- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03618147
Primary Immunodeficiency in Kuwait
September 5, 2019 updated by: Waleed Al-Herz, Kuwait Society for Allergy and Clinical Immunology
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
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
314
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Kuwait, Kuwait
- Pediatric Deprtmemt, Alsabah hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
PIDD patients in Kuwait
Description
Inclusion Criteria:
- 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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of Participants With Different Epidemiological Features
Time Frame: 15 years
|
15 years
|
Number of Overall and New Cases of PID Per 100,000 Kuwaitis
Time Frame: 15 years
|
15 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
July 16, 2018
Primary Completion (ACTUAL)
May 1, 2019
Study Completion (ACTUAL)
May 1, 2019
Study Registration Dates
First Submitted
July 30, 2018
First Submitted That Met QC Criteria
August 3, 2018
First Posted (ACTUAL)
August 7, 2018
Study Record Updates
Last Update Posted (ACTUAL)
September 9, 2019
Last Update Submitted That Met QC Criteria
September 5, 2019
Last Verified
September 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IIR - K W T - 0 0 2 0 7 1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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