Antiphospholipid SyndromeAPSNCT00616317
Register for Pediatric Patients With Antiphospholipid Syndrome (APS): European Project Extended Internationally Study
An observational study of Antiphospholipid Syndrome, run by University of California, Davis at 1 site in United States.
Trial summary
The purpose of this study is to gather information about causes and treatment of Antiphospholipid Syndrome. Read more about this study
- Who is it for?
- Ages 1 minute to 18 years
- Conditions the study is for
- Antiphospholipid Syndrome
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2006to Jan 2040
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 minute to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Pediatric Nephrology Clinic at University of California, Davis
Who may be able to join
- 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
Who cannot join
- Infants born to mothers with APS
- Infants with congenital thrombophilia
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Lavjay Butani contact
United States1 site, 1 recruiting
- Recruiting
UC Davis Medical Center
Sacramento, California, 95817
About this study
The purpose of this study is to gather information about causes and treatment of Antiphospholipid Syndrome.
- Conditions
- Antiphospholipid Syndrome
- Keywords
- Antiphospholipid Syndrome
- Medical subject headings
- Antiphospholipid Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
Long term survival
Measured: 10 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2008 (estimated)
- Study startSep 2006
- Primary completionJan 2040 (estimated)
- Study completionJan 2040 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Antiphospholipid SyndromeStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Higher Education, Science and Technology, Solvenia
- Responsible party
- Sponsor
- Investigators
- Lavjay Butani, M.D., Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00616317
- Sponsor's protocol ID
- 235519
- Acronym
- APS
- Status last verified
- Dec 2025
- First submitted
- 4 Feb 2008
- Last updated
- 5 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Register for Pediatric Patients With Antiphospholipid Syndrome (APS): European Project Extended Internationally Study
- ClinicalTrials.gov ID
- NCT00616317
- Acronym / sponsor ID
- APS / 235519
- Conditions
- Antiphospholipid Syndrome
- Keywords
- Antiphospholipid Syndrome
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Collaborators
- Ministry of Higher Education, Science and Technology, Solvenia
- Study start
- Sep 2006
- Primary completion
- Jan 2040 (estimated)
- Study completion
- Jan 2040 (estimated)
- First posted
- 15 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to gather information about causes and treatment of Antiphospholipid Syndrome.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 1 minute to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Pediatric Nephrology Clinic at University of California, Davis
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Infants born to mothers with APS
- Infants with congenital thrombophilia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Long term survival
Time frame: 10 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2025.
- Learn more or sign up for the study here!Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lavjay Butani contact
Lavjay Butani, M.D. principal investigator
University of California, Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Antiphospholipid Syndrome, run by University of California, Davis at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lavjay Butani ((916) 734-8118), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Long term survival (time frame: 10 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2025.