An observational study in Hereditary Angioedema With C1 Esterase Inhibitor Deficiency, sponsored by Hospital Universitari Vall d'Hebron Research Institute. Not yet recruiting at 2 sites in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-04-27.
Sponsored by Hospital Universitari Vall d'Hebron Research Institute · Observational
Among 37 studies in Angioedemas, Hereditary with a site in Spain — 9 open to participants now, 14 under way, 11 of them phase 3. Angioedemas, Hereditary · Spain.
Among the 37 studies in Angioedemas, Hereditary with a site in Spain, this one is the only one that started in 2023, is one of 5 observational ones, reaches primary completion later than 1 of the 13 other live ones, and was the 27th registered.
171 studies on the registry are indexed under Angioedemas, Hereditary; 24 are open to participants now.
Browse Angioedemas, Hereditary studies →9 of the 37 studies in Angioedemas, Hereditary with a site in Spain are open now. Recruiting first, the newest first:
Ionis Pharmaceuticals, Inc. · Sites in Spain, United States, Australia and 2 more countries
ADARx Pharmaceuticals, Inc. · Sites in Spain, United States, Argentina and 16 more countries
Pharvaris Netherlands B.V. · Sites in Spain, United States, Australia and 13 more countries
ADARx Pharmaceuticals, Inc. · Sites in Spain, United States, Argentina and 21 more countries
Astria Therapeutics, Inc. · Sites in Spain, United States, Brazil and 15 more countries
A study can be open while its sites in Spain have not opened yet or have stopped. Only those recruiting at a site in Spain →
Of the 13 Angioedemas, Hereditary studies recruiting now, 9 (69%) set no upper age limit and 4 (31%) stop at 75 or younger; 7 take children under 18; 1 take healthy volunteers.
This study: 18 Years and older · all sexes.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
37 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 1 · Phase 2 8 · Phase 3 26
First in 2005; this study’s year is marked. 1 started in 2023.
This study's planned enrollment of 200 is above the median of 100 across 43 observational studies indexed under Angioedemas, Hereditary.
Median enrollment 90 across the 31 interventional studies, 200 across the 5 observational. Of the 22 that completed or were terminated, 14 (64%) have results posted.
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36 of 37 have an industry lead sponsor. The 10 most frequent:
Hospital Universitari Vall d'Hebron Research Institute is the lead sponsor of 276 studies on the registry; 64 are open to participants now.
Hospital Universitari Vall d'Hebron Research Institute has 1 study filed under Angioedemas, Hereditary — fewer than ten, so there is no comparison to draw.
5 of the studies in Angioedemas, Hereditary with a site in Spain that are under way reach primary completion within a year, 5 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06842823Phase 3Astria Therapeutics, Inc.A Study of Navenibart in Participants With Hereditary Angioedema | 2026-12 |
| NCT05392114Phase 3Ionis Pharmaceuticals, Inc.A Study to Assess the Long-Term Safety and Efficacy of Donidalorsen in the Prophylactic Treatment of Hereditary Angioedema (HAE) | 2026-12 |
| NCT05396105Phase 3Pharvaris Netherlands B.V.Extension Study of Oral PHA-022121 for Acute Treatment of Angioedema Attacks in Patients With Hereditary Angioedema | 2027-06 |
| NCT07266805Phase 3Pharvaris Netherlands B.V.Study of Oral Deucrictibant XR Tablet for Prophylaxis and Deucrictibant Soft Capsule for On-Demand Treatment of Angioedema Attacks in Adults With Acquired Angioedema Due to C1 Inhibitor Deficiency | 2027-06 |
| NCT06960213Phase 3ADARx Pharmaceuticals, Inc.STOP-HAE: A Phase 3 Study of ADX-324 in HAE | 2027-11-30 |
Among the 37 studies in Angioedemas, Hereditary with a site in Spain, from their registry updates:
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This project aims to analyse in an unbiased way the existence of genetic variants that contribute to explaining and predicting the differences in clinical expression between patients with HAE.
Adult patients with hereditary angioedema with C1INH deficiency (HAE-C1INH) from different regions of Spain will be included. Patients included in the study will be divided into two groups: a) symptomatic (≥ 18 years old), which will be those who present symptoms compatible with HAE-C1INH and who have a confirmed diagnosis and b) asymptomatic patients (≥ 22 years old), which will be those with a C1INH deficiency and who have not developed symptoms of HAE.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adult patients (≥ 18 years old) with hereditary angioedema with C1INH deficiency (HAE-C1INH) from different regions of Spain will be included. Patients included in the study will be divided into two groups: a) symptomatic, which will be those who present symptoms compatible with HAE-C1INH and who have a confirmed diagnosis
Asymptomatic patients, which will be those with a C1INH deficiency and who have not developed symptoms of HAE. Asymptomatic patients must be at least 22 years old and meet the same criteria than those symptomatic, except for the presence of symptoms consistent with HAE-C1INH
Set of validated disease-modifying genetic variants in Spanish patients with HAE-C1INH
To identify and characterize novel genetic variants associated with the incomplete penetrance and variable clinical expressivity observed in HAE-C1INH patients.
Time frame: Day 1
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for May 2023; primary completion for Mar 2026, 34 months later.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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Hospital Universitari Vall d'Hebron Research Institute →