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Hereditary Angioedema clinical trials

View clinical trials related to Hereditary Angioedema.

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NCT ID: NCT06414252 Completed - Clinical trials for Hereditary Angioedema

Social Evaluated Cold Pressor Test in Hereditary Angioedema Patients

FROSEN
Start date: May 15, 2023
Phase:
Study type: Observational

This study aims to evaluate the differences in objective and subjective stress responses between patients with hereditary angioedema and healthy individuals to a stress-induced challenge like socially-evaluated cold pressure test. The study also investigates the role of psychological variables in influencing the stress response.

NCT ID: NCT06408805 Completed - Clinical trials for Hereditary Angioedema

Autonomic Nervous System Profile in Hereditary Angioedema

ANS-HAE
Start date: July 12, 2023
Phase:
Study type: Observational

The goal of this study is to compare the autonomic nervous system control of patients with hereditary angioedema to healthy individuals. The main questions it aims to answer are: Are there differences in the autonomic nervous system control between patients with hereditary angioedema and healthy individuals during short-term resting period and during orthostatic challenges? Are there differences in the autonomic nervous system control recorded over long-term periods (i.e. 24 hours)?

NCT ID: NCT05477160 Completed - Clinical trials for Hereditary Angioedema

A Study of STAR-0215 in Healthy Adult Participants

Start date: July 27, 2022
Phase: Phase 1
Study type: Interventional

This is a first-in-human, single-center, randomized, double-blind, placebo-controlled, single ascending dose study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of a single subcutaneous (SC) or intravenous (IV) administration of STAR-0215 in healthy adult participants.

NCT ID: NCT05259917 Completed - Clinical trials for Hereditary Angioedema

A Phase III, Crossover Trial Evaluating the Efficacy and Safety of KVD900 for On-Demand Treatment of Angioedema Attacks in Adolescent and Adult Patients With Hereditary Angioedema (HAE)

Start date: February 23, 2022
Phase: Phase 3
Study type: Interventional

This study is a randomized, double-blind, placebo-controlled, phase III, three-way crossover clinical trial evaluating the efficacy and safety of KVD900, in the treatment of hereditary angioedema attacks in adolescent and adult Patients

NCT ID: NCT05178355 Completed - Clinical trials for Hereditary Angioedema

A Single and Multiple Doses Safety, Tolerability, Pharmacokinetics and Food Effect Study of KVD824 in Healthy Volunteers

Start date: February 12, 2019
Phase: Phase 1
Study type: Interventional

This is a 3 part phase 1, randomized, double-blind, placebo-controlled, study of the safety, tolerability, and pharmacokinetics of KVD824 following administration of single and multiple ascending oral doses; followed by a crossover food effect sub-study in healthy male volunteers.

NCT ID: NCT05139810 Completed - Clinical trials for Hereditary Angioedema

OASIS-HAE: A Study to Evaluate the Safety and Efficacy of Donidalorsen (ISIS 721744 or IONIS-PKK-LRx) in Participants With Hereditary Angioedema (HAE)

Start date: December 3, 2021
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the safety and efficacy of donidalorsen in participants with HAE and effect of donidalorsen on the quality and pattern of HAE attacks and their impact on quality of life (QoL).

NCT ID: NCT05118958 Completed - Clinical trials for Hereditary Angioedema

Phase 1 Crossover Study in Healthy Subjects to Evaluate the PK Profile of KVD824 Following Single and Multiple Doses of Modified Release (MR) Formulations

Start date: May 19, 2020
Phase: Phase 1
Study type: Interventional

This is a 3 part, phase 1 crossover study in healthy subjects to evaluate the pharmacokinetic profile of KVD824 following single and multiple doses of novel KVD824 modified-release formulations compared with a reference KVD824 immediate release formulation.

NCT ID: NCT04957641 Completed - Clinical trials for Hereditary Angioedema

A Study of the Burden of Illness and Treatment Patterns in Teenagers and Adults With Hereditary Angioedema

BOISTERN
Start date: April 21, 2022
Phase:
Study type: Observational

This study is about teenagers and adults with hereditary angioedema (HAE) type I and type II. In this study, the burden of illness means the impact of HAE in terms of long-term health outcomes and the financial cost. The main aims of this study are as follows: - to learn how often, how severe and where on the body HAE attacks occur. - to describe how HAE prophylaxis and on-demand medicines are prescribed and used. (Prophylaxis medicines prevent a bleed from happening and on-demand medicines treat a bleed when it occurs.) This study is about collecting data only; participants will not receive treatment as part of this study. Existing data available in the participant's medical records will be collected. Participants will be asked to complete an electronic questionnaire either on a website or by using an app on their mobile phone; data from this questionnaire will also be collected. Participants do not need to visit their doctor in addition to their normal visits.

NCT ID: NCT04888650 Completed - Clinical trials for Hereditary Angioedema

Assessment of the State of Health, Quality of Life and Expectations of Patients With Hereditary Angioedema

BESQAOH
Start date: May 3, 2021
Phase:
Study type: Observational

8 years after the establishment of the therapeutic education program and 14 years after the creation of the National Reference Center for Angioedemas (CREAK), it is necessary to make an inventory in 2021 on the disease experienced by the patient with an assessment the needs and expectations of HAE patients. This assessment would make it possible to see the evolution of these needs and to adjust the price for the overall cost of children and adults in France. It may also allow a comparison of the requests expressed during a similar survey in another French-speaking region such as Quebec. Main objective is to know the needs and the current satisfaction of the needs, with regard to the disease and the treatment of the targeted patients of hereditary angioedema (HAE)

NCT ID: NCT04687137 Completed - Clinical trials for Hereditary Angioedema

Expanded Access Program With Lanadelumab for Japanese People With Hereditary Angioedema

Start date: February 10, 2021
Phase: Phase 3
Study type: Interventional

The expanded access program allows people to gain access to an unlicensed treatment on compassionate grounds. Lanadelumab, also known as TAK-743, is a medicine to help prevent hereditary angioedema attacks. Lanadelumab is not yet licensed for use in Japan. The main aim of this study is to allow Japanese teenagers and adults with type I or type II hereditary angioedema to be treated with lanadelumab, through the expanded access program in Japan. Participants can either have taken part in the previous study SHP643-302 or can be new participants. Participants just completing study SHP643-302 who reach the criteria can automatically take part in this study. However, for new participants, the study doctor will check who can take part at the first study visit. For those who can take part, new participants will receive injections of lanadelumab just under the skin. Eventually, after training, some of these will be able to inject themselves with lanadelumab in the same way. Participants who injected themselves with lanadelumab in study SHP643-302 can continue to do so during this study. The study doctors will decide if each participant will be treated with lanadelumab every 2 weeks or every 4 weeks. Treatment with lanadelumab will continue until lanadelumab is commercially available in Japan or the sponsor (Takeda) stops the study. Participants can visit the clinic during treatment if needed. If treatment continues after 6 months, participants will visit the clinic every 12 weeks for a check-up. This will include noting any hereditary angioedema attacks and side effects from the treatment. After 7 months of treatment, the study staff will check-up with each participant every 2 weeks by telephone. After treatment has finished, participants will visit the clinic for a final-check-up 4 weeks later.