Primary Immune Deficiency DisorderNCT03618147
Primary Immunodeficiency in Kuwait
An observational study of Primary Immune Deficiency Disorder, run by Kuwait Society for Allergy and Clinical Immunology at 1 site in Kuwait.
Trial summary
Background/Rationale: Epidemiological data about Primary Immunodeficiency Disorders (PIDD) in Kuwait is needed to better understand peculiarities and to compare them with other regions and ethnicity. Study hypothesis: PIDD is relatively common in Kuwait compared to populations from different geographic areas. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Primary Immune Deficiency Disorder
- How many people
- 314 participants
- Where
- 1 siteKuwait
- Study dates
- 16 Jul 2018to 1 May 2019
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: PIDD patients in Kuwait
Who may be able to join
- PIDD patients presented at different clinics/hospital in Kuwait
- Exclusion Criteria: Patients with secondary immunodeficiencies (drug induced, virus induced, and immunodeficiency associated with metabolic disorders... ect)
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Kuwait National Primary Immunodeficiency Registry (KNPIDR)
- Background/Rationale: Epidemiological data about Primary Immunodeficiency Disorders (PIDD) in Kuwait is needed to better understand peculiarities and to compare them with other regions and ethnicity.
- Study hypothesis: PIDD is relatively common in Kuwait compared to populations from different geographic areas. The distribution of PIDD in Kuwait is different from other geographic areas with more severe forms being more frequent.
- Brief inclusion and exclusion criteria of study participants: PIDD patients presented at different clinics/hospital in Kuwait. Patients with secondary immunodeficiencies (drug induced, virus induced, and immunodeficiency associated with metabolic disorders... ect), will be excluded
- Estimated sample size of the study: All patients who were registered in KNPIDR since 2004 will be included in the study along with the new patients who will be recruited during the study period.
- Primary objectives:
- Determine the prevalence and frequency of different PIDD in Kuwait
- Identify clinical presentation patterns for PIDD in Kuwait
- Identify natural history of PIDD in Kuwait
- Help to asses epidemiology of PIDD in Kuwait
- Determine particularities about PIDD affecting the population in Kuwait
- Determine the health impact of PIDD in Kuwait
- Development of strategies to improve the care and the quality of life of patients with PIDD
- Conditions
- Primary Immune Deficiency Disorder
- Medical subject headings
- Primary Immunodeficiency Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Different Epidemiological Features
Measured: 15 years
Number of Overall and New Cases of PID Per 100,000 Kuwaitis
Measured: 15 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2018
- Study start16 Jul 2018
- Primary completion1 May 2019
- Study completion1 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Primary Immune Deficiency DisorderStudies 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
- Other
- Enrolment
- 314 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Kuwait Society for Allergy and Clinical Immunology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Waleed Al-Herz, Kuwait Society for Allergy and Clinical Immunology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03618147
- Sponsor's protocol ID
- IIR - K W T - 0 0 2 0 7 1
- Status last verified
- Sep 2019
- First submitted
- 30 Jul 2018
- Last updated
- 9 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kuwait National Primary Immunodeficiency Registry (KNPIDR)
- ClinicalTrials.gov ID
- NCT03618147
- Acronym / sponsor ID
- IIR - K W T - 0 0 2 0 7 1
- Conditions
- Primary Immune Deficiency Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 314 participants (actual)
- Lead sponsor
- Kuwait Society for Allergy and Clinical ImmunologyUniversity, hospital or other
- Study start
- 16 Jul 2018 (actual)
- Primary completion
- 1 May 2019 (actual)
- Study completion
- 1 May 2019 (actual)
- First posted
- 7 Aug 2018 (actual)
- Results
- Posted 4 Sep 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- Background/Rationale: Epidemiological data about Primary Immunodeficiency Disorders (PIDD) in Kuwait is needed to better understand peculiarities and to compare them with other regions and ethnicity.
- Study hypothesis: PIDD is relatively common in Kuwait compared to populations from different geographic areas. The distribution of PIDD in Kuwait is different from other geographic areas with more severe forms being more frequent.
- Brief inclusion and exclusion criteria of study participants: PIDD patients presented at different clinics/hospital in Kuwait. Patients with secondary immunodeficiencies (drug induced, virus induced, and immunodeficiency associated with metabolic disorders... ect), will be excluded
- Estimated sample size of the study: All patients who were registered in KNPIDR since 2004 will be included in the study along with the new patients who will be recruited during the study period.
- Primary objectives:
- Determine the prevalence and frequency of different PIDD in Kuwait
- Identify clinical presentation patterns for PIDD in Kuwait
- Identify natural history of PIDD in Kuwait
- Help to asses epidemiology of PIDD in Kuwait
- Determine particularities about PIDD affecting the population in Kuwait
- Determine the health impact of PIDD in Kuwait
- Development of strategies to improve the care and the quality of life of patients with PIDD
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 5 Years
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- PIDD patients in Kuwait
Key inclusion criteria (2 listed)
- PIDD patients presented at different clinics/hospital in Kuwait
- Exclusion Criteria: Patients with secondary immunodeficiencies (drug induced, virus induced, and immunodeficiency associated with metabolic disorders... ect)
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of Participants With Different Epidemiological Features
Time frame: 15 years
Number of Overall and New Cases of PID Per 100,000 Kuwaitis
Time frame: 15 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Primary Immune Deficiency Disorder, run by Kuwait Society for Allergy and Clinical Immunology at 1 site in Kuwait.
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 2 inclusion and 0 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: finished, as of the sponsor's last update on 9 Sep 2019. 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 Kuwait. 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?
Yes. Results are posted in the registry (first posted 4 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Different Epidemiological Features (time frame: 15 years). The study lists 2 primary outcomes in all. 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 9 Sep 2019.