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HAE clinical trials

View clinical trials related to HAE.

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NCT ID: NCT05121376 Active, not 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: NCT04933721 Active, not recruiting - Clinical trials for Hereditary Angioedema

Open-label Berotralstat Access to HAE Patients Previously Enrolled in Berotralstat Studies

APeX-A
Start date: July 23, 2021
Phase: Phase 3
Study type: Interventional

This is a phase 3b open-label study providing access to berotralstat for HAE patients who were previously enrolled in berotralstat studies.

NCT ID: NCT04428632 Approved for marketing - Clinical trials for Hereditary Angioedema

Oral Berotralstat Expanded Access Program

Start date: n/a
Phase:
Study type: Expanded Access

This expanded access program will provide access to berotralstat for eligible participants with hereditary angioedema in the U.S.

NCT ID: NCT03485911 Completed - Clinical trials for Hereditary Angioedema

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

APeX-2
Start date: February 6, 2018
Phase: Phase 3
Study type: Interventional

This is a phase 3, multicenter, 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.

NCT ID: NCT03472040 Completed - Clinical trials for Hereditary Angioedema

A Long Term Safety Study of BCX7353 in Hereditary Angioedema

APeX-S
Start date: February 16, 2018
Phase: Phase 2/Phase 3
Study type: Interventional

This is an open-label study to evaluate the long term safety and effectiveness of oral treatment with BCX7353 in preventing acute angioedema attacks in patients with Type I and Type II Hereditary Angioedema (HAE).

NCT ID: NCT03029728 Completed - Clinical trials for Hereditary Angioedema

Biomarker for Hereditary AngioEdema Disease

BioHAE
Start date: August 20, 2018
Phase:
Study type: Observational

International, multicenter, observational, longitudinal monitoring study to identify, validate and/or monitor Mass Spectrometry (MS)-based biomarker/s for Hereditary Angioedeme (HAE) disease and to test the clinical robustness, specificity, and predictive value of theese biomarker/s

NCT ID: NCT02670720 Terminated - Clinical trials for Hereditary Angioedema

Open-label, Long-term Safety Study of Avoralstat in Subjects With Hereditary Angioedema

OPuS-4
Start date: December 2015
Phase: Phase 3
Study type: Interventional

This is an open-label study designed to evaluate the long-term safety of prophylactic avoralstat (500 mg three times daily) when given to approximately 150 patients with hereditary angioedema (HAE) for a duration of up to 72 weeks. The study will also evaluate the long-term efficacy and impact on quality of life of avoralstat prophylactic treatment.

NCT ID: NCT02303626 Completed - Clinical trials for Hereditary Angioedema

12-Week Safety and Efficacy Study of BCX4161 as an Oral Prophylaxis Against HAE Attacks

OPuS-2
Start date: November 2014
Phase: Phase 2/Phase 3
Study type: Interventional

This study will evaluate the safety and efficacy of an oral treatment, BCX4161, in preventing acute attacks in subjects with hereditary angioedema (HAE). Eligible subjects will be randomized to receive one of two doses of BCX4161 or placebo for 12 weeks. The study will compare the number of acute attacks in each treatment group, as well as a number of other clinical outcomes, and the safety and tolerability of each dose of BCX4161 compared to placebo.