Phase 4 Vasculitis Trial, Recruiting NCT05643651 Sponsor: Children's Hospital of Fudan University Condition: Vasculitis
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Phase 4 Vasculitis Trial, Recruiting

NCT05643651
Recruiting Phase 4

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • Children aged 2 years or older who have developed large coronary artery aneurysms (abnormal bulges in the heart's blood vessels) following the active stage of Kawasaki disease, confirmed by ultrasound imaging and meeting specific size measurements
  • Children for whom doctors recommend a combination of blood-thinning and anti-clotting medications for at least the next 3 months
  • Children who are able to take medications by mouth, or through a feeding tube into the stomach or nose

Who may not be able to join:

  • Children who are currently bleeding or who have a condition that makes blood-thinning medication too risky
  • Children with a history of blood clots in the veins, or conditions that increase that risk, such as certain heart defects present from birth, cancer, a central venous catheter, or long periods of being unable to move
  • Children in whom a blood clot has already been found inside a coronary artery aneurysm, confirmed by imaging such as ultrasound, CT scan, or coronary angiography
  • Children whose kidneys are not working well enough, based on specific blood test measurements (confirm with trial site)
  • Children with a low platelet count in their blood (platelets help blood to clot)
  • Children with a liver condition that affects blood clotting or shows significantly abnormal liver test results
  • Children with persistently uncontrolled high blood pressure for their age
  • Children currently taking certain strong medications that interfere with how the body processes the study drug, including some HIV medications and certain antifungal treatments taken throughout the body (confirm with trial site)
  • Children currently taking certain medications that speed up the body's breakdown of the study drug, including some antibiotics and some anti-seizure medications (confirm with trial site)
  • Children with a known allergy or medical reason that rules out the use of the study medications
  • Children or families who are unable to participate in the required study procedures and follow-up visits
  • Families who do not provide consent to participate in the study

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 26 July 2026
Phase 4 trials study a drug that has already been approved, monitoring long-term safety and effectiveness in real-world use.

Contact this trial

Principal Investigator: Fang Liu, MD, Children's Hospital of Fudan University

Phone: 18017590880

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 4
Sponsor
Children's Hospital of Fudan University
Registry
ClinicalTrials.gov
Start date
1 June 2025
Est. completion
1 June 2027

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Composite of new thrombosis in coronary arteries, major bleeding, clinically relevant non-major bleeding event or major adverse cardiovascular event

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 26 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov