Efficacy, Safety and Tolerability of Icatibant for the Treatment of HAE

Hereditary Angioedema Clinical Trial

— IHA  

Official title:

Open Label, Multicenter Study to Evaluate Efficacy, Safety and Tolerability of a Self-Administered Subcutaneous Formulation of Icatibant for the Treatment of Acute Attacks of Hereditary Angioedema (IHA)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01457430
• Other study ID #: 2011P001768
• Status: Completed
• Phase: Phase 4
• First received: October 13, 2011
• Last updated: October 17, 2016
• Start date: December 2011
• Est. completion date: April 2014

Study information

• Verified date: October 2016
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The investigators propose a study to evaluate the safety, local tolerability, convenience, and efficacy of self-administered Icatibant for the treatment of acute attacks of hereditary angioedema. The investigators believe that self administration with Icatibant for treatment of an acute attack of angioedema will not change the time to complete or near complete resolution of symptoms compared to treatment with Icatibant in a medical facility.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Males and females at least 18 years of age at the time of informed consent

2. Documented diagnosis of hereditary angioedema Type I or II based on ALL of the following criteria:

• Family and/or medical history

• Characteristic attack manifestations, recurrent attacks

• Historical low C4, normal C1q and either low C1-INH or low C1INH function

3. Women of childbearing potential must use consistently and correctly a highly effective, adequate method of birth control (failure rate less than 1% per year), sexual abstinence or have a vasectomised partner during the duration of the study. Hormonal contraception can be continued if verified by a physician that it doesn't affect the course of hereditary angioedema attacks.

4. Mental and physical condition allowing patients to complete baseline assessment, to self-administer Icatibant and to follow other study procedures.

5. Ability to provide signed written informed consent after all aspects of the study have been explained and discussed with the patient.

Exclusion Criteria:

1. Participation in a clinical therapeutic trial of another investigational medicinal product within the past month (except a previous Icatibant study).

2. Diagnosis of angioedema other than Type I or Type II hereditary angioedema.

3. Evidence of symptomatic coronary artery disease based on medical history, in particular, unstable angina pectoris or severe coronary heart disease.

4. Congestive heart failure (NYHA Class 3 and 4).

5. Stroke within the past 6 months.

6. Treatment with angiotensin converting enzyme inhibitor.

7. Pregnancy and/or breast-feeding.

8. In the opinion of the investigator: mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study.

9. In the opinion of the investigator: unlikely to comply with the protocol, for example, uncooperative attitude, inability to return for follow-up visits, or unlikely to complete the study for any reason.

10. In the opinion of the investigator: inability to complete the patient diary, manage study medication or self-administration of an injection.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Angioedema
• Hereditary Angioedema

Intervention

Drug:
• Icatibant
30 mg subcutaneous dose of Icatibant

Locations

Country	Name	City	State
United States	AARA Research Center	Dallas	Texas
United States	Penn State University	Hershey	Pennsylvania
United States	San Diego Veterans Affairs Medical Center	La Jolla	California
United States	UCLA - David Geffen School of Medicine	Los Angeles	California
United States	Institute for Allergy and Asthma	Wheaton	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Shire Human Genetic Therapies, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to Complete or Near Complete Resolution From Onset of Symptoms	Time of onset of HAE attack, time icatibant was administered, and time to complete relief of symptoms were recorded in minutes. Time to complete relief of symptoms was defined as time from onset of symptoms to complete or near complete resolution as reported by the patient.	Time to complete or near complete resolution of symptoms as reported by the patient, an expected average of 8-10 hours	No
Secondary	Percent Change in VAS Scores	Baseline, 4 hours VAS scale ranges from 0-100 with 0 being the lowest severity and 100 being the highest severity	Percent Change in VAS Score from Baseline to 4 Hours	No