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 multi-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

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Genetic Disorders

Interventions

i.v. recombinant human C1 inhibitorDRUG

Eligibility

Sex: ALLMin age: 16 YearsMax age: 70 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 on sites in Europe, please contact Pharming Technologies.

Leiden, Netherlands

Outcomes

Primary Outcomes

Primary outcomes: Relief of angioedema symptoms

Time frame: 24 hours

Secondary Outcomes

Secondary outcomes: Safety and tolerability; pharmacokinetics/pharmacodynamics

Time frame: 90 days

Data from ClinicalTrials.gov

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