Clinical trials: Angio-Oedema and/or Urticaria
Hereditary Angioedema
Open-Label Safety, PK, and Efficacy Trial of Sebetralstat (KVD900) in Pediatric Patients (Ages 2-11) With HAE Type I or II
KVD900-303 is an open-label, multicenter clinical trial in patients aged 2 to 11 years old with HAE Type I or II.
- Trial name
- KONFIDENT-KID (NCT06467084)
- Testing
- KVD900 150 mg, KVD900 300 mg, KVD900 600 mg
- Where
- 24 sites in United States, Canada and 5 more
- Volunteers
- 36 people
- Sponsor
- KalVista Pharmaceuticals, Ltd.
Hereditary Angioedema
PK Subtrial in Adolescent Patients With HAE Type I or II Participating in the KVD900-302 Trial
This is a multicenter pharmacokinetic (PK) subtrial to investigate the PK profile of KVD900 (sebetralstat) in adolescent patients 12 to 17 years of age with Hereditary Angioedema (HAE) type I or II.
- Trial name
- NCT05511922
- Testing
- KVD900 600 mg, Drug: KVD900 300 mg
- Where
- 61 sites in United States, Australia and 15 more
- Volunteers
- 11 people
- Sponsor
- KalVista Pharmaceuticals, Ltd.
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
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.
- Trial name
- INTEGRATED (NCT04861090)
- Where
- 20 sites in Austria, France and 2 more
- Volunteers
- 207 people
- Sponsor
- Takeda
Hereditary Angioedema (HAE)
A Study of Lanadelumab in Persons With Hereditary Angioedema (HAE) Type I or II
The main aim of this study is to compare the number of HAE attacks occuring in persons using lanadelumab with the number of HAE attacks before lanadelumab treatment was started.
- Trial name
- ENABLE (NCT04130191)
- Where
- 19 sites in Austria, Germany and 5 more
- Volunteers
- 140 people
- Sponsor
- Shire
Hereditary Angioedema (HAE)
A Study About the Diagnosis and Management of Hereditary Angioedema (HAE) in Egypt
Hereditary angioedema (HAE) is a rare condition. It causes sudden swelling under the skin and inside the body, like in the belly, throat, or genitals. This swelling happens because of a temporary leak in blood vessels.
- Trial name
- EXPLORHAE (NCT07218393)
- Testing
- No intervention
- Where
- 7 sites in Egypt
- Volunteers
- 100 people
- Sponsor
- Takeda
Hereditary Angioedema
OASIS-HAE: A Study to Evaluate the Safety and Efficacy of Donidalorsen (ISIS 721744 or IONIS-PKK-LRx) in Participants With Hereditary Angioedema (HAE)
The purpose of this study was to evaluate the safety and efficacy of donidalorsen in participants with HAE and effect of donidalorsen on the quality and pattern of HAE attacks and their impact on quality of life (QoL).
- Trial name
- NCT05139810
- Testing
- Donidalorsen
- Where
- 51 sites in United States, Belgium and 12 more
- Volunteers
- 91 people
- Sponsor
- Ionis Pharmaceuticals, Inc.
Hereditary Angioedema
An Open-label Extension Trial to Evaluate the Long-term Safety of KVD900 (Sebetralstat) for On-Demand Treatment of Angioedema Attacks in Adolescent and Adult Patients With Hereditary Angioedema (HAE)
This is an open-label, multicenter extension trial to evaluate the long-term safety of KVD900 in patients who are 12 years or older with HAE type I or II.
- Trial name
- NCT05505916
- Testing
- KVD900 600 mg, KVD900 300 mg
- Where
- 71 sites in United States, Australia and 21 more
- Volunteers
- 145 people
- Sponsor
- KalVista Pharmaceuticals, Ltd.
Hereditary Angioedema (HAE)
A Study of Lanadelumab in Teenagers and Adults With Hereditary Angioedema (HAE)
The main aim of this study is to compare the HAE attacks (both total and those requiring on-demand treatment) in the 12 months before and up to 24 months after initiation of treatment with lanadelumab.
- Trial name
- NCT05469789
- Testing
- No Intervention
- Where
- United Kingdom
- Volunteers
- 50 people
- Sponsor
- Takeda
Angioedema, Hereditary, Types I and II
A Trial to Evaluate the Efficacy and Safety of Different Doses of KVD824 for Prophylactic Treatment of HAE Type I or II
A study to assess whether different doses of KVD824 are effective in preventing attacks of Hereditary Angiodedema Type I or Type II.
- Trial name
- KVD824-201 (NCT05055258)
- Testing
- KVD824
- Where
- 33 sites in United States, Australia and 11 more
- Volunteers
- 33 people
- Sponsor
- KalVista Pharmaceuticals, Ltd.
Hereditary Angioedema
A Phase II, Cross-over Clinical Trial Evaluating the Efficacy and Safety of KVD900 (Sebetralstat) in the On-demand Treatment of Angioedema Attacks in Adult Subjects With Hereditary Angioedema Type I or II
This study is a randomized, double-blind, placebo-controlled, phase II, cross-over clinical trial evaluating the efficacy and safety of KVD900, in the treatment of hereditary angioedema attacks in adult subjects.
- Trial name
- NCT04208412
- Testing
- KVD900
- Where
- 25 sites in United States, Austria and 8 more
- Volunteers
- 84 people
- Sponsor
- KalVista Pharmaceuticals, Ltd.
Hereditary Angioedema
A Phase III, Crossover Trial Evaluating the Efficacy and Safety of KVD900 (Sebetralstat) for On-Demand Treatment of Angioedema Attacks in Adolescent and Adult Patients With Hereditary Angioedema (HAE)
This study is a randomized, double-blind, placebo-controlled, phase III, three-way crossover clinical trial evaluating the efficacy and safety of KVD900, in the treatment of hereditary angioedema attacks in adolescent and adult…
- Trial name
- NCT05259917
- Testing
- KVD900 600 mg, KVD900 300 mg
- Where
- 66 sites in United States, Australia and 19 more
- Volunteers
- 136 people
- Sponsor
- KalVista Pharmaceuticals, Ltd.
Hereditary Angioedema (HAE)
A European Post-Authorisation Observational Study Of Patients With Hereditary Angioedema
This observational (non-interventional) study is being conducted to characterize the safety and use of CINRYZE in routine clinical practice when administered for (1) routine prevention of angioedema attacks, (2) pre-procedure…
- Trial name
- NCT01541423
- Where
- 20 sites in Belgium, France and 4 more
- Volunteers
- 83 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
Angioedema
C1-Esteraseremmer-N for the Treatment of Hereditary (and Acquired) Angioedema
A multicentre study to investigate the pharmacokinetics, clinical efficacy and safety of nanofiltered Cetor® (called C1-esteraseremmer-N during the development phase) for the treatment of hereditary angioedema (HAE) will be…
- Trial name
- NCT00125151
- Testing
- C1 inhibitor concentrate (C1-esteraseremmer-N)
- Where
- 3 sites in Netherlands
- Volunteers
- 15 people
- Sponsor
- Prothya Biosolutions
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
Treatment of Angioedema Attacks in Adolescent and Adult Patients 12 Years and Older With HAE Type I or II With Sebetralstat
The sebetralstat Early Access Program (EAP) provides early access to the investigational medicinal product (IMP) sebetralstat to eligible and approved Type I or II Hereditary Angioedema (HAE) adolescent and adult post-trial and…
- Trial name
- NCT06628713
- Testing
- Sebetralstat
- Where
- United States
- Sponsor
- KalVista Pharmaceuticals, Ltd.
Hereditary Angioedema
HAELO: A Phase 3 Study to Evaluate NTLA-2002 in Participants With Hereditary Angioedema (HAE)
This Phase 3 study aims to evaluate the efficacy and safety of NTLA-2002 compared to placebo in participants with HAE.
- Trial name
- NCT06634420
- Testing
- NTLA-2002, Normal Saline IV Administration
- Where
- 29 sites in United States, Australia and 7 more
- Volunteers
- 80 people
- Sponsor
- Intellia Therapeutics
Angioedema
C1-Esteraseremmer-N for the Treatment of Hereditary (and Acquired) Angioedema
A multicentre study to investigate the pharmacokinetics, clinical efficacy and safety of nanofiltered Cetor® (called C1-esteraseremmer-N during the development phase) for the treatment of hereditary angioedema (HAE) will be…
- Trial name
- NCT00125541
- Testing
- C1 inhibitor concentrate (C1-esteraseremmer-N)
- Where
- Netherlands
- Volunteers
- 6 people
- Sponsor
- Prothya Biosolutions
Hereditary Angioedema, Hereditary Angioedema Type I
Dose-ranging Study of Oral PHA-022121 for Prophylaxis Against Angioedema Attacks in Patients With Hereditary Angioedema Type I or Type II
This study evaluates the safety and efficacy of PHA-022121 administered orally for prophylaxis against angioedema attacks in patients with hereditary angioedema (HAE).
- Conditions
- Hereditary Angioedema, Hereditary Angioedema Type I, Hereditary Angioedema Type II, Hereditary Angioedema Types I and II
- Trial name
- HAE CHAPTER-1 (NCT05047185)
- Testing
- Deucrictibant low dose, Deucrictibant high dose
- Where
- 19 sites in United States, Austria and 7 more
- Volunteers
- 34 people
- Sponsor
- Pharvaris Netherlands B.V.
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