A Phase III Randomized Double-blind, Placebo-controlled Multicenter Study of Icatibant for Subcutaneous Injection in Patients with Acute Attacks of Hereditary Angioedema (HAE) - FAST-3
- Conditions
- Hereditary angioedema (HAE) in adults patients with C1-esterase inhibitor deficiencyMedDRA version: 12.0Level: LLTClassification code 10019860Term: Hereditary angioedema
- Registration Number
- EUCTR2009-015606-19-LT
- Lead Sponsor
- Jerini US Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 88
Each patient must meet the following criteria to be enrolled in this study:
1) The patient is =18 years old at the time of informed consent.
2) The patient has a documented diagnosis of HAE type I or II. The diagnosis will be confirmed either by documented decreased C4 levels and/or immunogenic or functional C1-INH deficiency results (<50% of normal levels) consistent with HAE types I and II or by medical history. Inclusion will be permitted initially based on medical history alone only if a clear diagnosis has been made using all of the following criteria:
a. Family history
b. Characteristic attack manifestations, recurrent attacks
c. Historical functional C1-INH (<50% of normal levels)
d. Exclusion of other forms of angioedema including acquired angioedema based on normal C1q levels at time of screening.
e. Subsequent confirmation of the diagnosis is to be made by C1-INH level and function, and C1q and C4 results measured in a central laboratory. If there are any discrepancies between the local laboratory results and medical history, the patient can only be included in the efficacy analysis if diagnosis of HAE has been clearly confirmed clinically and a rationale for the functional level of C1-INH =50% of normal can be given; these specific cases are to be discussed with the Sponsor prior to treatment. If there is a discrepancy between C4 and C1-INH levels, the results will be reviewed by the sponsor but C1-INH levels will be used to determine eligibility of the patient.
3) The current HAE attack must be in the cutaneous, abdominal and/or laryngeal (inclusive of laryngeal and pharyngeal) areas.
4) Cutaneous or abdominal HAE attacks must be moderate to very severe as determined by investigator global assessment at pretreatment assessments.
5) The patient must report at least 1 VAS score =30mm.
6) The patient commences treatment within 6 hours of the attack becoming at least mild (laryngeal) or moderate (non-laryngeal) in severity, but not more than 12 hours after the onset of the attack.
7) The patient must have voluntarily signed an Institutional Review Board/Independent Ethics Committee-approved informed consent form after all relevant aspects of the study have been explained and discussed with the patient.
8) Women of childbearing potential must have a negative urine pregnancy test and must use appropriate methods to prevent pregnancy during their participation in the study.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Patients who meet any of the following criteria will be excluded from the study:
1) The patient has a diagnosis of angioedema other than HAE (non-hereditary angioedema, eg, acquired angioedema).
2) The patient has received previous treatment with icatibant.
3) The patient has participated in a clinical trial and has received treatment with another investigational medicinal product within the past 30 days.
4) The patient has received treatment with any pain medication since the onset of the current angioedema attack.
5) The patient has received replacement therapy (fresh frozen plasma [FFP], C1-INH products) less than 5 days (120 hours) from the onset of the current angioedema attack.
6) The patient is receiving treatment with angiotensin converting enzyme (ACE) inhibitors.
7) The patient has evidence of coronary artery disease based on medical history at the Screening examination or at pretreatment; eg, unstable angina pectoris or severe coronary heart disease and congestive heart failure, that in the Investigator’s judgment would be a contraindication for participation in the trial. (New York Heart Association [NYHA] class 3 and 4).
8) The patient has a serious concomitant illness or condition that, in the opinion of the Investigator, would be a contraindication for participation in the trial.
9) The patient is pregnant or breastfeeding.
10) The patient is unable to understand the nature, scope, and possible consequences of the protocol, or is unlikely to comply with the protocol assessments, unable to return for follow up visits, or unlikely to complete the study for any reason.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method