Primary Immunodeficiency in Kuwait | NCT03618147

Studies
Primary Immunodeficiency in Kuwait

NCT03618147

Sponsor

Kuwait Society for Allergy and Clinical Immunology

Status

Completed

Last Update Posted

Sep 9, 2019Actual

Enrollment

314Actual

Phase

Not provided

Conditions

Primary Immune Deficiency Disorder

Interventions

Not provided

Countries

Kuwait

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

Participant Flow Module

Pre-assignment Details

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 16, 2018Actual

Primary Completion Date

May 1, 2019Actual

Completion Date

May 1, 2019Actual

First Submitted Date

Jul 30, 2018

First Submission Date that Met QC Criteria

Aug 3, 2018

First Posted Date

Aug 7, 2018Actual

Results Waived

Not provided

Results First Submitted Date

May 10, 2019

Results First Submitted that Met QC Criteria

Jul 25, 2019

Results First Posted Date

Sep 4, 2019Actual

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 5, 2019

Last Update Posted Date

Sep 9, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Waleed Al-Herz, Associate Professor of Pediatrics, Kuwait Society for Allergy and Clinical ImmunologyPrincipal Investigator

Lead Sponsor

Kuwait Society for Allergy and Clinical ImmunologyOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

5 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

314Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants With Different Epidemiological Features		15 years
Number of Overall and New Cases of PID Per 100,000 Kuwaitis		15 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

PIDD patients in Kuwait

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Pediatric Deprtmemt, Alsabah hospital		Kuwait City			Kuwait

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Title	Description
FG000	PID Patients	All patients who were diagnosed with primary immunodeficiency

Baseline Characteristics Module

Baseline Analysis Population Description

All PID patients

Type of Units Analyzed

Not provided

Arm/Group Information

ID	Title	Description
BG000	PID Arab Patients	All patients diagnosed with PID

Denominators

Units	Counts
Participants	BG000

Baseline Measures

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Categorical			Count of Participants

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Number of Participants With Different Epidemiological Features

PID patients

Posted

Number

patients

15 years

ID	Title	Description
OG000	PID Patients	All patients who were diagnosed with primary immunodeficiency

Units	Counts
Participants	OG000

Adverse Events Module

Frequency Threshold

Time Frame

15 years

Description

Serious Adverse Events and Other (Not Including Serious) Adverse Events" were not monitored/assessed

All-Cause Mortality Comment

Not provided

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	PID Patients	All patients who were diagnosed with primary immunodeficiency	81

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
	General disorders		Non-systematic Assessment

Other Adverse Events

Not provided

More Info Module

Limitations and Caveats

Not provided

Certain Agreements

Are all PI(s) employees of the sponsor?

Restriction Type

Point of Contact

Title	Organization	Phone	Extension	Email
Kuwait Society of Allergy & Clinical Immunology	Kuwait Society of Allergy & Clinical Immunology	0096524636478		walherz@hsc.edu.kw

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jul 22, 2019	Jul 22, 2019	Prot_000.pdf

Condition Browse Module

MeSH Terms

ID	Term
D000081207	Primary Immunodeficiency Diseases

Ancestor Terms

ID	Term
D030342	Genetic Diseases, Inborn
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities
D007153	Immunologic Deficiency Syndromes
D007154	Immune System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided