Hereditary Angioedema (HAE)
Conditions
Interventions
Product Name: Icatibant acetate solution for injection 10 mg/ml
Product Code: JE049
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Icatibant Acetate
CAS Number: 138614-30-9
Current S
Sponsors
Jerini AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • • Age >= 18 years; • Documented diagnosis of HAE Type I or II (confirmed by medical history and/ or immunogenic or functional C1-INH deficiency. Inclusion will be permitted initially based on medical history alone if a clear diagnosis has been made on all of the following criteria: ? Family history; ? Characteristic attack manifestations, recurrent attacks; ? Historical functional C1-INH level 50% can be given; • Current angioedema attack must be in the cutaneous, abdominal and/or laryngeal areas; • Current attack must be moderate to very severe; • Able to complete baseline assessments, and commence treatment no later than 6 hours after the time the current attack becomes moderate; • Women of childbearing potential must have a negative urine pregnancy test and for the duration of the study must use consistently and correctly a highly effective method of birth control (failure rate less than 1% per year), such as implants, injectibles, combined oral contraceptives, reliable intrauterine devices (IUDs), sexual abstinence or vasectomised partner; • Signed written Informed Consent given. Patients with abdominal and/or cutaneous symptoms only: • VAS (Visual Analogue Scale) for primary symptoms (abdominal pain, or cutaneous pain or swelling) at time of randomization >=30 mm 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
Exclusion criteria
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 angioedema attack; • Treatment with replacement therapy, including C1-INH products, less than 3 days before onset of the current angioedema attack; • Treatment with tranexamic acid therapy within a week before onset of the current angioedema attack; • Treatment with ACE inhibitors; • Contraindication for tranexamic acid, i.e. known hypersensitivity to tranexamic acid or any of the ingredients, severe renal failure, active thromboembolic disease, massive bleeding in upper urinary tract, impaired colour vision. • Evidence of coronary artery disease based on medical history or screening examination, in particular unstable angina pectoris or severe coronary heart disease. • Congestive heart failure (class 3 and 4) • Serum creatinine level of > 250µmol/l (>2.82mg/dl) • Serious concomitant illnesses that the physician considers to be a contraindication for participation in the trial; • Pregnancy and/or breast-feeding; • Mental condition rendering the patients, in the opinion of the investigator, unable to understand the nature, scope and possible consequences of the study; • 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to assess the efficacy of a single treatment (consisting of 1 subcutaneous administration) with the Bradykinin (BK) antagonist Icatibant compared with oral tranexamic acid on the onset of relief of symptoms during moderate to very severe acute cutaneous and/or abdominal angioedema attacks in patients with HAE;Secondary Objective: To assess the following parameters of s.c. icatibant compared with oral tranexamic acid in subjects with HAE suffering from cutaneous and/or abdominal oedema attacks: • the rate of response, • time to almost complete relief, • global outcome, • severity of each symptom, • safety • and tolerability ;Primary end point(s): Primary efficacy endpoint: • time to onset of symptom relief assessed by the patient using a VAS scale. For the cutaneous cohort, the time to onset of symptom relief will be assessed based on 'cutaneous swelling' or 'pain (skin)', taking the most severe. If both are equally severe 'pain' is used. For the abdominal cohort of patients, the time to onset of symptom relief will be assessed based on abdominal pain | — |
Countries
Germany, Hungary, Ireland, Italy, Lithuania, Sweden, United Kingdom
Outcome results
None listed