Human C1 Esterase Inhibitor (C1-INH) in Subjects With Acute Abdominal or Facial Hereditary Angioedema (HAE) Attacks

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

126 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-06-30

Study Completion Date

2007-12-31

Brief Summary

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HAE is a rare disorder characterized by functional C1 esterase inhibitor deficiency. If not treated adequately, the acute attacks of HAE can be life-threatening and may even result in fatalities, especially in case of swelling of the larynx. This clinical Phase 2/Phase 3 study was designed to provide clinically relevant data on dosing, efficacy and safety in subjects with HAE.

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Detailed Description

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For each subject, only a single abdominal or facial attack was treated and evaluated. After receiving treatment, subjects were observed for a minimum of 4 hours, after which they could be discharged from the study center if they reported onset of symptom relief. Starting from 4 hours after treatment, subjects who reported insufficient or no symptom relief could receive a second dose of double-blind treatment (called "rescue medication") as follows: C1-INH 20 U/kg bw for subjects initially receiving placebo, C1-INH 10 U/kg bw for subjects initially receiving C1-INH 10 U/kg bw, and placebo for subjects initially receiving C1-INH 20 U/kg bw.

The study was defined to be successful if the primary outcome measure and at least one of the secondary outcome measures were met in the comparison between the C1-INH 20 U/kg bw group and the Placebo group.

Conditions

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Hereditary Angioedema

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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C1-INH 10 U/kg bw

10 Units (U)/kg body weight (bw) dose

Group Type EXPERIMENTAL

C1 Esterase Inhibitor

Intervention Type BIOLOGICAL

Single application of C1-INH administered intravenously by slow injection or infusion at a recommended rate of 4mL/min.

C1-INH 20 U/kg bw

20 U/kg bw dose

Single application of physiological saline solution equivalent to the volume calculated for subjects in the C1-INH 20 U/kg bw arm.

Intervention Type BIOLOGICAL

Other Intervention Names

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Berinert Berinert P CE1145 Physiological saline solution

Eligibility Criteria

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Inclusion Criteria

* Documented congenital C1-INH deficiency
* Acute facial or abdominal HAE attack

Exclusion Criteria

* Acquired angioedema
* Treatment with any other investigational drug within the last 30 days before study entry
* Treatment with any C1-INH concentrate within the previous 7 days

Minimum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No