Recombinant Human C1 Inhibitor for the Treatment of Acute Attacks in Patients With Hereditary Angioedema

Pharming Technologies B.V.14 enrolled

Overview

The purpose of this single-center study is to explore the efficacy, safety, tolerability and pharmacokinetics/pharmacodynamics of recombinant human C1 inhibitor in the treatment of acute attacks in patients with hereditary angioedema.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Genetic Disorders

Interventions

i.v. recombinant human C1 inhibitorDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Main inclusion Criteria: * Clinical and laboratory diagnosis of HAE * Plasma level of functional C1INH of less than 50% of normal * Severe attack of abdominal, facial-oro-pharyngeal, genito-urinary and/or peripheral HAE. Main exclusion Criteria: * Acquired angioedema * Pregnancy or breastfeeding * Participation in another clinical study within prior 3 months

Locations (1)

For information contact Sonja Visscher

Leiden, Netherlands

Outcomes

Primary Outcomes

Primary outcomes: Relief of angioedema symptoms

Secondary Outcomes

Secondary outcomes: Safety and tolerability; pharmacokinetics/pharmacodynamics

Data from ClinicalTrials.gov

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