. The registered enrollment target is 126 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (84% lower). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02316353, a Phase 3 study of Hereditary Angioedema Types I and II, has completed, sponsored by CSL Behring.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 126 participants
- Enrollment target
- 20
- Study locations
Study Summary
The aim of this study is to assess the long-term safety of C1-esterase inhibitor (C1-INH) in preventing hereditary angioedema (HAE) attacks when it is administered under the skin of subjects with HAE. The safety of participating subjects will be assessed for up to 54 weeks. The long-term efficacy of C1-INH will also be assessed. Each eligible subject will enter the treatment phase, wherein subjects will be randomized to treatment with either low- or medium-volume C1-INH. Subjects who have an insufficient treatment response during the study will be given an opportunity to undergo a dose increase. The study aims to enroll eligible subjects who completed study CSL830\_3001 (NCT01912456). Subjects who did not participate in study CSL830\_3001 may also participate, if eligible and if space permits. Subjects from the United States (US) who complete Treatment Period 2 will be allowed to participate in an Extension Period. During the Extension Period participating US subjects will continue to receive treatment with open-label CSL830 for up to an additional 88 weeks.
Primary Outcome
Subject-based Analysis for Person-Time Incidence Rate = (the total number of subjects who experienced the event during the respective treatment) / (the sum of the date each subject experienced the event - the subject's start date + 1 day) / (365.25 days). The analysis population for this endpoint was the Safety Population: the Safety Population comprised all subjects who provided informed consent / assent, who were randomized, and who received at least 1 dose or a partial dose of CSL830.
Conditions Studied
Interventions
- BIOLOGICAL C1-esterase inhibitor
Study Locations (20)
California
- Study Site - La Jolla
- Study Site - Orange
- Study Site - Walnut Creek
Ontario
- Study Site - Hamilton
- Study Site - Ottawa
- Study Site - Toronto
Other
- Study Site - Québec
- Study Site - Pilsen
- Study Site - Berlin
Alabama
- Study Site - Birmingham
Arizona
- Study Site - Scottsdale
Maryland
- Study Site - Chevy Chase
Ohio
- Study Site - Cincinnati
Oklahoma
- Study Site - Tulsa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 126 participants |
| Start Date | 2014-12-31 |
| Est. Completion | 2017-09-21 |
| Phase | Phase 3 |
What the finished NCT02316353 record still lists
NCT02316353 is an interventional study that assigns participants to a tested intervention. The registered 126 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (84% lower).
The record links to 1 condition, with Hereditary Angioedema Types I and II appearing as the primary indexed condition, and to 1 intervention - of which C1-esterase inhibitor is the first listed.
NCT02316353 names 20 study sites across 14 states, led by California, Ontario, Other.
Frequently Asked Questions
What is clinical trial NCT02316353 about?
NCT02316353 is a clinical study titled "A Study to Evaluate the Long-term Clinical Safety and Efficacy of Subcutaneously Administered C1-esterase Inhibitor in the Prevention of Hereditary Angioedema". The aim of this study is to assess the long-term safety of C1-esterase inhibitor (C1-INH) in preventing hereditary angioedema (HAE) attacks when it is administered under the skin of subjects with HAE. The safety of participating subjects will be assessed for up to 54 weeks. The long-term efficacy of...
What is the current status of trial NCT02316353?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 126 participants. The study started on 2014-12-31. Estimated completion is 2017-09-21.
What conditions does trial NCT02316353 study?
This clinical trial studies the following conditions: Hereditary Angioedema Types I and II.
What interventions are being tested in trial NCT02316353?
The interventions under investigation include: C1-esterase inhibitor (BIOLOGICAL).
Who is sponsoring clinical trial NCT02316353?
This trial is sponsored by CSL Behring, which has 71 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02316353 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Maryland, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02316353's enrollment target sits among peer trials
126 1603rd of 2000 higher than 396 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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