Register for Pediatric Patients With Antiphospholipid Syn... | NCT00616317

Studies
Register for Pediatric Patients With Antiphospholipid Syndrome (APS): European Project Extended Internationally Study

NCT00616317

Sponsor

University of California, Davis

Status

Recruiting

Last Update Posted

Dec 5, 2025Actual

Enrollment

50Estimated

Phase

Not provided

Conditions

Antiphospholipid Syndrome

Interventions

Not provided

Countries

United States

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

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2006

Primary Completion Date

Jan 2040Estimated

Completion Date

Jan 2040Estimated

First Submitted Date

Feb 4, 2008

First Submission Date that Met QC Criteria

Feb 14, 2008

First Posted Date

Feb 15, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

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

Dec 3, 2025

Last Update Posted Date

Dec 5, 2025Actual

Name	Class
Ministry of Higher Education, Science and Technology, Solvenia	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Measure	Description	Time Frame
Long term survival		10 year

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

18 years of age or younger at the onset of disease
Presence of Vascular Thrombosis
UC Davis patient
Presence of at least one Laboratory criteria including: Anticardiolipin antibody, Anti-B glycoprotein-I antibody or Lupus anticoagulant in plasma

Exclusion Criteria:

Infants born to mothers with APS
Infants with congenital thrombophilia

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Minute

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Pediatric Nephrology Clinic at University of California, Davis

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Lavjay Butani	Contact	(916) 734-8118

Overall Officials

Name	Affiliation	Role
Lavjay Butani, M.D.	University of California, Davis	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UC Davis Medical Center	Recruiting	Sacramento	California	95817	United States

Label	URL
Learn more or sign up for the study here!	View source

Condition Browse Module

MeSH Terms

ID	Term
D016736	Antiphospholipid Syndrome

Ancestor Terms

ID	Term
D001327	Autoimmune Diseases
D007154	Immune System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided