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CSL312 (Garadacimab) in the Prevention of Hereditary Angioedema Attacks

NCT04656418 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2023-06-29

Study results available
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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.

Conditions

Interventions

BIOLOGICAL

CSL312

Fully human immunoglobulin G subclass 4/lambda recombinant monoclonal antibody

DRUG

Placebo

Buffer without active ingredient

Sponsors & Collaborators

  • CSL Behring

    lead INDUSTRY

Principal Investigators

  • Study Director · CSL Behring LLC

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-27
Primary Completion
2022-06-07
Completion
2022-06-07
FDA Drug
Yes

Countries

  • United States
  • Canada
  • Germany
  • Hungary
  • Israel
  • Japan
  • Netherlands

Study Locations

More Related Trials

Entities

Drugs
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 NCT04656418 on ClinicalTrials.gov