Hereditary AngioEdemaHAENPNCT02159430
Hereditary AngioEdema, Neurobiology and Psychopathology
An observational study of Hereditary AngioEdema and Anxiety, run by University Hospital, Catania at 1 site in Italy.
Trial summary
Since 1963 Hereditary AngioEdema (HAE) is considered an autosomal dominant disorder (Donaldson and Evans), characterized by a quantitative and/or qualitative deficit of C1 esterase inhibitor (C1-INH), which affects approximately 1:50.000 individuals in the general population. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hereditary AngioEdema, Anxiety, Depression
- What is being tested?
- Clinical and psychopathological assessment of HAE patients
- How many people
- 35 participants
- Where
- 1 siteItaly
- Study dates
- Nov 2014to May 2015
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This population-based cross-sectional study will include all Hereditary AngioEdema (HAE) patients from the Eastern Sicily HAE register.
Who may be able to join
- Diagnosis of HAE
Who cannot join
- Current pharmacological treatment including ACE-inhibitors, ACE inhibitors, glucocorticoids, oestroprogestative, psychotropic drugs, drugs acting on the immune system (15 days before), anesthetics (in the previous three months).
- Inflammation / infection (eg, chronic inflammatory diseases, acute) in the last 15 days.
- Ongoing allergies.
- Night work over the past 15 days.
- Vigorous physical activity or alcohol consumption (the day before the assessment).
- Women in follicular phase of menstrual cycle.
Trial locations and contacts
1 site in 1 country.
Italy1 site
UOPI of psychiatry - Department of clinical and molecular biomedicine - AOU Policlinico-Vittorio Emanuele
Catania, Catania, 95024
Giuseppe Minutolo, MD, PhD, giuseppeminutolo@hotmail.com
Francesca Magnano S. Lio, MD, francesca.magnanosanlio@gmail.com
About this study
Since 1963 Hereditary AngioEdema (HAE) is considered an autosomal dominant disorder (Donaldson and Evans), characterized by a quantitative and/or qualitative deficit of C1 esterase inhibitor (C1-INH), which affects approximately 1:50.000 individuals in the general population. From this period the link between HAE and psychiatry was interrupted, however genetic issues could not comprehensively explain the clinical evolution of the disease. Clinical studies show an evident gap between genotype and phenotype of HAE. For this still controversial question, we have designed this cross-sectional study in order to establish the relationship between HAE clinical manifestations and neurobiological/psychopatological parameters.
- Conditions
- Hereditary AngioEdema, Anxiety, Depression
- Being tested
- Clinical and psychopathological assessment of HAE patients
- Medical subject headings
- Angioedemas, Hereditary, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical and psychopathological assessment of HAE patientsOther
| Study group | Role | What they receive |
|---|---|---|
| HereditaryAngioEdema | Patients from the Eastern Sicily HAE register Receives: Other: Clinical and psychopathological assessment of HAE patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Multivariate linear regression analysis of HAE clinical status and psychometric parameters
Measured: First assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2014 (estimated)
- Study startNov 2014
- Primary completionFeb 2015 (estimated)
- Study completionMay 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hereditary AngioEdemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 35 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- University Hospital, Catania
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Eugenio Aguglia, University Hospital, Catania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02159430
- Sponsor's protocol ID
- UHCatania1
- Acronym
- HAENP
- Status last verified
- Jun 2014
- First submitted
- 5 Jun 2014
- Last updated
- 10 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hereditary AngioEdema, Neurobiology and Psychopathology
- ClinicalTrials.gov ID
- NCT02159430
- Acronym / sponsor ID
- HAENP / UHCatania1
- Conditions
- Hereditary AngioEdema, Anxiety, Depression
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- University Hospital, CataniaUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Feb 2015 (estimated)
- Study completion
- May 2015 (estimated)
- First posted
- 10 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Since 1963 Hereditary AngioEdema (HAE) is considered an autosomal dominant disorder (Donaldson and Evans), characterized by a quantitative and/or qualitative deficit of C1 esterase inhibitor (C1-INH), which affects approximately 1:50.000 individuals in the general population. From this period the link between HAE and psychiatry was interrupted, however genetic issues could not comprehensively explain the clinical evolution of the disease. Clinical studies show an evident gap between genotype and phenotype of HAE. For this still controversial question, we have designed this cross-sectional study in order to establish the relationship between HAE clinical manifestations and neurobiological/psychopatological parameters.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HereditaryAngioEdema | – | Other: Clinical and psychopathological assessment of HAE patientsPatients from the Eastern Sicily HAE register |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This population-based cross-sectional study will include all Hereditary AngioEdema (HAE) patients from the Eastern Sicily HAE register.
Key inclusion criteria (1 listed)
- Diagnosis of HAE
Key exclusion criteria (6 listed)
- Current pharmacological treatment including ACE-inhibitors, ACE inhibitors, glucocorticoids, oestroprogestative, psychotropic drugs, drugs acting on the immune system (15 days before), anesthetics (in the previous three months).
- Inflammation / infection (eg, chronic inflammatory diseases, acute) in the last 15 days.
- Ongoing allergies.
- Night work over the past 15 days.
- Vigorous physical activity or alcohol consumption (the day before the assessment).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical and psychopathological assessment of HAE patients | Other | HereditaryAngioEdema |
Primary outcome
Multivariate linear regression analysis of HAE clinical status and psychometric parameters
Time frame: First assessment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hereditary AngioEdema and Anxiety, run by University Hospital, Catania at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Giuseppe Minutolo, MD, PhD (+39 0953782791, giuseppeminutolo@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Multivariate linear regression analysis of HAE clinical status and psychometric parameters (time frame: First assessment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2014.