NCT03618147

Primary Immunodeficiency in Kuwait

Completed Results posted Last updated 9 September 2019

What this trial tests

trial in Primary Immune Deficiency Disorder in 314 participants. Completed in 1 May 2019.

Timeline

16 July 2018

Primary endpoint
1 May 2019

1 May 2019

Quick facts

Lead sponsor	Kuwait Society for Allergy and Clinical Immunology
Status	Completed
Study type	OBSERVATIONAL
Enrollment	314
Start date	16 July 2018
Primary completion	1 May 2019
Estimated completion	1 May 2019
Sites	1 location across Kuwait

Conditions studied

• Primary Immune Deficiency Disorder — all drugs for Primary Immune Deficiency Disorder →

Sponsor

Kuwait Society for Allergy and Clinical Immunology

Who can join

Eligibility, any sex, with Primary Immune Deficiency Disorder. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Different Epidemiological Features Primary · 15 years

Kuwaiti patients

Group	Value	95% CI
PID Patients	287

immunodeficiencies affecting cellular and humoral

Group	Value	95% CI
PID Patients	100

combined immunodeficiencies with associated syndro

Group	Value	95% CI
PID Patients	68

predominantly antibody deficiencies

Group	Value	95% CI
PID Patients	56

diseases of immune dysregulation

Group	Value	95% CI
PID Patients	47

Phagocytic defects

Group	Value	95% CI
PID Patients	20

autoinflammatory disorders

Group	Value	95% CI
PID Patients	1

Complement deficiencies

Group	Value	95% CI
PID Patients	22

Number of Overall and New Cases of PID Per 100,000 Kuwaitis Primary · 15 years

Overall Cases

Group	Value	95% CI
PID Patients	20

New Cases

Group	Value	95% CI
PID Patients	25

Adverse events — posted to ClinicalTrials.gov

Time frame: 15 years. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

PID Patients

Serious: 0

Deaths: 81/314

Serious adverse events (1 terms)

Reaction	System	PID Patients
	General disorders	—

Most-reported serious reactions: .

Data from ClinicalTrials.gov NCT03618147 adverse events section.

Sponsor's own description

* 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

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.