Clinical Trials

According to clinicaltrials.gov under the U.S. National Institutes of Health, the EU Clinical Trials Register, and the International Clinical Trials Registry Platform under World Health Organization (WHO) the following trials should be recruiting at this moment (updated March 2021):

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 HAE

– recruiting in Canada, Germany, Hungary, Israel, Italy, the Netherlands, Spain, and the United States of America

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A multicenter, randomized, placebo-controlled, parallel-arm study to investigate the efficacy, pharmacokinetics, and safety of CSL312 in subjects with HAE

– recruiting in Australia, Canada, Denmark, Germany, Israel, and the United States of America

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An Open-Label study to Evaluate the Long-Term Safety of Daily Oral BCX7353 in subjects with Type I and II HAE

– recruiting in Australia, the European Union, Hong Kong, Israel, New Zealand, North Macedonia, Serbia, South Africa, South Korea, Switzerland, and the United States of America

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An Open-Label Extension Study of ISIS 721744 in Patients with HAE

– recruiting in the Netherlands, the United Kingdom, and the United States of America

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A Phase II, double-blind, placebo-controlled, Randomized, cross-over, dose-ranging study of oral PHA-022121 for Acute treatment of angioedema attacks in Patients with HAE due to C1-Inhibitor Deficiency type I and II

– recruiting in Belgium, Canada, France, Germany, Hungary, Israel, Italy, the Netherlands, Poland, Spain, and the United Kingdom

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A randomized, double-blind, placebo-controlled, phase II, cross-over clinical trial evaluating the efficacy and safety of KVD900, an oral plasma kallikrein inhibitor, in the on-demand treatment of angioedema attacks in adult subjects with HAE type IorII

– recruiting in North Macedonia and the United States of America

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A Randomized, Double Blind, Placebo Controlled, Phase 2a Study to Assess the Clinical Efficacy of ISIS 721744, a Second Generation Ligand Conjugated Antisense Inhibitor of Prekallikrein, in Patients with HAE

– recruiting in the Netherlands, the United Kingdom, and the United States of America

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A Study of Icatibant (TAK-667) in Japanese Children and Teenagers with Acute Attacks of HAE

– recruiting in Japan

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Biomarker for HAE Disease

– recruiting in Armenia, Georgia, Peru, Poland, Romania, and Turkey

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C1 Inhibitor Registry in the Treatment of HAE Attacks

– recruiting in Bulgaria, Croatia, Czech Republic, France, Germany, Hungary, Italy, North Macedonia, Norway, Poland, Slovakia, Slovenia, and Sweden

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CSL312 (Garadacimab) in the Prevention of HAE Attacks

– recruiting in Canada and the United States of America

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Dose-ranging Study of Oral PHA-022121 for Acute Treatment of Angioedema Attacks in Patients with HAE

– recruiting in Canada

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Efficacy and Safety of Lanadelumab (SHP643) in Japanese Participants with HAE

– recruiting in Japan

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Efficacy and Safety of Lanadelumab for Prevention Against Acute Attacks of Non-histaminergic Angioedema with Normal C1-Inhibitor (C1-INH)

– recruiting in the United States of America

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Epidemiological Analysis for HAE Disease

– recruiting in Germany, Italy, Japan, Poland, Turkey, and the United Kingdom

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Firazyr General Drug Use-Results Survey (Japan)

– recruiting in Japan

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Firazyr Patient Registry (Icatibant Outcome Survey – IOS)

– recruiting in Australia, Austria, Brazil, Czech Republic, Denmark, France, Germany, Greece, Ireland, Israel, Italy, Spain, Sweden, and the United Kingdom

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Global Registry to Gather Data on Natural History of Patients with HAE Type I and II

– recruiting in Italy

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HAE Kininogen Assay

– recruiting in Germany

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Involvement of Monocytic B1 and B2 Receptors in Inflammation and Chronic Vascular Disease in Patients with Hereditary Bradykinetic Angioedema

– recruiting in France

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Patient Registry to Evaluate the Real-world Safety of Ruconest

– recruiting in the United States of America

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Pharmacokinetics and Safety of Human Pasteurized C1-Inhibitor Concentrate (Berinert/CE1145) in Subjects with Congenital C1-INH Deficiency and Frequent HAE Attacks

– recruiting in Italy

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Prospective, open-label, single arm, multicenter, pharmacokinetic, and safety study of a single dose intravenous human plasma-derived C1 Esterase Inhibitor (C1-INH) concentrate in patients with congenital C1-INH deficiency and HAE

– recruiting in Belarus, Bulgaria, Czech Republic, Germany, Hungary, Poland, the Russian Federation, Serbia, and Ukraine

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Spring Study: An Open-Label, Multicenter, Phase 3 Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Lanadelumab for Prevention Against Acute Attacks of HAE in Pediatric Subjects 2 to <12 Years of Age

– recruiting in Canada, Germany, Hungary, Spain, and the United States of Americ

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Study to Evaluate the Real-world Effectiveness of Lanadelumab in Participants with HAE

– recruiting in Canada, Puerto Rico, and the United States of America

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Study to Evaluate the Real-World Long-Term Effectiveness of Lanadelumab in Participants with HAE

– recruiting in Austria, Germany, Israel, Switzerland, and the United Kingdom

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The Role of the Coagulation Pathways in Recurrent Angioedema

– recruiting in France

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

– will be recruiting in the United States of America

Japan Expanded Access Program with Lanadelumab for Japanese Patients with HAE

– will be recruiting in Japan

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Long-term Safety and Efficacy of CSL312 (Garadacimab) in the Prophylactic Treatment of HAE Attacks

– will be recruiting (countries will be disclosed later)

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Read more about these and other clinical trials at

www.clinicaltrials.gov
www.clinicaltrialsregister.eu
www.apps.who.int/trialsearch