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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

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Other
Condition Primary Immune Deficiency Disorder
Enrollment 314
Recruitment Details  
Pre-assignment Details  
Arm/Group Title PID Patients
Hide Arm/Group Description All patients who were diagnosed with primary immunodeficiency
Period Title: Overall Study
Started 314
Completed 314
Not Completed 0
Arm/Group Title PID Arab Patients
Hide Arm/Group Description All patients diagnosed with PID
Overall Number of Baseline Participants 314
Hide Baseline Analysis Population Description
All PID patients
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 314 participants
<=18 years
295
  93.9%
Between 18 and 65 years
19
   6.1%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 314 participants
Female
149
  47.5%
Male
165
  52.5%
Race/Ethnicity, Customized   [1] 
Measure Type: Number
Unit of measure:  Participants
Arab patients Number Analyzed 314 participants
314
[1]
Measure Description: All patients are Arab
1.Primary Outcome
Title Number of Participants With Different Epidemiological Features
Hide Description [Not Specified]
Time Frame 15 years
Hide Outcome Measure Data
Hide Analysis Population Description
PID patients
Arm/Group Title PID Patients
Hide Arm/Group Description:
All patients who were diagnosed with primary immunodeficiency
Overall Number of Participants Analyzed 314
Measure Type: Number
Unit of Measure: patients
Kuwaiti patients 287
immunodeficiencies affecting cellular and humoral 100
combined immunodeficiencies with associated syndro 68
predominantly antibody deficiencies 56
diseases of immune dysregulation 47
Phagocytic defects 20
autoinflammatory disorders 1
Complement deficiencies 22
Parental consanguinity 245
Family history of PID 157
Genetic testing 217
IVIG treatment 175
Stem cell transplant 72
Deaths 81
2.Primary Outcome
Title Number of Overall and New Cases of PID Per 100,000 Kuwaitis
Hide Description [Not Specified]
Time Frame 15 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title PID Patients
Hide Arm/Group Description:
PID Arab patients
Overall Number of Participants Analyzed 314
Measure Type: Number
Unit of Measure: Cases per 100,000 Kuwaiti
Overall Cases 20
New Cases 25
Time Frame 15 years
Adverse Event Reporting Description Serious Adverse Events and Other (Not Including Serious) Adverse Events” were not monitored/assessed
 
Arm/Group Title PID Patients
Hide Arm/Group Description All patients who were diagnosed with primary immunodeficiency
All-Cause Mortality
PID Patients
Affected / at Risk (%)
Total   81/314 (25.80%) 
Show Serious Adverse Events Hide Serious Adverse Events
PID Patients
Affected / at Risk (%)
Total   0/0 
General disorders   
 *  0/0 
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
PID Patients
Affected / at Risk (%)
Total   0/0 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Kuwait Society of Allergy & Clinical Immunology
Organization: Kuwait Society of Allergy & Clinical Immunology
Phone: 0096524636478
EMail: walherz@hsc.edu.kw
Layout table for additonal information
Responsible Party: Waleed Al-Herz, 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 Submitted: July 30, 2018
First Posted: August 7, 2018
Results First Submitted: May 10, 2019
Results First Posted: September 4, 2019
Last Update Posted: September 9, 2019