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Angioedema clinical trials

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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: NCT04861090 Completed - Clinical trials for Hereditary Angioedema (HAE)

A Study in Teenagers and Adults With Hereditary Angioedema (HAE) Type I or Type II Who Use Lanadelumab as Long-Term Prophylaxis

INTEGRATED
Start date: September 15, 2021
Phase:
Study type: Observational

The main aims of this study are to learn how many people with HAE Type I or Type II are attack-free when treated with lanadelumab in real life. This includes the number of people that are attack-free when lanadelumab is given every 2 and every 4 weeks. This study is about collecting existing data only; participants will not receive lanadelumab as part of this study. No new information will be collected during this study. Only data already available at the participant's doctor's office will be reviewed and collected for this study. Participants do not need to visit their doctor in addition to their normal visits.

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.

NCT ID: NCT04656418 Completed - Clinical trials for Hereditary Angioedema

CSL312 (Garadacimab) in the Prevention of Hereditary Angioedema Attacks

Start date: January 27, 2021
Phase: Phase 3
Study type: Interventional

This is a multicenter, double-blind, randomized, placebo-controlled, parallel-arm study to investigate the efficacy and safety of subcutaneous administration of CSL312 (garadacimab) in the prophylactic treatment of hereditary angioedema.

NCT ID: NCT04654351 Completed - Clinical trials for Hereditary Angioedema

A Study of Icatibant (TAK-667) in Japanese Children and Teenagers With Acute Attacks of Hereditary Angioedema

Start date: January 15, 2021
Phase: Phase 3
Study type: Interventional

The main aim of the study is to check for side effects from icatibant in children and teenagers with hereditary angioedema (HAE). Other aims are to check how well icatibant controls HAE symptoms in these children and teenagers, and how much icatibant stays in their blood. At the first visit, the study doctor will check if each child or teenager can take part. For those who can take part, participants and their parents or caregivers will visit the clinic or hospital when they have their next HAE attack. Participants will receive 1 injection (shot) of icatibant in a vein and will stay at the clinic or hospital until their HAE symptoms are under control. Participants can receive up to 2 more injections of icatibant over time if their HAE symptoms don't improve or get worse. After the participants go home, the study staff will follow up with them by a telephone call 1 to 2 days later. Then, the participants will visit the clinic or hospital 1 week after they received the icatabant injection. The participant can visit the clinic or hospital and be treated with icatibant in the same way for up to 3 HAE attacks in total.

NCT ID: NCT04618211 Completed - Clinical trials for Hereditary Angioedema

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

RAPIDe-1
Start date: February 3, 2021
Phase: Phase 2
Study type: Interventional

This study evaluates the efficacy of orally administered deucrictibant for the acute treatment of attacks in patients with hereditary angioedema (HAE). Eligible subjects are randomized to one of three single doses of deucrictibant and placebo. The study will compare symptom relief (skin pain, skin swelling, abdominal pain) during HAE attacks and safety of each dose of deucrictibant with placebo.

NCT ID: NCT04557319 Completed - Clinical trials for Hereditary Angioedema

Safety and Pharmacokinetics of GNR-038 in Healthy Volunteers

Start date: March 10, 2020
Phase: Phase 1
Study type: Interventional

It is an open-label dose-escalating study in sequential cohorts to assess safety and pharmacokinetics of GNR-038.

NCT ID: NCT04444895 Completed - Angioedema Clinical Trials

A Study of Long-Term Safety and Efficacy of Lanadelumab for Prevention of Acute Attacks of Non-histaminergic Angioedema With Normal C1-Inhibitor

Start date: February 5, 2021
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the long-term safety and efficacy of repeated subcutaneous (SC) administration of lanadelumab in adolescents and adults with non-histaminergic angioedema with normal C1-inhibitor who completed study SHP643-303 (NCT04206605).

NCT ID: NCT04349800 Completed - Clinical trials for Hereditary Angioedema

A Single Dose Safety, Tolerability, Pharmacokinetic and Food Effect Study of KVD900 in Healthy Volunteers

Start date: January 4, 2018
Phase: Phase 1
Study type: Interventional

A safety, tolerability, pharmacokinetic and food effect study of KVD900 in healthy volunteers.

NCT ID: NCT04318483 Completed - Milk Allergy Clinical Trials

Characteristic and Evolution of an Atypical IgE-mediated Cow Milk Allergy Form With Hands and Feet Angio-oedema

IgE-CMA
Start date: May 4, 2020
Phase:
Study type: Observational

Cow milk allergy is one of the most frequent food allergy among children. Cow milk protein's avoidance is needed until spontaneous recovery during the two first years of life. A atypical clinical form with angio-oedema of hands and feet which is associated with high rate of lactoserum's IgE might be a hope of an earlier recovery.