Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

RECRUITING 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

NCT06361537 · View on ClinicalTrials.gov ↗

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

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

FieldValue
Enrollment Target 124 participants
Start Date 2024-04-30
Est. Completion 2027-06
Phase Phase 3

Sponsor

Octapharma

73 total trials

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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. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. 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 73 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06361537 reports 20 study locations spanning 4 distinct geographic areas — top geographies include Other, Colorado, Michigan. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06361537?

The interventions under investigation include: Placebo (OTHER), OCTA-C1-INH (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06361537?

This trial is sponsored by Octapharma, which has 73 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial