Trial Outcomes & Findings for Primary Immunodeficiency in Kuwait (NCT NCT03618147)

NCT ID: NCT03618147

Last Updated: 2019-09-09

Results Overview

Recruitment status

COMPLETED

Target enrollment

314 participants

Primary outcome timeframe

15 years

Results posted on

2019-09-09

Participant Flow

Participant milestones

Participant milestones
Measure	PID Patients All patients who were diagnosed with primary immunodeficiency
Overall Study STARTED	314
Overall Study COMPLETED	314
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Primary Immunodeficiency in Kuwait

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	PID Arab Patients n=314 Participants All patients diagnosed with PID
Age, Categorical <=18 years	295 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	19 Participants n=99 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants
Sex: Female, Male Female	149 Participants n=99 Participants
Sex: Female, Male Male	165 Participants n=99 Participants
Race/Ethnicity, Customized Arab patients	314 participants n=99 Participants

PRIMARY outcome

Timeframe: 15 years

Population: PID patients

Outcome measures

Outcome measures
Measure	PID Patients n=314 Participants All patients who were diagnosed with primary immunodeficiency
Number of Participants With Different Epidemiological Features Kuwaiti patients	287 patients
Number of Participants With Different Epidemiological Features immunodeficiencies affecting cellular and humoral	100 patients
Number of Participants With Different Epidemiological Features combined immunodeficiencies with associated syndro	68 patients
Number of Participants With Different Epidemiological Features predominantly antibody deficiencies	56 patients
Number of Participants With Different Epidemiological Features diseases of immune dysregulation	47 patients
Number of Participants With Different Epidemiological Features Phagocytic defects	20 patients
Number of Participants With Different Epidemiological Features autoinflammatory disorders	1 patients
Number of Participants With Different Epidemiological Features Complement deficiencies	22 patients
Number of Participants With Different Epidemiological Features Parental consanguinity	245 patients
Number of Participants With Different Epidemiological Features Family history of PID	157 patients
Number of Participants With Different Epidemiological Features Genetic testing	217 patients
Number of Participants With Different Epidemiological Features IVIG treatment	175 patients
Number of Participants With Different Epidemiological Features Stem cell transplant	72 patients
Number of Participants With Different Epidemiological Features Deaths	81 patients

PRIMARY outcome

Timeframe: 15 years

Outcome measures

Outcome measures
Measure	PID Patients n=314 Participants All patients who were diagnosed with primary immunodeficiency
Number of Overall and New Cases of PID Per 100,000 Kuwaitis Overall Cases	20 Cases per 100,000 Kuwaiti
Number of Overall and New Cases of PID Per 100,000 Kuwaitis New Cases	25 Cases per 100,000 Kuwaiti

Adverse Events

PID Patients

Serious events: 0 serious events

Other events: 0 other events

Deaths: 81 deaths

Serious adverse events

Serious adverse events
Measure	PID Patients All patients who were diagnosed with primary immunodeficiency
General disorders	— 0/0 • 15 years Serious Adverse Events and Other (Not Including Serious) Adverse Events" were not monitored/assessed

Other adverse events

Adverse event data not reported

Additional Information

Kuwait Society of Allergy & Clinical Immunology

Phone: 0096524636478

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place