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NCT06361537 · ClinicalTrials.gov registry record · Phase 3
Study of IV Human Plasma-derived C1 Esterase Inhibitor Concentrate in Patients With Congenital C1-INH Deficiency for Treatment and Pre-procedure Preventing of Acute Hereditary Angioedema Attacks
A Phase 3 study of Acute Hereditary Angio Edema, sponsored by Octapharma.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 124
- Enrollment target
- 20
- Study locations
NCT06361537 is a Phase 3 study of Acute Hereditary Angio Edema that is actively recruiting participants, run by Octapharma. The registered enrollment target is 124 participants. The trial reports 20 study locations across 4 states.
The verdict
NCT06361537, a Phase 3 study of Acute Hereditary Angio Edema, is actively recruiting participants, sponsored by Octapharma.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 124 participants
- Enrollment target
- 20
- Study locations
Study Summary
Prospective, multicenter, randomized, double-blind, parallel group, placebo- controlled, efficacy and safety phase 3 study of an intravenous human plasma- derived C1 esterase inhibitor (C1-INH) concentrate in participants with congenital C1-INH deficiency for the treatment and pre-procedure prevention of acute hereditary angioedema attacks
Conditions Studied
Interventions
- OTHER Placebo
- DRUG OCTA-C1-INH
Study Locations (20)
Other
- Octapharma Research Site - Tirana
- Octapharma Research Site - Rosario
- Octapharma Research Site - Yerevan
- Octapharma Research Site - Sofia
- Octapharma Research Site - Lima
- Octapharma Research Site - Mexico City
- Octapharma Research Site - Podgorica
- Octapharma Research Site - Lima
- Octapharma Research Site - Lima
- Octapharma Research Site - Lima
- Octapharma Research Site - Cluj-Napoca
- Octapharma Research Site - Kragujevac
- Octapharma Research Site - Ankara
- Octapharma Research Site - Istanbul
- Octapharma Research Site - Izmir
- Octapharma Research Site - Sakarya
- Octapharma Research Site - Kyiv
Colorado
- Octapharma Research Site - Centennial
Michigan
- Octapharma Research Site - Farmington Hills
Ohio
- Octapharma Research Site - Toledo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 124 participants |
| Start Date | 2024-04-30 |
| Est. Completion | 2027-06 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06361537
The ClinicalTrials.gov registry entry for NCT06361537 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 124 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Octapharma, which has 43 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Acute Hereditary Angio Edema appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT06361537 reports 20 study locations spanning 4 distinct geographic areas - top geographies include Other, Colorado, Michigan.
Frequently Asked Questions
What is clinical trial NCT06361537 about?
NCT06361537 is a clinical study titled "Study of IV Human Plasma-derived C1 Esterase Inhibitor Concentrate in Patients With Congenital C1-INH Deficiency for Treatment and Pre-procedure Preventing of Acute Hereditary Angioedema Attacks". Prospective, multicenter, randomized, double-blind, parallel group, placebo- controlled, efficacy and safety phase 3 study of an intravenous human plasma- derived C1 esterase inhibitor (C1-INH) concentrate in participants with congenital C1-INH deficiency for the treatment and pre-procedure preventi...
What is the current status of trial NCT06361537?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 124 participants. The study started on 2024-04-30. Estimated completion is 2027-06.
What conditions does trial NCT06361537 study?
This clinical trial studies the following conditions: Acute Hereditary Angio Edema.
What interventions are being tested in trial NCT06361537?
The interventions under investigation include: Placebo (OTHER), OCTA-C1-INH (DRUG).
Who is sponsoring clinical trial NCT06361537?
This trial is sponsored by Octapharma, which has 43 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06361537 being conducted?
This trial has 20 study locations across Colorado, Michigan, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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