Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Recruiting Phase 3 study of Acute Hereditary Angio Edema, sponsored by Octapharma.
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, 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 4 states. According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
Patient will rate symptom relief for the defining attack site (site of swelling or pain) from 15 minutes after start of the IMP injection every 15 minutes over 4 hours. Unequivocal relief is defined as having 3 consecutive reports of "absent now but present before," "absent now and absent before", or "present, symptoms better" on the 5-grade SRRS. This measure will also be used for the secondary outcomes in a different context.
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 |
What NCT06361537 shows while recruiting
NCT06361537 is an interventional study that assigns participants to a tested intervention. The registered 124 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 Acute Hereditary Angio Edema appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT06361537 names 20 study sites across 4 states, led by 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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06361537's enrollment target sits among peer trials
124 1611th of 2000 higher than 386 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02523014 · 124 participants · Phase 2
Vismodegib, FAK Inhibitor GSK2256098, Capivasertib, and Abemaciclib in Treating Patients With Progressive Meningiomas
- NCT02670707 · 124 participants · Phase 3
Vinblastine/Prednisone Versus Single Therapy With Cytarabine for Langerhans Cell Histiocytosis (LCH)
- NCT02830724 · 124 participants · Phase 1
Administering Peripheral Blood Lymphocytes Transduced With a CD70-Binding Chimeric Antigen Receptor to People With CD70 Expressing Cancers
- NCT04748809 · 124 participants · NA
Effect of Anti-inflammatory Diet in Rheumatoid Arthritis
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI