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Primary Immunodeficiency in Kuwait

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ClinicalTrials.gov Identifier: NCT03618147
Recruitment Status : Completed
First Posted : August 7, 2018
Results First Posted : September 4, 2019
Last Update Posted : September 9, 2019
Sponsor:
Information provided by (Responsible Party):
Waleed Al-Herz, Kuwait Society for Allergy and Clinical Immunology

Brief 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

Condition or disease
Primary Immune Deficiency Disorder

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Study Type : Observational [Patient Registry]
Actual Enrollment : 314 participants
Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration: 5 Years
Official Title: Kuwait National Primary Immunodeficiency Registry (KNPIDR)
Actual Study Start Date : July 16, 2018
Actual Primary Completion Date : May 1, 2019
Actual Study Completion Date : May 1, 2019





Primary Outcome Measures :
  1. Number of Participants With Different Epidemiological Features [ Time Frame: 15 years ]
  2. Number of Overall and New Cases of PID Per 100,000 Kuwaitis [ Time Frame: 15 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
PIDD patients in Kuwait
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03618147


Locations
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Kuwait
Pediatric Deprtmemt, Alsabah hospital
Kuwait, Kuwait
Sponsors and Collaborators
Kuwait Society for Allergy and Clinical Immunology
  Study Documents (Full-Text)

Documents provided by Waleed Al-Herz, Kuwait Society for Allergy and Clinical Immunology:
Study Protocol  [PDF] July 22, 2019
No Statistical Analysis Plan (SAP) exists for this study.


Additional Information:

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Responsible Party: Waleed Al-Herz, Associate Professor of Pediatrics, Kuwait Society for Allergy and Clinical Immunology
ClinicalTrials.gov Identifier: NCT03618147     History of Changes
Other Study ID Numbers: IIR - K W T - 0 0 2 0 7 1
First Posted: August 7, 2018    Key Record Dates
Results First Posted: September 4, 2019
Last Update Posted: September 9, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Immunologic Deficiency Syndromes
Immune System Diseases