Clinical trials: Angioedema
Hereditary Angioedema (HAE)
Open-label, Single-arm Study to Assess the Pharmacokinetics, Safety, and Tolerability of a Single Subcutaneous Dose of Icatibant in Healthy Japanese Volunteers
This is a single-dose study to evaluate the pharmacokinetics, safety, and tolerability of icatibant administered to adult Japanese subjects.
- Trial name
- NCT02045264
- Testing
- Icatibant (30 mg)
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Shire
Hereditary Angioedema
A Single Dose Safety, Tolerability, Pharmacokinetic and Food Effect Study of KVD900 (Sebetralstat) in Healthy Volunteers
A safety, tolerability, pharmacokinetic and food effect study of KVD900 in healthy volunteers.
- Trial name
- NCT04349800
- Testing
- KVD900
- Where
- United Kingdom
- Volunteers
- 84 people, healthy volunteers welcome
- Sponsor
- KalVista Pharmaceuticals, Ltd.
Hereditary Angioedema (HAE)
CSL312_3003 Safety and Pharmacokinetic Study in Subjects 2 to 11 Years of Age With Hereditary Angioedema
The purpose of this study is to investigate the safety, PK / PD, and efficacy of SC CSL312 for prophylactic treatment of pediatric subjects with HAE.
- Trial name
- NCT05819775
- Testing
- CSL312
- Where
- 13 sites in United States, Australia and 3 more
- Volunteers
- 22 people
- Sponsor
- CSL Behring
Endotoxemia, Inflammation
In Vivo Effects of C1-esterase Inhibitor on the Innate Immune Response During Human Endotoxemia
Excessive inflammation is associated with tissue damage caused by over-activation of the innate immune system. This can range from mild disease to extreme conditions such as multiple organ failure (MOF).
- Conditions
- Endotoxemia, Inflammation, Multi Organ Dysfunction Syndrome
- Trial name
- VECTOR (NCT00785018)
- Testing
- C1-esterase inhibitor, Endotoxin administration
- Where
- Netherlands
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Radboud University Medical Center
Hereditary Angioedema
A Study to Assess the Clinical Efficacy of Donidalorsen (Also Known as IONIS-PKK-LRx and ISIS 721744) in Participants With Hereditary Angioedema
The purpose of this study was to evaluate the clinical efficacy, safety, and tolerability of donidalorsen in participants with hereditary angioedema (HAE) type 1 (HAE-1), HAE type 2 (HAE-2), or HAE with normal C1-inhibitor…
- Trial name
- NCT04030598
- Testing
- Donidalorsen
- Where
- 8 sites in United States, Netherlands
- Volunteers
- 23 people
- Sponsor
- Ionis Pharmaceuticals, Inc.
Hereditary Angioedema Types I and II
Postmarketing Immunogenicity Study in HAE Subjects Treated With Berinert
This is a prospective, international, multi-center, non-randomized, single arm, open-label, postmarketing study to investigate the formation of inhibitory anti-C1-INH antibodies in HAE subjects treated intravenously with…
- Trial name
- NCT01467947
- Testing
- Berinert, lyophilizate for IV application containing 500 IU C1-INH to be reconstituted with 10 mL water for injection
- Where
- 4 sites in Bulgaria, Hungary and 2 more
- Volunteers
- 46 people
- Sponsor
- CSL Behring
Bradykinin-mediated Angioedema, Hereditary Angioedema (HAE)
A Study to Evaluate the Safety and Efficacy of Icatibant in Patients With Bradykinin Induced Angioedema
This is a phase IV clinical study. The investigators collect patients with a diagnosis of bradykinin induced angioedema. For a specific study period and prospectively arrange, the eligible patients who has an acute attack of…
- Trial name
- NCT07290855
- Testing
- Icatibant Injection (Icanticure®)
- Where
- Taiwan
- Volunteers
- 5 people
- Sponsor
- Nang Kuang Pharmaceutical Co., Ltd.
Hereditary Angioedema
Treatment of Hereditary Angioedema Prodrome with Recombinant C1-esterase Inhibitor (Ruconest)
To assess the efficacy of recombinant human C1-esterase inhibitor in the management of HAE prodrome for preventing the progression from prodrome to an acute angioedema attacks.
- Trial name
- NCT06690047
- Testing
- Ruconest
- Where
- 2 sites in United States
- Volunteers
- 5 people
- Sponsor
- Bernstein Clinical Research Center
Hereditary Angioedema (HAE)
A Study of Navenibart in Participants With Hereditary Angioedema
This is a Phase 3 multicenter, randomized, double-blind, placebo-controlled clinical trial evaluating the safety and efficacy of subcutaneous administration of navenibart in adult and adolescent participants with type 1 or type 2…
- Trial name
- ALPHA-ORBIT (NCT06842823)
- Testing
- navenibart
- Where
- 86 sites in United States, Australia and 22 more
- Volunteers
- 157 people
- Sponsor
- Astria Therapeutics, Inc.
Hereditary Angioedema
Safety of Ruconest in 2-13 Year Old Hereditary Angioedema (HAE) Patients
This open-label study is being conducted to confirm the safety, pharmacokinetic profile and efficacy of Ruconest at a dose of 50 U/kg when used for the treatment of acute angioedema attacks in patients, from 2 up to and including…
- Trial name
- NCT01359969
- Testing
- rhC1INH
- Where
- 16 sites in United States, Czechia and 8 more
- Volunteers
- 57 people
- Sponsor
- Pharming Technologies B.V.
Hereditary Angioedema (HAE)
Firazyr® Patient Registry (Icatibant Outcome Survey - IOS)
The Icatibant Outcome Survey (IOS) is a prospective, observational disease registry designed to document the routine clinical outcomes over time in participants with angioedema treated with Firazyr® (icatibant) and/or Cinryze®…
- Trial name
- NCT01034969
- Where
- 74 sites in Australia, Austria and 12 more
- Volunteers
- 1,761 people
- Sponsor
- Shire
Angioedema
A Study of Long-Term Safety and Efficacy of Lanadelumab for Prevention of Acute Attacks of Non-histaminergic Angioedema With Normal C1-Inhibitor
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…
- Trial name
- NCT04444895
- Testing
- Lanadelumab
- Where
- 35 sites in United States, Canada and 8 more
- Volunteers
- 73 people
- Sponsor
- Shire
Urticaria, Angioedema
The Efficacy of a Pseudoallergen-Free Diet in the Treatment of Chronic Idiopathic Urticaria and/or Angioedema
This study involves investigating the effects of a pseudoallergen-free (active) diet compared with a control (placebo) diet in the treatment of Chronic Idiopathic Urticaria (CIU) and/or Angioedema.
- Trial name
- NCT00163839
- Testing
- Dietary Therapy
- Where
- Australia
- Volunteers
- 50 people
- Sponsor
- Bayside Health
Hereditary Angioedema Types I and II
A Study to Evaluate the Clinical Efficacy and Safety of Subcutaneously Administered C1-esterase Inhibitor in the Prevention of Hereditary Angioedema
The aim of this study is to assess the efficacy of C1-esterase inhibitor in preventing hereditary angioedema attacks when it is administered under the skin of subjects with hereditary angioedema.
- Trial name
- NCT01912456
- Testing
- Low-volume C1-esterase inhibitor, Higher-volume C1-esterase inhibitor
- Where
- 39 sites in United States, Australia and 8 more
- Volunteers
- 90 people
- Sponsor
- CSL Behring
Hereditary Angioedema (HAE)
Study to Evaluate Ecallantide in Paediatric Patients With Acute Attacks of Hereditary Angioedema
The primary objective of this study is: assess the safety and tolerability of ecallantide in paediatric patients for acute attacks of HAE The secondary objectives are: evaluate the pharmacokinetic profile of ecallantide in…
- Trial name
- NCT01253382
- Testing
- ecallantide
- Sponsor
- Shire
Hereditary Angioedema
A Study of Icatibant (TAK-667) in Japanese Children and Teenagers With Acute Attacks of Hereditary Angioedema
The main aim of the study is to check for side effects from icatibant in children and teenagers with hereditary angioedema (HAE).
- Trial name
- NCT04654351
- Testing
- TAK-667
- Where
- 3 sites in Japan
- Volunteers
- 2 people
- Sponsor
- Takeda
Hereditary Angioedema, HAE
Oral Berotralstat Expanded Access Program
This expanded access program will provide access to berotralstat for eligible participants with hereditary angioedema in the U.S.
- Conditions
- Hereditary Angioedema, HAE, Prophylaxis
- Trial name
- NCT04428632
- Testing
- Berotralstat
- Sponsor
- BioCryst Pharmaceuticals
Hereditary Angioedema (HAE), Angioedema
Oral Deucrictibant for Prophylactic and Acute Treatment in Hereditary Angioedema Patients
To assess the efficacy of prophylactic treatment with deucrictibant extended release (XR) tablet versus placebo in preventing angioedema attacks, and to also assess the efficacy of deucrictibant soft capsules as on-demand…
- Conditions
- Hereditary Angioedema (HAE), Angioedema, Bradykinin-mediated Angioedema, C1 Inhibitor Deficiency
- Trial name
- BK-AE-nC1INH (NCT07046806)
- Testing
- Deucrictibant XR tablet, Deucrictibant 20 mg capsule
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Institute for Asthma and Allergy
Hereditary Angioedema
Expanded Access Program With Lanadelumab for Japanese People With Hereditary Angioedema
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.
- Trial name
- NCT04687137
- Testing
- TAK-743 300 mg
- Where
- 9 sites in Japan
- Volunteers
- 12 people
- Sponsor
- Takeda
Ebola Virus Disease, Marburg Virus Disease
Evaluation of Safety, Tolerability and Immune Responses of Ebola-S and Marburg Vaccines in Healthy Adults
Primary Objective: To evaluate the safety and tolerability of cAd3-EBO-S and cAd3 Marburg vaccines when administered Intramuscular (IM) at a dose of 1 x 10^11 particle units (PU) to healthy adults.
- Trial name
- NCT04723602
- Testing
- cAd3-Marburg, cAd3-EBO-S
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Albert B. Sabin Vaccine Institute