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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00616317
Recruitment Status : Recruiting
First Posted : February 15, 2008
Last Update Posted : May 30, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this study is to gather information about causes and treatment of Antiphospholipid Syndrome.

Condition or disease
Antiphospholipid Syndrome

Study Design

Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Register for Pediatric Patients With Antiphospholipid Syndrome (APS): European Project Extended Internationally Study
Study Start Date : September 2006
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Primary Outcome Measures :
  1. Long term survival [ Time Frame: 10 year ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Pediatric Nephrology Clinic at University of California, Davis
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00616317


Contacts
Contact: Lavjay Butani (916) 734-8118

Locations
United States, California
UC Davis Medical Center Recruiting
Sacramento, California, United States, 95817
Sponsors and Collaborators
University of California, Davis
Ministry of Higher Education, Science and Technology, Solvenia
Investigators
Principal Investigator: Lavjay Butani, M.D. University of California, Davis
More Information

Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT00616317     History of Changes
Other Study ID Numbers: 200614666-1
First Posted: February 15, 2008    Key Record Dates
Last Update Posted: May 30, 2017
Last Verified: October 2016

Keywords provided by University of California, Davis:
Antiphospholipid Syndrome

Additional relevant MeSH terms:
Syndrome
Antiphospholipid Syndrome
Disease
Pathologic Processes
Autoimmune Diseases
Immune System Diseases