NCT03200561

A Trial to Evaluate the Efficacy of Immunoglobulin Plus Steroid for Prevention of Coronary Artery Abnormalities in Taiwanese Refractory Kawasaki Disease (RAST Study)

A Randomized Open-label Trial to Evaluate the Efficacy of Immunoglobulin Plus Steroid for Prevention of Coronary Artery Abnormalities in Taiwanese Refractory Kawasaki Disease (RAST Study)

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: National Taiwan University Hospital · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

Background: Kawasaki disease (KD), most popular acquired heart disease in childhood, is characterized by diffuse vasculitis, especially on the middle-sized muscular arteries. IVIG and aspirin are currently standard treatment. However, 10-15% of KD patients have poor response to such treatment and suffer from higher risk of coronary involvement. Recently, combination of prednisolone and IVIG has been shown effective to lower the chance of refractory to IVIG treatment and subsequent coronary lesions. However, no randomized trial on the steroid efficacy was ever conducted in Taiwan. Aim: Prospectively randomized open-label trial to evaluate the add-on effect of prednisolone in the refractory KD children. Methods: For the KD patients with fever persisted or relapsed 24 hours after the ending of IVIG infusion, they will be randomized into two group: IVIG group (I) and IVIG + prednisolone group (P). The KD patients in the P group will have in addition to IVIG, oral prednisolone 2mg/kg/day for at least 5 days. The difference in the response rate and percentage of coronary involvement will be compared between I and P groups. Predicted results: We plan to enroll 100 refractory KD patients, 50 patients for each group. We predict the risk of coronary involvement can be reduced from 30% to 15%.

Conditions

• Kawasaki Disease
• Steroid
• Immuoglobulin

Interventions

Type	Name	Description
DRUG	Prednisolone	Prednisolone 2mg/Kg/day for 5 days
BIOLOGICAL	immunoglobulin	immunoglobulin 2g/Kg for 12 hours

Timeline

• Start date: 2013-10-17
• Primary completion: 2020-12-31
• Completion: 2020-12-31
• First posted: 2017-06-27
• Last updated: 2017-06-27

Locations

1 site across 1 country: Taiwan