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NCT03618147 Clinical Trial

Primary Immunodeficiency in Kuwait

Primary Immune Deficiency Disorder Clinical Trial

Official title:
Kuwait National Primary Immunodeficiency Registry (KNPIDR)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03618147
Other study ID # IIR - K W T - 0 0 2 0 7 1
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 16, 2018
Est. completion date May 1, 2019

Study information
Verified date September 2019
Source Kuwait Society for Allergy and Clinical Immunology
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical 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. 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

Recruitment information / eligibility
Status Completed
Enrollment 314
Est. completion date May 1, 2019
Est. primary completion date May 1, 2019
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 Design

Related Conditions & MeSH terms

Locations
Country Name City State
Kuwait Pediatric Deprtmemt, Alsabah hospital Kuwait

Sponsors (1)
Lead Sponsor Collaborator
Kuwait Society for Allergy and Clinical Immunology

Country where clinical trial is conducted

Kuwait, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of Participants With Different Epidemiological Features 15 years
Primary Number of Overall and New Cases of PID Per 100,000 Kuwaitis 15 years
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