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Angioedema clinical trials

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NCT ID: NCT06361537 Recruiting - Clinical trials for Acute Hereditary Angio Edema

Study of IV Human Plasma-derived C1 Esterase Inhibitor Concentrate in Patients With Congenital C1-INH Deficiency for Treatment and Pre-procedure Preventing of Acute Hereditary Angioedema Attacks

Start date: April 30, 2024
Phase: Phase 3
Study type: Interventional

Prospective, multicenter, randomized, double-blind, parallel group, placebo- controlled, efficacy and safety phase 3 study of an intravenous human plasma- derived C1 esterase inhibitor (C1-INH) concentrate in participants with congenital C1-INH deficiency for the treatment and pre-procedure prevention of acute hereditary angioedema attacks

NCT ID: NCT06343779 Recruiting - Clinical trials for Hereditary Angioedema

Study of Oral Deucrictibant Soft Capsule for On-Demand Treatment of Angioedema Attacks in Adolescents and Adults With Hereditary Angioedema

RAPIDe-3
Start date: February 26, 2024
Phase: Phase 3
Study type: Interventional

This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled, 2-period, 2-treatment cross-over study to evaluate the efficacy and safety of orally administered deucrictibant compared to placebo for the on-demand treatment of HAE attacks, including non-severe laryngeal attacks, in participants ≥12 to ≤75 years of age with HAE type 1 or type 2 (HAE-1/2), a proportion of whom are using long-term prophylactic medication for HAE.

NCT ID: NCT05936567 Recruiting - Clinical trials for Chronic Spontaneous Urticaria

Study Evaluating the Efficacy and Safety of Povorcitinib in Adults With Chronic Spontaneous Urticaria

Start date: July 31, 2023
Phase: Phase 2
Study type: Interventional

This study is being conducted to evaluate the efficacy and safety of povorcitinib in adults with CSU that is inadequately controlled using SOC treatments.

NCT ID: NCT05904301 Recruiting - Clinical trials for Rheumatoid Arthritis

Armenian NAtionwide REGistry of Systemic Autoimmune and Autoinflammatory Diseases

NAREG
Start date: June 21, 2023
Phase:
Study type: Observational

Longitudinal prospective multicenter Armenian registry of systemic autoimmune, autoinflammatory diseases with constitution of bio-banking.

NCT ID: NCT05819775 Recruiting - Clinical trials for Hereditary Angioedema (HAE)

CSL312_3003 Safety and Pharmacokinetic Study in Subjects 2 to 11 Years of Age With Hereditary Angioedema

Start date: May 30, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this study is to investigate the safety, PK / PD, and efficacy of SC CSL312 for prophylactic treatment of pediatric subjects with HAE.

NCT ID: NCT05776784 Recruiting - Clinical trials for Angio Edema Hereditary

Status of Dental Care Practices in Patients With Hereditary Angioedema

PRADA
Start date: February 27, 2023
Phase:
Study type: Observational

Hereditary angioedema (HAE) is a rare genetic disease, it can occur at any age and evolves in flare-ups. These are subcutaneous or submucosal edemas responsible for tightness and pain. All areas can be reached. In addition, all their life, patients have an unpredictable risk of death from asphyxiating angioedema (25% mortality in the absence of specific treatment). Surgical procedures, endoscopies and dental procedures can trigger laryngeal AE. Thus, the national reference center for angioedema (CREAK) and the latest international consensus1 recommend that all these procedures be preceded by short-term prophylaxis. The reference treatment is the C1 inhibitor 2 concentrate. But to date, there is no prospective study that has demonstrated the effectiveness of this short-term prophylaxis before dental treatment. Only a retrospective study has shown that its implementation made it possible to reduce the risk of crisis by 42% after tooth extraction 3 and that the risk of crisis was greatest within 8 hours following tooth extraction. The C1 inhibitor concentrate must be administered IVL by a nurse within 6 hours before the procedure and therefore implies, in addition to its high cost (1500 €), an organizational burden for the patient who must plan for the passage of an IDE, the availability of the product and this sometimes for a simple dental treatment. These constraints have two consequences for dental care: patients avoid going to the dentist to the detriment of their dental health or do not take prophylaxis with the risk of a fatal attack.

NCT ID: NCT05695248 Recruiting - Clinical trials for Hereditary Angioedema

A Study of STAR-0215 in Participants With Hereditary Angioedema

Start date: February 21, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

The goal of this clinical trial is to test the drug STAR-0215 in participants with hereditary angioedema (HAE). One group of participants will get 1 dose of STAR-0215, and two other groups will get 2 doses of STAR-0215. Researchers will study the effects of STAR-0215 in participants with HAE as this is the first time that the drug has been given to participants with HAE.

NCT ID: NCT05691361 Recruiting - Clinical trials for Hereditary Angioedema

Safety, Tolerability, PK, PD of ADX-324 in Healthy Volunteers and Hereditary Angioedema Patients

Start date: December 14, 2022
Phase: Phase 1
Study type: Interventional

The first-in-human Phase 1 study will evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of ADX-324 in healthy volunteers (HV) and in patients with Hereditary Angioedema (HAE).

NCT ID: NCT05578417 Recruiting - Clinical trials for Hereditary Angioedema (HAE)

A Study to Review the Treatment and Outcomes of Teenagers and Adults With Non-histaminergic Angioedema With Normal C1 Inhibitor in Canada

PROSPECT
Start date: June 15, 2023
Phase:
Study type: Observational

The main aim of this study is to describe the characteristics of participants, check for number of hereditary angioedema (HAE) cases, their treatment and outcomes. Another aim is to check how the healthcare facilities were utilized for treatment. Participants' data will be taken from their medical records (charts), which were already collected as a part of their routine care between January 1, 2012, and January 1, 2022.

NCT ID: NCT05511922 Recruiting - Clinical trials for Hereditary Angioedema

PK Subtrial in Adolescent Patients With HAE Type I or II Participating in the KVD900-302 Trial

Start date: October 24, 2022
Phase: Phase 3
Study type: Interventional

This is a multicenter pharmacokinetic (PK) subtrial to investigate the PK profile of KVD900 in adolescent patients 12 to 17 years of age with Hereditary Angioedema (HAE) type I or II.