NCT04509219

Brief Summary

In this study, the investigator plan to prescribe Methylprednisolone pulse therapy in Kawasaki disease patients with coronary artery lesions or aneurysm formation beyond acute stage to investigate the role for vasculitis of KD or regression of dilatation.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Apr 2020

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 15, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 14, 2020

Completed
28 days until next milestone

First Posted

Study publicly available on registry

August 11, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2021

Completed
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2023

Completed
Last Updated

August 11, 2020

Status Verified

May 1, 2020

Enrollment Period

1 year

First QC Date

July 14, 2020

Last Update Submit

August 10, 2020

Conditions

Mucocutaneous Lymph Node Syndrome

Keywords

Kawasaki Diseaseaneurysm formationcoronary artery dilatationMethylprednisolonePulse therapy

Outcome Measures

Primary Outcomes (42)

  • Incidence of Treatment-Emergent Adverse Events and physical effects of Methylprednisolone pulse therapy in Kawasaki disease patients with coronary artery aneurysms

    Measurement of body weight in Kilogram

    4 weeks from enrollment

  • Incidence of Treatment-Emergent Adverse Events and physical effects of Methylprednisolone pulse therapy in Kawasaki disease patients with coronary artery aneurysms

    Measurement of body weight in Kilogram

    8 weeks from enrollment

  • Incidence of Treatment-Emergent Adverse Events and physical effects of Methylprednisolone pulse therapy in Kawasaki disease patients with coronary artery aneurysms

    Measurement of body weight in Kilogram

    12 weeks from enrollment

  • Incidence of Treatment-Emergent Adverse Events and physical effects of Methylprednisolone pulse therapy in Kawasaki disease patients with coronary artery aneurysms

    Measurement of body weight in Kilogram

    16 weeks from enrollment

  • Incidence of Treatment-Emergent Adverse Events and physical effects of Methylprednisolone pulse therapy in Kawasaki disease patients with coronary artery aneurysms

    Measurement of body weight in Kilogram

    20 weeks from enrollment

  • Incidence of Treatment-Emergent Adverse Events and physical effects of Methylprednisolone pulse therapy in Kawasaki disease patients with coronary artery aneurysms

    Measurement of body weight in Kilogram

    24 weeks from enrollment

  • Incidence of Treatment-Emergent Adverse Events and physical effects of Methylprednisolone pulse therapy in Kawasaki disease patients with coronary artery aneurysms

    Measurement of body height in centimeter

    4 weeks from enrollment

  • Incidence of Treatment-Emergent Adverse Events and physical effects of Methylprednisolone pulse therapy in Kawasaki disease patients with coronary artery aneurysms

    Measurement of body height in centimeter

    8 weeks from enrollment

  • Incidence of Treatment-Emergent Adverse Events and physical effects of Methylprednisolone pulse therapy in Kawasaki disease patients with coronary artery aneurysms

    Measurement of body height in centimeter

    12 weeks from enrollment

  • Incidence of Treatment-Emergent Adverse Events and physical effects of Methylprednisolone pulse therapy in Kawasaki disease patients with coronary artery aneurysms

    Measurement of body height in centimeter

    16 weeks from enrollment

  • Incidence of Treatment-Emergent Adverse Events and physical effects of Methylprednisolone pulse therapy in Kawasaki disease patients with coronary artery aneurysms

    Measurement of body height in centimeter

    20 weeks from enrollment

  • Incidence of Treatment-Emergent Adverse Events and physical effects of Methylprednisolone pulse therapy in Kawasaki disease patients with coronary artery aneurysms

    Measurement of body height in centimeter

    24 weeks from enrollment

  • Incidence of Treatment-Emergent Adverse Events and physical effects of Methylprednisolone pulse therapy in Kawasaki disease patients with coronary artery aneurysms

    Measurement of blood pressure \& intraocular pressure in mmHg

    4 weeks from enrollment

  • Incidence of Treatment-Emergent Adverse Events and physical effects of Methylprednisolone pulse therapy in Kawasaki disease patients with coronary artery aneurysms

    Measurement of blood pressure \& intraocular pressure in mmHg

    8 weeks from enrollment

  • Incidence of Treatment-Emergent Adverse Events and physical effects of Methylprednisolone pulse therapy in Kawasaki disease patients with coronary artery aneurysms

    Measurement of blood pressure \& intraocular pressure in mmHg

    12 weeks from enrollment

  • Incidence of Treatment-Emergent Adverse Events and physical effects of Methylprednisolone pulse therapy in Kawasaki disease patients with coronary artery aneurysms

    Measurement of blood pressure \& intraocular pressure in mmHg

    16 weeks from enrollment

  • Incidence of Treatment-Emergent Adverse Events and physical effects of Methylprednisolone pulse therapy in Kawasaki disease patients with coronary artery aneurysms

    Measurement of blood pressure \& intraocular pressure in mmHg

    20 weeks from enrollment

  • Incidence of Treatment-Emergent Adverse Events and physical effects of Methylprednisolone pulse therapy in Kawasaki disease patients with coronary artery aneurysms

    Measurement of blood pressure \& intraocular pressure in mmHg

    24 weeks from enrollment

  • Incidence of Treatment-Emergent Adverse Events and physical effects of Methylprednisolone pulse therapy in Kawasaki disease patients with coronary artery aneurysms

    Measurement of Sodium, Potassium, Chlorine level in blood in MEQ/L

    4 weeks from enrollment

  • Incidence of Treatment-Emergent Adverse Events and physical effects of Methylprednisolone pulse therapy in Kawasaki disease patients with coronary artery aneurysms

    Measurement of Sodium, Potassium, Chlorine level in blood in MEQ/L

    8 weeks from enrollment

  • Incidence of Treatment-Emergent Adverse Events and physical effects of Methylprednisolone pulse therapy in Kawasaki disease patients with coronary artery aneurysms

    Measurement of Sodium, Potassium, Chlorine level in blood in MEQ/L

    12 weeks from enrollment

  • Incidence of Treatment-Emergent Adverse Events and physical effects of Methylprednisolone pulse therapy in Kawasaki disease patients with coronary artery aneurysms

    Measurement of Sodium, Potassium, Chlorine level in blood in MEQ/L

    16 weeks from enrollment

  • Incidence of Treatment-Emergent Adverse Events and physical effects of Methylprednisolone pulse therapy in Kawasaki disease patients with coronary artery aneurysms

    Measurement of Sodium, Potassium, Chlorine level in blood in MEQ/L

    20 weeks from enrollment

  • Incidence of Treatment-Emergent Adverse Events and physical effects of Methylprednisolone pulse therapy in Kawasaki disease patients with coronary artery aneurysms

    Measurement of Sodium, Potassium, Chlorine level in blood in MEQ/L

    24 weeks from enrollment

  • Incidence of Treatment-Emergent Adverse Events and physical effects of Methylprednisolone pulse therapy in Kawasaki disease patients with coronary artery aneurysms

    Measurement of Calcium \& Fibrinogen level in blood in mg/dl

    4 weeks from enrollment

  • Incidence of Treatment-Emergent Adverse Events and physical effects of Methylprednisolone pulse therapy in Kawasaki disease patients with coronary artery aneurysms

    Measurement of Calcium \& Fibrinogen level in blood in mg/dl

    8 weeks from enrollment

  • Incidence of Treatment-Emergent Adverse Events and physical effects of Methylprednisolone pulse therapy in Kawasaki disease patients with coronary artery aneurysms

    Measurement of Calcium \& Fibrinogen level in blood in mg/dl

    12 weeks from enrollment

  • Incidence of Treatment-Emergent Adverse Events and physical effects of Methylprednisolone pulse therapy in Kawasaki disease patients with coronary artery aneurysms

    Measurement of Calcium \& Fibrinogen level in blood in mg/dl

    16 weeks from enrollment

  • Incidence of Treatment-Emergent Adverse Events and physical effects of Methylprednisolone pulse therapy in Kawasaki disease patients with coronary artery aneurysms

    Measurement of Calcium \& Fibrinogen level in blood in mg/dl

    20 weeks from enrollment

  • Incidence of Treatment-Emergent Adverse Events and physical effects of Methylprednisolone pulse therapy in Kawasaki disease patients with coronary artery aneurysms

    Measurement of Calcium \& Fibrinogen level in blood in mg/dl

    24 weeks from enrollment

  • Incidence of Treatment-Emergent Adverse Events and physical effects of Methylprednisolone pulse therapy in Kawasaki disease patients with coronary artery aneurysms

    Measurement of prothrombin time \& activated partial thromboplastin time in second

    4 weeks from enrollment

  • Incidence of Treatment-Emergent Adverse Events and physical effects of Methylprednisolone pulse therapy in Kawasaki disease patients with coronary artery aneurysms

    Measurement of prothrombin time \& activated partial thromboplastin time in second

    8 weeks from enrollment

  • Incidence of Treatment-Emergent Adverse Events and physical effects of Methylprednisolone pulse therapy in Kawasaki disease patients with coronary artery aneurysms

    Measurement of prothrombin time \& activated partial thromboplastin time in second

    12 weeks from enrollment

  • Incidence of Treatment-Emergent Adverse Events and physical effects of Methylprednisolone pulse therapy in Kawasaki disease patients with coronary artery aneurysms

    Measurement of prothrombin time \& activated partial thromboplastin time in second

    16 weeks from enrollment

  • Incidence of Treatment-Emergent Adverse Events and physical effects of Methylprednisolone pulse therapy in Kawasaki disease patients with coronary artery aneurysms

    Measurement of prothrombin time \& activated partial thromboplastin time in second

    20 weeks from enrollment

  • Incidence of Treatment-Emergent Adverse Events and physical effects of Methylprednisolone pulse therapy in Kawasaki disease patients with coronary artery aneurysms

    Measurement of prothrombin time \& activated partial thromboplastin time in second

    24 weeks from enrollment

  • Incidence of Treatment-Emergent Adverse Events and physical effects of Methylprednisolone pulse therapy in Kawasaki disease patients with coronary artery aneurysms

    Measurement of protein C \& protein S level in ％

    4 weeks from enrollment

  • Incidence of Treatment-Emergent Adverse Events and physical effects of Methylprednisolone pulse therapy in Kawasaki disease patients with coronary artery aneurysms

    Measurement of protein C \& protein S level in ％

    8 weeks from enrollment

  • Incidence of Treatment-Emergent Adverse Events and physical effects of Methylprednisolone pulse therapy in Kawasaki disease patients with coronary artery aneurysms

    Measurement of protein C \& protein S level in ％

    12 weeks from enrollment

  • Incidence of Treatment-Emergent Adverse Events and physical effects of Methylprednisolone pulse therapy in Kawasaki disease patients with coronary artery aneurysms

    Measurement of protein C \& protein S level in ％

    16 weeks from enrollment

  • Incidence of Treatment-Emergent Adverse Events and physical effects of Methylprednisolone pulse therapy in Kawasaki disease patients with coronary artery aneurysms

    Measurement of protein C \& protein S level in ％

    20 weeks from enrollment

  • Incidence of Treatment-Emergent Adverse Events and physical effects of Methylprednisolone pulse therapy in Kawasaki disease patients with coronary artery aneurysms

    Measurement of protein C \& protein S level in ％

    24 weeks from enrollment

Secondary Outcomes (6)

  • Echocardiography on the coronary artery lesion of Kawasaki disease

    4 weeks from enrollment

  • Echocardiography on the coronary artery lesion of Kawasaki disease

    8 weeks from enrollment

  • Echocardiography on the coronary artery lesion of Kawasaki disease

    12 weeks from enrollment

  • Echocardiography on the coronary artery lesion of Kawasaki disease

    16 weeks from enrollment

  • Echocardiography on the coronary artery lesion of Kawasaki disease

    20 weeks from enrollment

  • +1 more secondary outcomes

Study Arms (1)

Participants treated with MP pulse

EXPERIMENTAL

Selected participants will be given MP pulse treatment

Drug: Methylprednisolone Injection

Interventions

Methylprednisolone InjectionDRUG

methylprednisolone pulse therapy, 30mg/kg, with maximal dose of 1000mg/day, for continue 3 days.

Also known as: methylprednisolone pulse therapy
Participants treated with MP pulse

Eligibility Criteria

AgeUp to 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Kawasaki disease patients with coronary artery dilation or aneurysm formation after acute stage (at lease 3 weeks after IVIG treatment)

You may not qualify if:

  • patients meet the contraindications of Methylprednisolone sodium succinate, e.g., allergic to Methylprednisolone sodium succinate, premature infant, immune system related thrombocytopathy, immunodeficiency, any congenital diseases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, 83301, Taiwan

RECRUITING

MeSH Terms

Conditions

Mucocutaneous Lymph Node SyndromeCoronary Aneurysm

Interventions

Methylprednisolone

Condition Hierarchy (Ancestors)

VasculitisVascular DiseasesCardiovascular DiseasesLymphatic DiseasesHemic and Lymphatic DiseasesSkin Diseases, VascularSkin DiseasesSkin and Connective Tissue DiseasesCoronary DiseaseMyocardial IschemiaHeart DiseasesAneurysm

Intervention Hierarchy (Ancestors)

PrednisolonePregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Central Study Contacts

Ho-Chang Kuo, MD; PhD

CONTACT

+886-7-7317123erickuo48@yahoo.com.tw

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: single arm, phase 1 study of methylprednisolone pulse therapy safety in treatment of aneurysm or coronary artery dilation of Kawasaki disease.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 14, 2020

First Posted

August 11, 2020

Study Start

April 15, 2020

Primary Completion

April 15, 2021

Study Completion

August 31, 2023

Last Updated

August 11, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)