Skip to main content
OpenTrials
Completed

NCT Number: NCT00581763

Long-Term Outcome of Children and Adolescents With Anti-Phospholipid Antibodies

This is a study about why some people have certain types of proteins in their blood, called anti-phospholipid antibodies. The presence of these antibodies and associated complications (e.g. blood clots) are known to change over time. The purpose of this study is to evaluate these changes and improve our ability to determine the long-term outcome of affected individuals.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

Up to 21 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of California, San Francisco

San Francisco, California, 94143, United States

About this study

Aim:

  • Determine the incidence, and time frame, for aquiring aPL in a cohort of aPL-negative pediatric SLE subjects.
  • Determine the incidence, and time frame, for developing a first APS-associated complication among SLE subjects with detectable aPL.
  • Determine the incidence, and time frame, for developing a second APS-associated event among subjects with a history of an APS-associated event.
  • Determine the incidence, and time frame, for developing SLE among subjects with a history of an APS-associated event in the absence of SLE.
  • Identify laboratory and clinical predictors for the events described in aims 1-4.Research Design and Methods:

This is a prospective cohort study to determine the risk of developing aPL or APS-related symptoms in a young group of SLE and APS subjects. Patients will be followed over a ten year period and will undergo annual serologic and clinical evaluations to identify disease progression.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Age: Less than 21 years at baseline exam

  • Diagnosis: patients must meet criteria for one of five diagnostic categories based on classification according to three parameters; aPL positivity, APS criteria, and SLE criteria.

The five diagnostic categories are:

  • SLE with no aPL
  • SLE with aPL, but without manifestations of APS
  • SLE-like APS
  • SLE with APS
  • Primary APS.

Exclusion criteria

  • none

Treatment and study plan

Primary outcomes

  1. thrombosis

    Time frame: Ten years

    blood clot

Secondary outcomes

  1. lupus

    Time frame: 10 years

    systemic lupus erythematosus

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Acronym: APL

Important dates

Study start
2001
Primary completion
2019
Study completion
2019
First posted
Dec 28, 2007
Registry last updated
Dec 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.