Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2025-12-24 @ 11:33 PM
NCT ID:
NCT00500656
Eligibility Criteria:
Inclusion Criteria:
* Age above 18 years;
* Documented diagnosis of HAE Type I or II (confirmed C1-INH deficiency);
* Current edema in the cutaneous, abdominal and/or laryngeal areas;
* Current edema moderate to severe according to the investigator's Symptom Score.
Exclusion Criteria:
* Diagnosis of angioedema other than HAE,
* 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 replacement therapy within a week before onset of the current angioedema attack
* Treatment with ACE inhibitors
* Contraindications for Tranexamic acid
* 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 ≥ 250 μmol/L
* Serious concomitant illness that the investigator considered to be a contraindication for participation in the trial
* Pregnancy (as assessed prior to treatment) and/or breast-feeding
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00500656
Study Brief:
Protocol Section:
NCT00500656