Please select the eligibility criteria that correspond to the clinical trial below.
Title: To Evaluate the Efficacy and Safety of TA-650 in Comparison With a Control Drug Polyethylene Glycol-treated Human Immunoglobulin (VGIH) in Patients With Kawasaki Disease Refractory to Initial Therapy With Intravenous Immunoglobulin (IVIG).
Brief Summary: The purpose of this study is to evaluate the efficacy and safety of TA-650 in comparison with a control drug Polyethylene Glycol-treated Human Immunoglobulin (VGIH) in patients with Kawasaki disease refractory to initial therapy with Intravenous Immunoglobulin (IVIG). The pharmacokinetics of TA-650 is also examined.


Options:
A: Inclusion Criteria:

* Individual patient's medical file data confirmed the diagnosis of KD using the 5th revised edition of diagnostic criteria for KD, issued by the Japan Kawasaki Disease Research Committee at the 7th International Kawasaki Disease Symposium in 2002.
* the patients aged from 1 months to 12 years old.
* All included patients required to sign an informed consent form.
* the patients didn't receive treatment before.

Exclusion Criteria:

* The patients with the application of hormone or other immunosuppressive agents;
* The patients didn't want to signed informed consent.
B: Inclusion Criteria:

* Patients diagnosed with Kawasaki disease (incipient cases only) with 5 or more of the 6 major symptoms of Kawasaki disease.
* Patients refractory to initial IVIG therapy (a single administration at 2 g per kg body weight).
* Patients with a fever of 37.5ºC or higher axillary temperature at the time of enrollment.
* Patients to whom the study drug can be administered by day 8 of disease.

Exclusion Criteria:

* Patients who have received vaccination with Bacille Calmette-Guérin (BCG) vaccine within 6 months before the enrollment.
* Patients with a complication, or a history within 6 months before the enrollment of, serious infections requiring hospitalization.
* Patients with a complication, or a history within 6 months before the enrollment of, opportunistic infections.
* Patients complicated with active tuberculosis, active hepatitis B or C, or patients confirmed to be hepatitis B virus carriers or a history of hepatitis B.
* Patients confirmed to have HIV infection, or patients with a family history of HIV infection.
* Patients who have a history of receiving treatment with infliximab or other biological products.
* Patients who had participated in another clinical study and had received a study drug within 12 weeks before giving consent.
C: Inclusion Criteria:

* Meeting diagnostic criteria for Kawasaki disease (KD) released by American Heart Association (AHA) in 2017
* Diagnosed before the tenth day of illness (with the first day of illness defined as the first day of fever)
* Not treated with IVIG yet
* Age ≥1 month

Exclusion Criteria:

* Z score of any coronary artery before initial treatment ≥10
* Receiving steroids or other immunosuppressive agents in the previous 30 days
* With a previous history of KD
* Afebrile before enrolment
* With suspected infectious diseases including sepsis, septic meningitis, peritonitis, bacterial pneumonia, varicella and influenza
* With serious immune diseases such as immunodeficiency or chromosomal abnormalities
D: Inclusion Criteria:

* Eligible subjects will be as follows:

  1. 4 weeks to 17 years of age,
  2. fulfill the American Heart Association case definition for complete or incomplete KD,
  3. have had fever (T ≥38°C) for 3 to 10 days prior to initial IVIG treatment,
  4. have fever (T ≥38°C orally or rectally) between 36 hours and 7 days after end of the first IVIG infusion without other likely cause

Exclusion Criteria:

1. Patient treated with infliximab or steroids for present illness (pts who received oral steroids as outpatients prior to KD diagnosis but who otherwise qualify for the study will not be excluded)
2. Known prior infection with tuberculosis, coccidiomycosis, or histoplasmosis.

Answer: B