Clinical trials: HAE
Hereditary Angioedema (HAE)
A Survey of Icatibant in Pediatric Participants With Hereditary Angioedema
This study is a survey in Japan of Icatibant subcutaneous injection 30 mg syringe used to treat children or teenagers with acute attacks of hereditary angioedema (HAE).
- Trial name
- NCT05509569
- Testing
- Icatibant
- Where
- Japan
- Volunteers
- 32 people
- Sponsor
- Takeda
Hereditary Angioedema
A Study Observing US Patients With HAE Type I or II Who Take Icatibant to Treat HAE Attacks
Patients with HAE Type I or II who enroll in the study are asked to complete a patient diary when they experience an HAE attack.
- Trial name
- ICTOS (NCT07009262)
- Testing
- Inapplicable
- Where
- United States
- Volunteers
- 88 people
- Sponsor
- KalVista Pharmaceuticals, Ltd.
Hereditary Angioedema
Open-Label C1 Esterase Inhibitor (C1INH-nf) for the Prevention of Acute Hereditary Angioedema (HAE) Attacks
The study objective was to evaluate the safety and efficacy of prophylactic use of C1INH-nf for the prevention of acute HAE attacks.
- Trial name
- CHANGE 3 (NCT00462709)
- Testing
- C1 esterase inhibitor [human] (C1INH-nf)
- Where
- 48 sites in United States
- Volunteers
- 146 people
- Sponsor
- Shire
Hereditary Angioedema (HAE)
HAE Burden and Crisis Management
The study has been designed as a French, multicentric survey study to obtain data to describe the burden of on-demand treatment for patients with hereditary angioedema (HAE).
- Trial name
- ECRINS (NCT06806618)
- Where
- France
- Volunteers
- 300 people
- Sponsor
- University Hospital, Grenoble
Hereditary Angioedema, Pediatric
Berotralstat Treatment in Children With Hereditary Angioedema
The purpose of this study is to evaluate the pharmacokinetics (PK), safety and effectiveness of berotralstat to determine the appropriate weight-based dose for pediatric participants 2 to < 12 years of age for prophylactic…
- Trial name
- APeX-P (NCT05453968)
- Testing
- Berotralstat
- Where
- 15 sites in Austria, Canada and 8 more
- Volunteers
- 29 people
- Sponsor
- BioCryst Pharmaceuticals
ANGIOEDEMA
CLOUD-R HAE REGISTRY
Angioedema is a disease characterized by the appearance of self-limiting edema that last 1-5 days and affect the subcutaneous tissue and/or gastrointestinal and oropharyngeal mucosa.
- Trial name
- CloudRHAE (NCT03845946)
- Testing
- angioedema
- Where
- France
- Volunteers
- 1,000 people
- Sponsor
- University Hospital, Grenoble
Hereditary Angioedema (HAE)
Long-Term, Open-label Study of Oral Deucrictibant Extended-Release Tablet for Prophylaxis Against Angioedema Attacks in Adolescents and Adults With HAE
This is a Phase 3, multicenter, long-term, open-label study to evaluate the safety and efficacy of once-daily orally administered deucrictibant extended-release tablet for prophylaxis to prevent angioedema attacks in participants…
- Trial name
- CHAPTER-4 (NCT06679881)
- Testing
- Deucrictibant
- Where
- 67 sites in United States, Argentina and 21 more
- Volunteers
- 170 people
- Sponsor
- Pharvaris Netherlands B.V.
Includes: Hereditary Angioedema
Patient Registry Study of Berinert® in Normal Clinical Practice
The objective of this patient registry is to collect data on the safety of Berinert® in normal clinical practice in the United States. The patient registry will be maintained for a period of at least 3 years.
- Trial name
- NCT01108848
- Testing
- Berinert® (C1 Esterase Inhibitor)
- Where
- 40 sites in United States, Denmark and 2 more
- Volunteers
- 318 people
- Sponsor
- CSL Behring
Hereditary Angioedema (HAE)
A Long-Term Study of Navenibart in Participants With Hereditary Angioedema
This is a Phase 3 multicenter trial in 2 parts to evaluate the long-term safety and efficacy of navenibart in adult and adolescent participants with hereditary angioedema (HAE) who participated in STAR-0215-301 (NCT06842823…
- Trial name
- NCT07204938
- Testing
- navenibart
- Where
- 40 sites in United States, Brazil and 16 more
- Volunteers
- 145 people
- Sponsor
- Astria Therapeutics, Inc.
Angioedemas, Hereditary
A Study of Lanadelumab in Teenagers and Adults With Hereditary Angioedema (HAE) in Argentina
The main aim of this study is to learn about the safety profile of lanadelumab in teenagers and adults with hereditary angioedema (HAE) in Argentina as part of routine routine practice. This study is about collecting data only.
- Trial name
- NCT04955964
- Where
- Argentina
- Volunteers
- 48 people
- Sponsor
- Takeda
Hereditary Angioedema (HAE)
A Study of Lanadelumab in Persons With Hereditary Angioedema (HAE) Type I or II in North America
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.
- Trial name
- EMPOWER (NCT03845400)
- Where
- 29 sites in United States, Canada and 1 more
- Volunteers
- 168 people
- Sponsor
- Shire
Hereditary Angioedema
Human C1 Esterase Inhibitor (C1-INH) in Subjects With Acute Abdominal or Facial Hereditary Angioedema (HAE) Attacks
HAE is a rare disorder characterized by functional C1 esterase inhibitor deficiency. If not treated adequately, the acute attacks of HAE can be life-threatening and may even result in fatalities, especially in case of swelling of…
- Trial name
- NCT00168103
- Testing
- C1 Esterase Inhibitor
- Where
- 36 sites in United States, Argentina and 13 more
- Volunteers
- 126 people
- Sponsor
- CSL Behring
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
Hereditary Angioedema
Assessment of the State of Health, Quality of Life and Expectations of Patients With Hereditary Angioedema
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…
- Trial name
- BESQAOH (NCT04888650)
- Testing
- questionnaire
- Where
- France
- Volunteers
- 314 people
- Sponsor
- University Hospital, Grenoble
Hereditary Angioedema, Angioneurotic Edema
Recombinant Human C1 Inhibitor for the Treatment of Acute Attacks in Patients With Hereditary Angioedema
Hereditary angioedema ("HAE") is a genetic disorder characterized by sudden recurrent attacks of local swelling (angioedema). These attacks are often painful and disabling, and, in some cases, life-threatening.
- Trial name
- NCT00225147
- Testing
- Recombinant Human C1 Inhibitor
- Where
- Netherlands
- Volunteers
- 77 people
- Sponsor
- Pharming Technologies B.V.
Hereditary Angioedema
Treatment of Angioedema Attacks in Pediatric (Ages 2-11) Post-Trial and Naive Patients With HAE With Sebetralstat
The sebetralstat Early Access Program (EAP) provides early access to the investigational medicinal product (IMP) sebetralstat to eligible and approved Hereditary Angioedema (HAE) pediatric (ages 2-11) post-trial and naïve…
- Trial name
- NCT07216378
- Testing
- Sebetralstat
- Where
- 6 sites in United States
- Sponsor
- KalVista Pharmaceuticals, Ltd.
Hereditary Angioedema (HAE)
A Study of Lanadelumab (Takhzyro) and Icatibant (Firazyr®) in Persons With HAE in China
The Chinese health authority has approved lanadelumab to prevent Hereditary Angioedema (HAE) attacks in persons of 12 years and older. It has also approved icatibant to treat acute HAE attacks in persons 2 years and older.
- Trial name
- NCT06346899
- Testing
- No intervention
- Where
- 13 sites in China
- Volunteers
- 115 people
- Sponsor
- Takeda
Hereditary Angioedema
Efficacy, Safety and Immunogenicity Study of Recombinant Human C1 Inhibitor for the Treatment of Acute HAE Attacks
This study is being conducted to confirm the efficacy, safety, and immunogenicity of recombinant human C1 inhibitor (rhC1INH) at a dose of 50 U/kg when used for the treatment of acute angioedema attacks in Hereditary Angioedema…
- Trial name
- NCT01188564
- Testing
- rhC1INH
- Where
- 27 sites in United States, Bulgaria and 9 more
- Volunteers
- 75 people
- Sponsor
- Pharming Technologies B.V.
Hereditary Angioedema
Safety and Pharmacokinetics of GNR-038 in Healthy Volunteers
It is an open-label dose-escalating study in sequential cohorts to assess safety and pharmacokinetics of GNR-038.
- Trial name
- NCT04557319
- Testing
- GNR-038, 25 МЕ/kg, GNR-038, 50 МЕ/kg, GNR-038, 100 МЕ/kg
- Where
- Russia
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- AO GENERIUM
Hereditary Angioedema
A Study of Lanadelumab to Prevent Hereditary Angioedema (HAE) Attacks in Children
The main aims of this study are to learn how lanadelumab moves through a child's body and if the children have any medical problems from lanadelumab.
- Trial name
- SPRING (NCT04070326)
- Testing
- Lanadelumab
- Where
- 17 sites in United States, Canada and 3 more
- Volunteers
- 21 people
- Sponsor
- Shire