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

Pharming Healthcare

Status and phase: Completed; Phase 3; Phase 2

Conditions: Genetic Disorders

Treatments: Drug: i.v. recombinant human C1 inhibitor

Study type: Interventional

Funder types: Industry

Identifiers

NCT00262288

C1 1203-01

Details and patient eligibility

About

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.

Enrollment: 14 patients

Sex: All

Ages: 16 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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14 participants in 1 patient group

Recombinant Human C1INH

Experimental group

Treatment:

Drug: i.v. recombinant human C1 inhibitor