Subcutaneous Treatment With Icatibant for Acute Attacks of Hereditary Angioedema

Shire

Status and phase: Completed; Phase 3

Conditions: Angioedema

Treatments: Drug: Icatibant; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00097695

FAST1 (Other Identifier)

JE049 #2103

Details and patient eligibility

About

The purpose of this study is to assess the efficacy and safety of Icatibant, a bradykinin antagonist in the treatment of acute cutaneous and/or abdominal attacks in patients with hereditary angioedema (HAE).

Full description

This Phase II/III study consisted of two parts: A controlled phase and An Open label extension(OLE) phase. The controlled phase describes the double blind part of the study and was intended to evaluate the efficacy of icatibant in decreasing the time to onset of symptom relief compared with placebo for the first treated cutaneous and/or abdominal attack in randomised patients. Patients experienced a laryngeal attack were not randomised, but treated with open label icatibant according to the controlled phase procedures and assessments. The outcome of this group was to be reported descriptively. After treatment of the first attack in the controlled phase, the patients were eligible to enter the OLE phase. In the OLE phase, patients who experienced angioedema attacks severe enough to warrant treatment were to be treated with s.c. icatibant as appropriate until the end of the study.The OLE phase became a modified open label extension where all 56 patients who had been randomised and the last randomised patient had concluded the double-blind phase. The modified open label extension period permitted treatment for patients who were screened and found eligible but did not experience an angioedema attack, or had an attack that was not severe enough to merit treatment while the double blind phase was still ongoing.

Enrollment: 84 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age above 18 years;
• Documented diagnosis of HAE Type I or II (confirmed complement 1 esterase inhibitor [C1-INH] deficiency);
• Current edema be in the cutaneous, abdominal and/or laryngeal areas;
• Current edema be moderate to severe according to the investigator's Symptom Score.

Exclusion criteria

• Diagnosis of angioedema other than HAE, for example, acquired angioedema (AAE);
• Participation in a clinical trial of another investigational medicinal product (IMP) within the past month;
• Treatment with any pain medication since onset of the current edema attack;
• Treatment with replacement therapy, including C1-INH products (e.g. human C1-INH preparations), less than 3 days from onset of the current edema attack;
• Treatment with ACE inhibitors (e.g. Lotensin, Prinivil, Accupril);
• Evidence of severe, symptomatic coronary artery disease based on medical history or screening examination;
• Serious concomitant illnesses that the physician considers to be a contraindication for participation in the trial;
• Pregnancy and/or breast-feeding.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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84 participants in 4 patient groups, including a placebo group

Icatibant- Randomized

Experimental group

Description:

Patients who were randomized to icatibant in the controlled phase after they had an eligible first in-study attack.

Treatment:

Drug: Icatibant

Placebo-Randomized

Placebo Comparator group

Description:

Patients who were randomized to placebo in the controlled phase after they had an eligible first in-study attack.

Treatment:

Drug: Placebo

Controlled Open-label / laryngeal attack

Experimental group

Description:

Patients with laryngeal symptoms at the baseline were not randomised but treated with icatibant open label during the controlled phase.

Treatment:

Drug: Icatibant

Untreated Patients at the baseline

Experimental group

Description:

Patients who were screened and found eligible but did not experience an angioedema attack, or had an attack that was not severe enough to merit treatment while the controlled phase was ongoing (they were not treated during the Controlled phase but treated with icatibant during the Open Label Extension Phase (OLE) )

Treatment:

Drug: Icatibant