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Efficacy and Safety Study of DX-2930 to Prevent Acute Angioedema Attacks in Patients With Type I and Type II HAE

NCT02586805 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 125

Last updated 2021-06-02

Study results available
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Summary

This is a phase 3, multicenter, randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of DX-2930 in preventing acute angioedema attacks in patients with Type I and Type II HAE.

Conditions

  • Hereditary Angioedema (HAE)

Interventions

DRUG

DX-2930 - 300mg/2wk

300 mg DX-2930 administered every 2 weeks by subcutaneous injection.

DRUG

DX-2930 - 300mg/4wk

300 mg DX-2930 administered every 4 weeks by subcutaneous injection. To maintain the study blind, subjects will be given placebo injections every other 2 weeks when they are not receiving drug.

DRUG

DX-2930 - 150mg/4wk

150 mg DX-2930 administered every 4 weeks by subcutaneous injection. To maintain the study blind, subjects will be given placebo injections every other 2 weeks when they are not receiving drug.

DRUG

Placebo

Placebo administered every 2 weeks by subcutaneous injection.

Sponsors & Collaborators

  • Dyax Corp.

    collaborator INDUSTRY

  • Shire

    lead INDUSTRY

Principal Investigators

  • Shire Physician · Shire

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-03
Primary Completion
2017-04-13
Completion
2017-04-13

Countries

  • United States
  • Canada
  • Germany
  • Italy
  • Jordan
  • Puerto Rico
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

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 NCT02586805 on ClinicalTrials.gov