C1 Esterase Inhibitor in Hereditary Angioedema (HAE)(Extension Study)

CSL Behring

Status and phase: Completed; Phase 3

Conditions: Hereditary Angioedema

Treatments: Drug: C1 Esterase Inhibitor

Study type: Interventional

Funder types: Industry

Identifiers

NCT00292981

CE1145_3003

1453 (Other Identifier)

Details and patient eligibility

About

Hereditary angioedema (HAE) is a rare disorder characterized by congenital lack of functional C1 esterase inhibitor. If not treated adequately, the acute attacks of HAE can be life-threatening and may even result in fatalities, especially in case of involvement of the larynx.The planned extension study is designed to enrol subjects that participated in the pivotal study in order to provide them with C1-INH for treatment of acute HAE attacks for 24 months or until the licensing procedure for C1-INH is finalized, whatever comes first.

Enrollment: 57 patients

Sex: All

Ages: 6+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Documented congenital C1-INH deficiency
• Acute HAE attack
• Participation in base study CE1145_3001 (NCT00168103)

Key Exclusion Criteria:

• Acquired angioedema
• Treatment with any other investigational drug besides CE1145 in the last 30 days before study entry

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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57 participants in 1 patient group

C1 Esterase Inhibitor

Experimental group

Treatment:

Drug: C1 Esterase Inhibitor