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NCT04656418 · ClinicalTrials.gov registry record · Phase 3
CSL312 (Garadacimab) in the Prevention of Hereditary Angioedema Attacks
A Phase 3 study, sponsored by CSL Behring.
- Completed
- Registry status
- Phase 3
- Development phase
- 64
- Enrollment target
NCT04656418: Completed Phase 3 study, sponsored by CSL Behring.
NCT04656418 is a Phase 3 study that has completed, run by CSL Behring. The registered enrollment target is 64 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04656418, a Phase 3 study, has completed, sponsored by CSL Behring.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 64 participants
- Enrollment target
Study Summary
This is a multicenter, double-blind, randomized, placebo-controlled, parallel-arm study to investigate the efficacy and safety of subcutaneous administration of CSL312 (garadacimab) in the prophylactic treatment of hereditary angioedema.
Primary Outcome
Time-normalized number of HAE attacks per month during treatment was calculated per participant as: \[number of HAE attacks / length of participant treatment in days\] \* 30.4375.
Interventions
- DRUG Placebo
- BIOLOGICAL CSL312
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 64 participants |
| Start Date | 2021-01-27 |
| Est. Completion | 2022-06-07 |
| Phase | Phase 3 |
What the finished NCT04656418 record still lists
NCT04656418 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 64 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04656418 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04656418 about?
NCT04656418 is a clinical study titled "CSL312 (Garadacimab) in the Prevention of Hereditary Angioedema Attacks". This is a multicenter, double-blind, randomized, placebo-controlled, parallel-arm study to investigate the efficacy and safety of subcutaneous administration of CSL312 (garadacimab) in the prophylactic treatment of hereditary angioedema.
What is the current status of trial NCT04656418?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 64 participants. The study started on 2021-01-27. Estimated completion is 2022-06-07.
What interventions are being tested in trial NCT04656418?
The interventions under investigation include: Placebo (DRUG), CSL312 (BIOLOGICAL).
Who is sponsoring clinical trial NCT04656418?
This trial is sponsored by CSL Behring, which has 71 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04656418's enrollment target sits among peer trials
64 1799th of 2000 higher than 201 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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