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Clinical Trials/NCT00262288
NCT00262288
Completed
Phase 2

A Phase II/III Study of the Efficacy and Safety of Recombinant Human C1 Inhibitor for the Treatment of Acute Attacks in Patients With Hereditary Angioedema

Pharming Technologies B.V.1 site in 1 country14 target enrollmentApril 2004
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ConditionsGenetic Disorders
Interventionsi.v. recombinant human C1 inhibitor
Drugsi.v. recombinant human C1 inhibitor

Overview

Phase
Phase 2
Intervention
i.v. recombinant human C1 inhibitor
Conditions
Genetic Disorders
Sponsor
Pharming Technologies B.V.
Enrollment
14
Locations
1
Primary Endpoint
Primary outcomes: Relief of angioedema symptoms
Status
Completed
Last Updated
13 years ago
OverviewInvestigatorsEligibility CriteriaArms & InterventionsOutcomesSitesSimilar Trials

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
April 2004
End Date
January 2007
Last Updated
13 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Arms & Interventions

Recombinant Human C1INH

Intervention: i.v. recombinant human C1 inhibitor

Outcomes

Primary Outcomes

Primary outcomes: Relief of angioedema symptoms

Time Frame: 24 hours

Secondary Outcomes

  • Secondary outcomes: Safety and tolerability; pharmacokinetics/pharmacodynamics(90 days)

Study Sites (1)

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