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

NCT ID: NCT00261053

Last Updated: 2013-04-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-06-30
• Study Completion Date: 2005-12-31

Brief Summary

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.

Conditions

Genetic Disorders

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Open-label i.v. administration of 100 U/kg rhC1INH

Group Type: OTHER

i.v. recombinant human C1 inhibitor

Intervention Type: DRUG

Interventions

i.v. recombinant human C1 inhibitor

Intervention Type: DRUG

Eligibility Criteria

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: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pharming Technologies B.V.

INDUSTRY

Sponsor Role: lead

Principal Investigators

Jan Nuijens, MD, PhD

Role: STUDY_CHAIR

Pharming Technologies B.V.

Locations

For information contact Sonja Visscher

Leiden, , Netherlands

Countries

Netherlands

Other Identifiers

C1 1202-01

Identifier Type: -

Identifier Source: org_study_id