MedTrace Logo

A Phase 2 HAE Prophylaxis Study With Recombinant Human C1 Inhibitor

NCT02247739 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2017-12-08

Study results available
· View outcomes & findings →

Summary

Primary Objective:

To evaluate the efficacy of recombinant human C1 inhibitor (rhC1INH) in the prophylaxis of angioedema attacks in patients with HAE

Secondary Objective:

To evaluate the safety and immunogenicity of recombinant human C1 inhibitor (rhC1INH) in the prophylaxis of angioedema attacks in patients with HAE

Conditions

Interventions

BIOLOGICAL

Recombinant human C1 inhibitor

OTHER

Placebo

Sponsors & Collaborators

  • Pharming Technologies B.V.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
13 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-12-31
Primary Completion
2016-05-31
Completion
2016-09-30

Countries

  • United States
  • Canada
  • Czechia
  • Italy
  • North Macedonia
  • Romania
  • Serbia

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 NCT02247739 on ClinicalTrials.gov