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

NCT ID: NCT00262288

Last Updated: 2013-02-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-04-30

Study Completion Date

2007-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Genetic Disorders

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Recombinant Human C1INH

Group Type EXPERIMENTAL

i.v. recombinant human C1 inhibitor

Intervention Type DRUG

Interventions

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i.v. recombinant human C1 inhibitor

Intervention Type DRUG

Other Intervention Names

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rhC1INH

Eligibility Criteria

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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.

Exclusion Criteria

* Acquired angioedema
* Pregnancy or breastfeeding
* Participation in another clinical study within prior 3 months
Minimum Eligible Age

16 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pharming Technologies B.V.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jan Nuijens, MD, PhD

Role: STUDY_CHAIR

Pharming Technologies B.V.

Locations

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For information on sites in Europe, please contact Pharming Technologies.

Leiden, , Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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C1 1203-01

Identifier Type: -

Identifier Source: org_study_id

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