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Treatment of Hereditary Angioedema Prodrome with Recombinant C1-esterase Inhibitor (Ruconest)

NCT06690047 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2024-11-15

No results posted yet for this study

Summary

To assess the efficacy of recombinant human C1-esterase inhibitor in the management of HAE prodrome for preventing the progression from prodrome to an acute angioedema attacks. Subjects will either receive Ruconest after the first 2 prodromes or during the last 2 prodromes. 5 clinic visits will occur within 24 hours of a prodrome. Subjects will complete prodrome severity and angioedema attack diaries

Conditions

Interventions

BIOLOGICAL

Ruconest

recombinant human C1-esterase inhibitor

Sponsors & Collaborators

  • Bernstein Clinical Research Center

    lead OTHER

Principal Investigators

  • Jonathan Bernstein, MD · Bernstein Clinical Research Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-14
Primary Completion
2022-04-28
Completion
2022-04-28
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06690047 on ClinicalTrials.gov