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Angioedema clinical trials

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NCT ID: NCT05509569 Recruiting - Clinical trials for Hereditary Angioedema (HAE)

A Survey of Icatibant in Pediatric Participants With Hereditary Angioedema

Start date: August 24, 2022
Phase:
Study type: Observational

This study is a survey in Japan of Icatibant subcutaneous injection 30 mg syringe used to treat children or teenagers with acute attacks of hereditary angioedema (HAE). The study sponsor will not be involved in how the participants are treated but will provide instructions on how the clinics will record what happens during the study. The main aim of the study is to check for side effects related from Icatibant subcutaneous injection 30 mg syringe and to check if Icatibant subcutaneous injection 30 mg syringe improves acute attacks of HAE. During the study, pediatric participants with HAE will take Icatibant subcutaneous injection 30mg syringe according to their clinic's standard practice. The study doctors will check for side effects from Icatibant subcutaneous injection 30 mg syringe for 3 months.

NCT ID: NCT05505916 Recruiting - Clinical trials for Hereditary Angioedema

An Open-label Extension Trial to Evaluate the Long-term Safety of KVD900 for On-Demand Treatment of Angioedema Attacks in Adolescent and Adult Patients With Hereditary Angioedema (HAE)

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

This is an open-label, multicenter extension trial to evaluate the long-term safety of KVD900 in patients who are 12 years or older with HAE type I or II.

NCT ID: NCT05489640 Recruiting - Clinical trials for Hereditary Angioedema (HAE)

A Study in Adults With Hereditary Angioedema (HAE) Who Currently Receive Icatibant at Home

Start date: November 18, 2022
Phase:
Study type: Observational

The main aim of this study is to describe the treatment patterns, characteristics and outcomes of people with HAE who are currently receiving icatibant in the homecare setting in the United Kingdom (UK). Participants will be treated with icatibant according to their routine practice via homecare service for icatibant within the UK. Data will be directly collected from participants via study diaries and questionnaires. Participants will be contacted approximately every 90 days during study duration (this can occur via phone or as a face-to-face visit).

NCT ID: NCT05469789 Recruiting - Clinical trials for Hereditary Angioedema (HAE)

A Study of Lanadelumab in Teenagers and Adults With Hereditary Angioedema (HAE)

Start date: June 29, 2023
Phase:
Study type: Observational

The main aim of this study is to compare the HAE attack rate requiring on-demand treatment before and within 2 years after participants with HAE have been treated with lanadelumab. This study is conducted in the United Kingdom where participants were treated or about to be treated with landelumab according to their routine practice at hospitals. Data will be directly collected from participants via study diaries, questionnaires, their medical records, and study doctors treating them. Participants will be contacted every 3 months during study participation (via phone).

NCT ID: NCT05397431 Recruiting - Clinical trials for Hereditary Angioedema (HAE)

A Survey of Lanadelumab in Participants With Hereditary Angioedema

Start date: May 30, 2022
Phase:
Study type: Observational

This study is a survey in Japan of Lanadelumab used to treat people with hereditary angioedema (HAE). The study sponsor will not be involved in how the participants are treated but will provide instructions on how the clinics will record what happens during the study. The main aim of the study is to check for side effects related from Lanadelumab and to check if Lanadelumab improves symptoms of HAE. During the study, participants with HAE will take Lanadelumab subcutaneous injection according to their clinic's standard practice. The study doctors will check for side effects from Lanadelumab for 12 months.

NCT ID: NCT05396105 Recruiting - Clinical trials for Hereditary Angioedema

Extension Study of Oral PHA-022121 for Acute Treatment of Angioedema Attacks in Patients With Hereditary Angioedema

RAPIDe-2
Start date: December 28, 2022
Phase: Phase 2/Phase 3
Study type: Interventional

This study evaluates the safety and efficacy of long-term on-demand treatment with orally administered deucrictibant for acute hereditary angioedema (HAE) attacks, including laryngeal attacks, in patients with HAE due to C1-esterase inhibitor (C1-INH) deficiency (type I/II). The study will enroll patients from Study PHA022121-C201 (NCT04618211) who elect to participate in this extension study and meet the eligibility requirements.

NCT ID: NCT05392114 Recruiting - Clinical trials for Hereditary Angioedema

A Study to Assess the Long-Term Safety and Efficacy of Donidalorsen in the Prophylactic Treatment of Hereditary Angioedema (HAE)

Start date: July 13, 2022
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the long-term safety and efficacy of donidalorsen in people with HAE and the effects of donidalorsen on the number of HAE attacks and their impact on quality of life (QoL).

NCT ID: NCT05147181 Recruiting - Clinical trials for Hereditary Angioedema (HAE)

A Study With Lanadelumab in Persons With Hereditary Angioedema (HAE) in Poland

CHOPIN
Start date: March 11, 2022
Phase:
Study type: Observational

The main aim of this study is to learn about how many persons with HAE type I or type II are attack-free when treated with lanadelumab in real life, how many attacks occur and how many of these attacks need rescue treatment and about the nature of HAE attacks. Participants will need to visit their doctor 5 times in total as part of this study. The visits are planned every 6 months. Participants will also be asked to fill out questionnaires as part of this study.

NCT ID: NCT05121376 Recruiting - Clinical trials for Hereditary Angioedema

A Gene Therapy Study of BMN 331 in Subjects With Hereditary Angioedema

HAErmony-1
Start date: February 15, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

This is a Phase 1/2, single-arm, open-label, dose-escalation and dose-expansion study of BMN 331 for the treatment of hereditary angioedema (HAE) due to C1 Esterase Inhibitor (C1-INH) protein deficiency. The study drug BMN 331is identified as AAV5 hSERPING1, an adeno-associated virus (AAV5)-based gene therapy vector that expresses wild-type human C1 Esterase Inhibitor (hC1-INH), under the control of a liver-selective promoter, and is being developed for the treatment of HAE with C1-INH deficiency. The pharmaceutical form of BMN 331 is a solution for intravenous infusion.

NCT ID: NCT04963634 Recruiting - Angio Edema Clinical Trials

Research of Biomarkers Associated With the Diagnosis and Severity of Bradykinin Angioedema

BRADYDIAG
Start date: January 22, 2022
Phase:
Study type: Observational

The unpredictable nature of the attacks is one of the essential characteristics of bradykinin angioedema. The two main difficulties for physicians managing a patient with bradykinin angioedema are to make the diagnosis and anticipate the severity. Biomarkers can be used to diagnose, guide treatment, or predict the severity of a disease. However, the identification of biomarkers is currently difficult in bradykinin both for diagnosis and prognosis. While measurement of C4 and C1 inhibitor (quantitative and functional assays) allows the diagnosis of bradykinin angioedema due to C1 inhibitor deficiency, whether genetic or acquired, many patients with normal C1 inhibitor bradykinin angioedema, either hereditary or acquired, are still difficult to diagnose. For patients with hereditary angioedema with C1-inhibitor deficiency, there is no biomarker currently available to predict the severity. Any biomarker that could improve the diagnosis on the one hand, and improve the prediction of the frequency and severity of the response to treatment on the other hand, would obviously be extremely useful. The aim of our study is to assess the existence possible biomarkers for diagnosis and prognosis of bradykinin angioedema.