Clinical trials: ANGIOEDEMA
Hereditary Angioedema (HAE)
Long-term Safety and Efficacy Study of DX-2930 (SHP643) to Prevent Acute Angioedema Attacks in Patients With Type I and Type II HAE
This study is an open-label, long term safety and efficacy study to evaluate DX-2930 in preventing acute angioedema attacks in participants with Type I and Type II HAE.
- Trial name
- NCT02741596
- Testing
- DX-2930
- Where
- 43 sites in United States, Canada and 5 more
- Volunteers
- 212 people
- Sponsor
- Shire
Hereditary Angioedema (HAE)
Efficacy and Safety Study of DX-2930 to Prevent Acute Angioedema Attacks in Patients With Type I and Type II HAE
This is a phase 3, multicenter, randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of DX-2930 in preventing acute angioedema attacks in patients with Type I and Type II HAE.
- Trial name
- NCT02586805
- Testing
- DX-2930 - 300mg/2wk, DX-2930 - 300mg/4wk, DX-2930 - 150mg/4wk
- Where
- 41 sites in United States, Canada and 5 more
- Volunteers
- 125 people
- Sponsor
- Shire
Hereditary Angioedema (HAE)
Safety and Efficacy Study of CINRYZE for Prevention of Angioedema Attacks in Children Ages 6-11 With Hereditary Angioedema
Primary Objective - To assess the relative efficacy of two dose levels of CINRYZE (500 Units and 1000 Units) administered by intravenous (IV) injection every 3 or 4 days to prevent angioedema attacks in children 6 to 11 years of…
- Trial name
- NCT02052141
- Testing
- CINRYZE 500, CINRYZE 1000
- Where
- 8 sites in United States, Germany and 3 more
- Volunteers
- 12 people
- Sponsor
- Shire
Hereditary Angioedema Types I and II
A Study to Evaluate the Long-term Clinical Safety and Efficacy of Subcutaneously Administered C1-esterase Inhibitor in the Prevention of Hereditary Angioedema
The aim of this study is to assess the long-term safety of C1-esterase inhibitor (C1-INH) in preventing hereditary angioedema (HAE) attacks when it is administered under the skin of subjects with HAE.
- Trial name
- NCT02316353
- Testing
- C1-esterase inhibitor
- Where
- 32 sites in United States, Australia and 9 more
- Volunteers
- 126 people
- Sponsor
- CSL Behring
Hereditary Angioedema
A Phase 2 HAE Prophylaxis Study With Recombinant Human C1 Inhibitor
Primary Objective: To evaluate the efficacy of recombinant human C1 inhibitor (rhC1INH) in the prophylaxis of angioedema attacks in patients with HAE Secondary Objective: To evaluate the safety and immunogenicity of recombinant…
- Trial name
- NCT02247739
- Testing
- Recombinant human C1 inhibitor
- Where
- 10 sites in United States, Canada and 5 more
- Volunteers
- 32 people
- Sponsor
- Pharming Technologies B.V.
Hereditary Angioedema
A Study to Investigate CSL312 in Subjects With Hereditary Angioedema (HAE)
This is a multicenter, randomized, placebo-controlled, parallel-arm, phase 2 study to investigate the clinical efficacy, pharmacokinetics, and safety of CSL312 as prophylaxis to prevent attacks in subjects with HAE.
- Trial name
- NCT03712228
- Testing
- Factor XIIa antagonist monoclonal antibody
- Where
- 16 sites in United States, Australia and 3 more
- Volunteers
- 44 people
- Sponsor
- CSL Behring
Idiopathic Angioedema
Treatment of Idiopathic Angioedema With Xolair as Add-on Therapy
The overall hospitalizations for a diagnosis of angioedema doubled from the year 2000 to 2009. Although some of the cases represented hereditary angioedema or ace-inhibitor induced angioedema, the majority of episodes were…
- Trial name
- NCT02966314
- Testing
- Omalizumab
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- University of Wisconsin, Madison
Chronic Spontaneous Urticaria
A Phase 3 Study of Efficacy and Safety of Remibrutinib in the Treatment of CSU in Adults Inadequately Controlled by H1-antihistamines
The purpose of this study was to establish the efficacy, safety, and tolerability of Remibrutinib 25 mg b.i.d. in adult patients suffering from chronic spontaneous urticaria (CSU) inadequately controlled by second generation…
- Trial name
- REMIX-2 (NCT05032157)
- Testing
- LOU064 (blinded), LOU064 (open-label)
- Where
- 122 sites in United States, Austria and 16 more
- Volunteers
- 455 people
- Sponsor
- Novartis Pharmaceuticals
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.
- Conditions
- Hereditary Angioedema, Angioneurotic Edema, Genetic Disorders
- Trial name
- NCT00262301
- Testing
- recombinant human C1 inhibitor
- Where
- 2 sites in Netherlands, Romania
- Volunteers
- 75 people
- Sponsor
- Pharming Technologies B.V.
ACE Inhibitor Induced Angioedema
Evaluation of Ecallantide for Treatment of Angiotensin Converting Enzyme (ACE) Inhibitor Induced Angioedema
A double-blind, randomized, controlled trial comparing the safety and effectiveness of conventional therapy with ecallantide to conventional therapy with placebo.
- Trial name
- NCT01343823
- Testing
- ecallantide 60 mg, ecallantide 30 mg, ecallantide 10 mg
- Where
- 39 sites in United States
- Volunteers
- 79 people
- Sponsor
- Shire
Hereditary Angioedema
A Study to Evaluate the Safety and Effect of Escalating Doses of CINRYZE
The objectives of the study were: 1. To assess the safety and tolerability of escalating doses of CINRYZE. 2. To assess the effect of an escalating dose algorithm for CINRYZE on hereditary angioedema (HAE) attack rates. 3.
- Trial name
- NCT00914966
- Testing
- C1 inhibitor (human) [C1 INH]
- Where
- 11 sites in United States
- Volunteers
- 20 people
- Sponsor
- Shire
Chronic Spontaneous Urticaria, Angioedema
Impact of Omalizumab on Quality of Life Measures and Angioedema Occurrence in Patients With CSU Refractory to Therapy
This study will assess the impact of omalizumab on the quality of life improvement when added to the standard therapy in refractory patients suffering from chronic spontaneous urticaria and angioedema.
- Trial name
- X-ACT (NCT01723072)
- Testing
- Omalizumab
- Where
- 25 sites in Germany
- Volunteers
- 91 people
- Sponsor
- Novartis Pharmaceuticals
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 (HAE)
Subcutaneous CINRYZE With Recombinant Human Hyaluronidase for Prevention of Angioedema Attacks
The primary objectives of the study are to evaluate the safety, tolerability, and efficacy of two doses of CINRYZE with recombinant human hyaluronidase (rHuPH20) administered by subcutaneous (SC) injection to prevent angioedema…
- Trial name
- NCT01756157
- Testing
- CINRYZE with rHuPH20
- Where
- 23 sites in United States, Germany and 2 more
- Volunteers
- 47 people
- Sponsor
- Shire
Hereditary Angioedema (HAE)
Efficacy and Safety Study of DX-88 to Treat Acute Attacks of Hereditary Angioedema (HAE)
The purpose of this study is to determine if a subcutaneous dose of DX-88 (ecallantide; an investigational product) is safe and relieves symptoms of HAE in patients suffering from moderate to severe acute attacks of HAE.
- Trial name
- NCT00262080
- Testing
- ecallantide, Phosphate Buffer Saline (PBS),
- Where
- United States
- Volunteers
- 91 people
- Sponsor
- Shire
Hereditary Angioedema (HAE)
Safety and Efficacy Study of Repeated Doses of DX-88 (Ecallantide) to Treat Attacks of Hereditary Angioedema (HAE)
The purpose of this study is to evaluate the efficacy and safety of repeated doses of ecallantide in the treatment of acute attacks of hereditary angioedema and to allow HAE patients continued access to ecallantide.
- Trial name
- NCT00456508
- Testing
- ecallantide
- Where
- 41 sites in United States, Canada and 1 more
- Volunteers
- 147 people
- Sponsor
- Shire
Angioedema
Subcutaneous Treatment With Icatibant for Acute Attacks of Hereditary Angioedema
The purpose of this study is to assess the efficacy and safety of Icatibant, a bradykinin antagonist in the treatment of acute cutaneous and/or abdominal attacks in patients with hereditary angioedema (HAE).
- Trial name
- NCT00097695
- Testing
- Icatibant
- Where
- United States
- Volunteers
- 84 people
- Sponsor
- Shire
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.
Chronic Spontaneous Urticaria
OPTIMA: Efficacy of Optimized Re-treatment and Step-up Therapy With Omalizumab in Chronic Spontaneous Urticaria (CSU) Patients
This trial assessed the efficacy of optimized re-treatment therapy with omalizumab (150mg or 300mg) after relapse, in participants with Chronic Spontaneous Urticaria who were clinically well-controlled following their first…
- Trial name
- OPTIMA (NCT02161562)
- Testing
- omalizumab
- Where
- 35 sites in Argentina, Brazil and 6 more
- Volunteers
- 314 people
- Sponsor
- Novartis Pharmaceuticals
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