Phase 4 Vasculitis Trial, Recruiting NCT06978439 Sponsor: Children's Hospital of Fudan University Condition: Vasculitis
Back to Vasculitis

Phase 4 Vasculitis Trial, Recruiting

NCT06978439
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:

  • You have been diagnosed with large balloon-like bulges (called giant aneurysms) in one or more of the heart's blood vessels following Kawasaki disease, confirmed by heart ultrasound with specific measurements meeting set thresholds
  • Your doctors recommend taking a combination of blood-thinning and anti-clotting medicines for at least the next 6 months
  • You are able to take medicines by mouth, or through a feeding tube into the nose or stomach
  • You are a child between 1 month and under 18 years of age, and weigh at least 2,600 grams (about 5.7 pounds)

Who may not be able to join:

  • You are currently bleeding or have a condition that makes blood-thinning medicines too dangerous to use
  • You have a history of blood clots in the veins, or conditions that raise the risk of them, such as certain heart defects, cancer, a central line (large IV), or being unable to move around for long periods
  • You have had a serious allergic reaction or other reason you cannot take the medicines being studied
  • Your kidneys are not working well enough (confirm with trial site for specific test values)
  • Your platelet count (cells that help blood clot) is too low
  • You have significant liver disease affecting blood clotting or with certain abnormal liver test results (confirm with trial site for specific values)
  • You have high blood pressure that is not being controlled, based on readings above the normal range for your age
  • You are currently taking certain strong medicines used for HIV or certain fungal infections that could interfere with the study medicines (confirm with trial site for the specific list)
  • You are currently taking certain medicines for infections or seizures that could interfere with the study medicines, including rifampicin, phenobarbital, phenytoin, or carbamazepine
  • You are unable or unwilling to follow the study schedule and attend follow-up visits
  • You or your guardian are not willing to give 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 28 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
10 January 2024
Est. completion
31 December 2025

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Occurrence of new thrombosis in coronary arteries; Composite of Major bleeding or Clinically relevant non-major bleeding 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: 28 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