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Hereditary Angioedema (HAE) clinical trials

View clinical trials related to Hereditary Angioedema (HAE).

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NCT ID: NCT05460325 Completed - Clinical trials for Hereditary Angioedema (HAE)

A Study of Lanadelumab (SHP643) in Chinese Participants With Hereditary Angioedema (HAE)

Start date: June 22, 2022
Phase: Phase 3
Study type: Interventional

The main aim of this study is to evaluate the safety of lanadelumab in Chinese participants with HAE. Participants will be treated with lanadelumab for 26 weeks.

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: NCT04180163 Completed - Clinical trials for Hereditary Angioedema (HAE)

Efficacy and Safety of Lanadelumab (SHP643) in Japanese Participants With Hereditary Angioedema (HAE)

Start date: December 12, 2019
Phase: Phase 3
Study type: Interventional

The purpose of this phase 3, open-label, multi-center study is to evaluate the safety and efficacy of lanadelumab in Japanese participants with HAE Type I or II.

NCT ID: NCT04057131 Completed - Clinical trials for Hereditary Angioedema (HAE)

FIRAZYR General Drug Use-Results Survey (Japan)

Start date: May 9, 2019
Phase:
Study type: Observational

The objectives of this survey are to collect data to report the safety and efficacy of Firazyr (Icatibant acetate) in the post-marketing phase in participants diagnosed with Hereditary Angioedema (HAE).

NCT ID: NCT03888755 Completed - Clinical trials for Hereditary Angioedema (HAE)

A Study of Icatibant for Acute Attacks of Hereditary Angioedema in Japanese Participants

Start date: March 18, 2015
Phase: Phase 3
Study type: Interventional

The objective of this study is to evaluate the efficacy, pharmacokinetics (PK), and safety of icatibant for the treatment of acute attacks in Japanese participants with type I or type II hereditary angioedema (HAE).

NCT ID: NCT03873116 Completed - Clinical trials for Hereditary Angioedema, HAE

Study to Evaluate the Efficacy and Safety of BCX7353 as an Oral Treatment for the Prevention of HAE Attacks in Japan

APeX-J
Start date: February 28, 2019
Phase: Phase 3
Study type: Interventional

This is a phase 3, multi-center, randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of oral BCX7353 in preventing acute angioedema attacks in patients with Type I and Type II HAE who live in Japan.

NCT ID: NCT03845400 Completed - Clinical trials for Hereditary Angioedema (HAE)

A Study of Lanadelumab in Persons With Hereditary Angioedema (HAE) Type I or II in North America

EMPOWER
Start date: March 30, 2019
Phase:
Study type: Observational

The main aim of this study is to compare the HAE attack rate before and after lanadelumab treatment was started in persons with Hereditary Angioedeme Type I or II. Data from participants will be collected for at least 24 months. Participants will report information in a smartphone application at study start and then every 3 months until the study ends; data will also be collected by the study doctor during routine clinic visits.

NCT ID: NCT03240133 Completed - Clinical trials for Hereditary Angioedema (HAE)

Study of BCX7353 as a Treatment for Attacks of Hereditary Angioedema

Start date: July 31, 2017
Phase: Phase 2
Study type: Interventional

This 3-part study will evaluate the efficacy and safety of an oral kallikrein inhibitor, BCX7353, in the treatment angioedema attacks in subjects with Type I or II hereditary angioedema (HAE). In each study part, subjects will treat 3 attacks with BCX7353 (2 attacks) or placebo (1 attack), in a randomly allocated order. In Part 1, the dose of 750mg will be assessed relative to placebo in up to 36 patients. If this is shown to be effective, then a further 12 patients will be enrolled at a 500mg dose (Part 1), followed by a further 12 (if efficacy still shown) at a dose of 250mg (Part 3) to determine the minimum effective dose of BCX7353 compared to placebo for treating HAE attacks. Efficacy will be determined by subject diary entries completed at pre-defined times post-dose.

NCT ID: NCT02870972 Completed - Clinical trials for Hereditary Angioedema (HAE)

Efficacy and Safety of BCX7353 to Prevent Angioedema Attacks in Subjects With Hereditary Angioedema

APeX-1
Start date: August 2016
Phase: Phase 2
Study type: Interventional

This 3-part study will evaluate the safety and efficacy of an oral treatment, BCX7353, in preventing angioedema attacks in subjects with hereditary angioedema (HAE). In Part 1 of the study, eligible subjects will be randomized to receive oral BCX7353 or placebo for 4 weeks. Assuming successful completion of Part 1, additional subjects will be randomized in Part 2 to one of 2 lower doses of BCX7353 or placebo. Part 3 will enroll additional subjects into one of three doses of BCX7353 or placebo. The study will compare the number of acute attacks in each treatment group, as well as a number of other clinical and pharmacologic outcomes, and the safety and tolerability of each dose of BCX7353 compared to placebo.

NCT ID: NCT02865720 Completed - Clinical trials for Hereditary Angioedema (HAE)

Study of C1 Inhibitor (Human) for the Prevention of Angioedema Attacks and Treatment of Breakthrough Attacks in Japanese Subjects With Hereditary Angioedema (HAE)

Start date: September 8, 2016
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine if an investigational treatment is safe and well tolerated when administered by intravenous (IV) infusion in Japanese subjects with HAE.