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Trial record 7 of 9 for:    Recruiting, Not yet recruiting, Available Studies | "Mucocutaneous Lymph Node Syndrome"

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

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ClinicalTrials.gov Identifier: NCT03200561
Recruitment Status : Recruiting
First Posted : June 27, 2017
Last Update Posted : June 27, 2017
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

Brief 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%.


Condition or disease Intervention/treatment Phase
Kawasaki Disease Steroid Immuoglobulin Drug: Prednisolone Biological: immunoglobulin Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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)
Actual Study Start Date : October 17, 2013
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kawasaki Disease

Arm Intervention/treatment
Active Comparator: S group
IVIG (2g/Kg in 12 hours)+oral prednisolone (2mg/Kg/day for 5 days)
Drug: Prednisolone
Prednisolone 2mg/Kg/day for 5 days

Biological: immunoglobulin
immunoglobulin 2g/Kg for 12 hours

Placebo Comparator: I group
IVIG (2g/Kg in 12 hours)
Biological: immunoglobulin
immunoglobulin 2g/Kg for 12 hours




Primary Outcome Measures :
  1. maximal coronary z score [ Time Frame: one month ]
    echocardiography


Secondary Outcome Measures :
  1. fever more than 38 degree [ Time Frame: 3 days ]
    from end of second course of IVIG



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • KD (Kawasaki disease) patients who failed to respond to the initial IVIG as those who had persistent fever that lasted for more than 24 hours (nonresponse to the initial IVIG) or recrudescent fever associated with KD symptoms after an afebrile period (relapse).

Exclusion Criteria:

  • KD patients, those diagnosed on or after day 9 of illness (the first illness day was defined as the day of fever onset), those with coronary artery abnormalities before enrolment, those who were afebrile before enrolment, those who had received steroids (oral, intravenous, intramuscular, or subcutaneous) in the 30 days before the study or intravenous immunoglobulin in the previous 180 days, those with concomitant severe medical disorders (eg, immunodeficiency, chromosomal anomalies, congenital heart diseases, metabolic diseases, nephritis, collagen diseases), and those with suspected infectious disease, including sepsis, septic meningitis, peritonitis, bacterial pneumonia, varicella, and influenza.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03200561


Contacts
Contact: Ming-Tai Lin, MD, PhD 886-2-23123456 ext 71734 mingtailin@ntu.edu.tw

Locations
Taiwan
China Medical University Hospital Recruiting
Taichung, Taiwan, 400
Contact: Jeng-Sheng Chang, MD    886-4-22052121 ext 4646    d0669@mail.cmuh.org.tw   
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Ming-Tai Lin, MD, PhD National Taiwan University Hospital, Taipei, Taiwan
Study Director: Mei-Hwan Wu, MD, PhD National Taiwan University Hospital, Taipei, Taiwan

Study Data/Documents: Clinical trial approval  This link exits the ClinicalTrials.gov site
Identifier: 201308036MIND

Publications:
Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT03200561     History of Changes
Other Study ID Numbers: 201308036MIND
First Posted: June 27, 2017    Key Record Dates
Last Update Posted: June 27, 2017
Last Verified: June 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Mucocutaneous Lymph Node Syndrome
Vasculitis
Vascular Diseases
Cardiovascular Diseases
Lymphatic Diseases
Skin Diseases, Vascular
Skin Diseases
Prednisolone acetate
Methylprednisolone acetate
Prednisolone
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone hemisuccinate
Prednisolone phosphate
Immunoglobulins
Antibodies
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Neuroprotective Agents
Protective Agents
Immunologic Factors