Mucocutaneous Lymph Node SyndromePhase 1NCT04509219
Methylprednisolone Pulse Therapy for Coronary Artery Dilatation or Aneurysm Formation in Kawasaki Disease
A Phase 1 study testing Methylprednisolone Injection in people with Mucocutaneous Lymph Node Syndrome, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Mucocutaneous Lymph Node Syndrome
- What is being tested?
- Methylprednisolone Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteTaiwan
- Study dates
- 15 Apr 2020to 31 Aug 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Kawasaki disease patients with coronary artery dilation or aneurysm formation after acute stage (at lease 3 weeks after IVIG treatment)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, 83301
Ho-Chang Kuo, MD, PhD, +886-7-7317123 ext. 8320, erickuo48@yahoo.com.tw
About this study
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.
Read the detailed description
Kawasaki disease is the most common systemic vasculitis in children. Coronary artery aneurysms may develop in 20-25% of untreated patients. Intravenous immune globulin (IVIG) can reduce coronary-artery aneurysms to 3-5%. Numerous studies and clinical trials had pointed out that corticosteroid treatment (pulse therapy or not) could lower the incidence of coronary artery abnormality in high-risk KD patients. However, the therapeutic effect of corticosteroid in KD patients with aneurysm formation after acute stage was never mentioned. There is no effective treatment for aneurysm formation available in KD after acute stage. Methylprednisolone pulse therapy (MP pulse) was used for treatment of KD during acute stage since more than 20 years ago. MP pulse plus IVIG seems not benefit for KD patients but benefit for IVIG resistant KD patients or for high-risk group of CAL formation/ IVIG resistance group. MP pulse therapy is well document used in autoimmune disease vasculitis such as SLE, rheumatoid arthritis, dermatomyosis...etc. Taking together, MP pulse is effective and safe for KD patients during acute stage. In this study, the investigators plan to use MP pulse in KD patients with CAL or aneurysm formation beyond acute stage to investigate the role of vasculitis of KD or regression of dilatation.
Methods: The investigators conducted a prospective study of methylprednisolone pulse therapy (MP pulse) for KD patients with coronary aneurysm or dilatation formation. The investigators will enroll these patients to receive methylprednisolone pulse (MP pulse, 30mg/kg, Max:1g/day for continue 3 days) for treatment. Together with other anti-inflammatory oral medicine including monteleukast, Dextromethorphan(DXM), prednisolone, and ketotifen as supplementary treatment.
The specific aim of this study is the regression of coronary artery aneurysm after MP pulse therapy.
Under the hypothesis and specific aim, the investigators plan to do in the following 3 years:
- During the 1st year, the investigators will enroll for 5-10 cases for safety surveys including blood pressure monitoring, inflammatory markers, liver function, renal function, electrolyte imbalance, growth problems as Phase I study.
- In the 2nd and 3rd year of this study, the investigators will enroll for 20-30 cases for an effective survey as Phase II study.
Results from this study will help clinicians to treat aneurysm formation or coronary artery dilatation in KD patients and reduce the activity limitation of patients, reduce the medical resource in those patients. The investigators may provide the first treatment for aneurysm in KD.
- Conditions
- Mucocutaneous Lymph Node Syndrome
- Being tested
- Methylprednisolone Injection
- Keywords
- Kawasaki Disease, aneurysm formation, coronary artery dilatation, Methylprednisolone, Pulse therapy
- Medical subject headings
- Mucocutaneous Lymph Node Syndrome, Coronary Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methylprednisolone InjectionDrug
Also called methylprednisolone pulse therapy
methylprednisolone pulse therapy, 30mg/kg, with maximal dose of 1000mg/day, for continue 3 days.
| Study group | Role | What they receive |
|---|---|---|
| Participants treated with MP pulse | Experimental | Selected participants will be given MP pulse treatment Receives: Drug: Methylprednisolone Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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 ％
Measured: 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 ％
Measured: 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 ％
Measured: 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 ％
Measured: 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 ％
Measured: 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 ％
Measured: 24 weeks from enrollment
Secondary outcomes (6)
Echocardiography on the coronary artery lesion of Kawasaki disease
Use echocardiography to measure the diameter of coronary artery (including right coronary artery [RCA], left coronary artery [LCA] and left anterior descending [LAD]) to investigate the regression of coronary artery dilatation or aneurysm formation. The dilatation is define the diameter of coronary artery. For children under 5 yrs, the diameter should not be wider than 3mm. For children over 5 yrs, the diameter should not be wider than 4mm. Adjacent segment artery should not be wider than 1.5 times.
Measured: 4 weeks from enrollment
Echocardiography on the coronary artery lesion of Kawasaki disease
Use echocardiography to measure the diameter of coronary artery (including right coronary artery [RCA], left coronary artery [LCA] and left anterior descending [LAD]) to investigate the regression of coronary artery dilatation or aneurysm formation. The dilatation is define the diameter of coronary artery. For children under 5 yrs, the diameter should not be wider than 3mm. For children over 5 yrs, the diameter should not be wider than 4mm. Adjacent segment artery should not be wider than 1.5 times.
Measured: 8 weeks from enrollment
Echocardiography on the coronary artery lesion of Kawasaki disease
Use echocardiography to measure the diameter of coronary artery (including right coronary artery [RCA], left coronary artery [LCA] and left anterior descending [LAD]) to investigate the regression of coronary artery dilatation or aneurysm formation. The dilatation is define the diameter of coronary artery. For children under 5 yrs, the diameter should not be wider than 3mm. For children over 5 yrs, the diameter should not be wider than 4mm. Adjacent segment artery should not be wider than 1.5 times.
Measured: 12 weeks from enrollment
Echocardiography on the coronary artery lesion of Kawasaki disease
Use echocardiography to measure the diameter of coronary artery (including right coronary artery [RCA], left coronary artery [LCA] and left anterior descending [LAD]) to investigate the regression of coronary artery dilatation or aneurysm formation. The dilatation is define the diameter of coronary artery. For children under 5 yrs, the diameter should not be wider than 3mm. For children over 5 yrs, the diameter should not be wider than 4mm. Adjacent segment artery should not be wider than 1.5 times.
Measured: 16 weeks from enrollment
Echocardiography on the coronary artery lesion of Kawasaki disease
Use echocardiography to measure the diameter of coronary artery (including right coronary artery [RCA], left coronary artery [LCA] and left anterior descending [LAD]) to investigate the regression of coronary artery dilatation or aneurysm formation. The dilatation is define the diameter of coronary artery. For children under 5 yrs, the diameter should not be wider than 3mm. For children over 5 yrs, the diameter should not be wider than 4mm. Adjacent segment artery should not be wider than 1.5 times.
Measured: 20 weeks from enrollment
Echocardiography on the coronary artery lesion of Kawasaki disease
Use echocardiography to measure the diameter of coronary artery (including right coronary artery [RCA], left coronary artery [LCA] and left anterior descending [LAD]) to investigate the regression of coronary artery dilatation or aneurysm formation. The dilatation is define the diameter of coronary artery. For children under 5 yrs, the diameter should not be wider than 3mm. For children over 5 yrs, the diameter should not be wider than 4mm. Adjacent segment artery should not be wider than 1.5 times.
Measured: 24 weeks from enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2020
- Study start15 Apr 2020
- Primary completion15 Apr 2021 (estimated)
- Study completion31 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mucocutaneous Lymph Node SyndromeStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- single arm, phase 1 study of methylprednisolone pulse therapy safety in treatment of aneurysm or coronary artery dilation of Kawasaki disease.
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04509219
- Sponsor's protocol ID
- MP pulse in KD
- Status last verified
- May 2020
- First submitted
- 14 Jul 2020
- Last updated
- 11 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Methylprednisolone Pulse Therapy for Coronary Artery Dilatation or Aneurysm Formation in Kawasaki Disease
- ClinicalTrials.gov ID
- NCT04509219
- Acronym / sponsor ID
- MP pulse in KD
- Conditions
- Mucocutaneous Lymph Node Syndrome
- Keywords
- Kawasaki Disease, aneurysm formation, coronary artery dilatation, Methylprednisolone, Pulse therapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 15 Apr 2020 (actual)
- Primary completion
- 15 Apr 2021 (estimated)
- Study completion
- 31 Aug 2023 (estimated)
- First posted
- 11 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Kawasaki disease is the most common systemic vasculitis in children. Coronary artery aneurysms may develop in 20-25% of untreated patients. Intravenous immune globulin (IVIG) can reduce coronary-artery aneurysms to 3-5%. Numerous studies and clinical trials had pointed out that corticosteroid treatment (pulse therapy or not) could lower the incidence of coronary artery abnormality in high-risk KD patients. However, the therapeutic effect of corticosteroid in KD patients with aneurysm formation after acute stage was never mentioned. There is no effective treatment for aneurysm formation available in KD after acute stage. Methylprednisolone pulse therapy (MP pulse) was used for treatment of KD during acute stage since more than 20 years ago. MP pulse plus IVIG seems not benefit for KD patients but benefit for IVIG resistant KD patients or for high-risk group of CAL formation/ IVIG resistance group. MP pulse therapy is well document used in autoimmune disease vasculitis such as SLE, rheumatoid arthritis, dermatomyosis...etc. Taking together, MP pulse is effective and safe for KD patients during acute stage. In this study, the investigators plan to use MP pulse in KD patients with CAL or aneurysm formation beyond acute stage to investigate the role of vasculitis of KD or regression of dilatation.
Methods: The investigators conducted a prospective study of methylprednisolone pulse therapy (MP pulse) for KD patients with coronary aneurysm or dilatation formation. The investigators will enroll these patients to receive methylprednisolone pulse (MP pulse, 30mg/kg, Max:1g/day for continue 3 days) for treatment. Together with other anti-inflammatory oral medicine including monteleukast, Dextromethorphan(DXM), prednisolone, and ketotifen as supplementary treatment.
The specific aim of this study is the regression of coronary artery aneurysm after MP pulse therapy.
Under the hypothesis and specific aim, the investigators plan to do in the following 3 years:
- During the 1st year, the investigators will enroll for 5-10 cases for safety surveys including blood pressure monitoring, inflammatory markers, liver function, renal function, electrolyte imbalance, growth problems as Phase I study.
- In the 2nd and 3rd year of this study, the investigators will enroll for 20-30 cases for an effective survey as Phase II study.
Results from this study will help clinicians to treat aneurysm formation or coronary artery dilatation in KD patients and reduce the activity limitation of patients, reduce the medical resource in those patients. The investigators may provide the first treatment for aneurysm in KD.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- single arm, phase 1 study of methylprednisolone pulse therapy safety in treatment of aneurysm or coronary artery dilation of Kawasaki disease.
| Arm | Type | Receives |
|---|---|---|
| Participants treated with MP pulse | Experimental | Drug: Methylprednisolone InjectionSelected participants will be given MP pulse treatment |
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Kawasaki disease patients with coronary artery dilation or aneurysm formation after acute stage (at lease 3 weeks after IVIG treatment)
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Methylprednisolone InjectionAlso: methylprednisolone pulse therapymethylprednisolone pulse therapy, 30mg/kg, with maximal dose of 1000mg/day, for continue 3 days. | Drug | Participants treated with MP pulse |
Primary outcome
Incidence of Treatment-Emergent Adverse Events and physical effects of Methylprednisolone pulse therapy in Kawasaki disease patients with coronary artery aneurysms
Time frame: 4 weeks from enrollment
Measurement of body weight in Kilogram
Incidence of Treatment-Emergent Adverse Events and physical effects of Methylprednisolone pulse therapy in Kawasaki disease patients with coronary artery aneurysms
Time frame: 8 weeks from enrollment
Measurement of body weight in Kilogram
Incidence of Treatment-Emergent Adverse Events and physical effects of Methylprednisolone pulse therapy in Kawasaki disease patients with coronary artery aneurysms
Time frame: 12 weeks from enrollment
Measurement of body weight in Kilogram
Incidence of Treatment-Emergent Adverse Events and physical effects of Methylprednisolone pulse therapy in Kawasaki disease patients with coronary artery aneurysms
Time frame: 16 weeks from enrollment
Measurement of body weight in Kilogram
Incidence of Treatment-Emergent Adverse Events and physical effects of Methylprednisolone pulse therapy in Kawasaki disease patients with coronary artery aneurysms
Time frame: 20 weeks from enrollment
Measurement of body weight in Kilogram
Incidence of Treatment-Emergent Adverse Events and physical effects of Methylprednisolone pulse therapy in Kawasaki disease patients with coronary artery aneurysms
Time frame: 24 weeks from enrollment
Measurement of body weight in Kilogram
Incidence of Treatment-Emergent Adverse Events and physical effects of Methylprednisolone pulse therapy in Kawasaki disease patients with coronary artery aneurysms
Time frame: 4 weeks from enrollment
Measurement of body height in centimeter
Incidence of Treatment-Emergent Adverse Events and physical effects of Methylprednisolone pulse therapy in Kawasaki disease patients with coronary artery aneurysms
Time frame: 8 weeks from enrollment
Measurement of body height in centimeter
Incidence of Treatment-Emergent Adverse Events and physical effects of Methylprednisolone pulse therapy in Kawasaki disease patients with coronary artery aneurysms
Time frame: 12 weeks from enrollment
Measurement of body height in centimeter
Incidence of Treatment-Emergent Adverse Events and physical effects of Methylprednisolone pulse therapy in Kawasaki disease patients with coronary artery aneurysms
Time frame: 16 weeks from enrollment
Measurement of body height in centimeter
Incidence of Treatment-Emergent Adverse Events and physical effects of Methylprednisolone pulse therapy in Kawasaki disease patients with coronary artery aneurysms
Time frame: 20 weeks from enrollment
Measurement of body height in centimeter
Incidence of Treatment-Emergent Adverse Events and physical effects of Methylprednisolone pulse therapy in Kawasaki disease patients with coronary artery aneurysms
Time frame: 24 weeks from enrollment
Measurement of body height in centimeter
Incidence of Treatment-Emergent Adverse Events and physical effects of Methylprednisolone pulse therapy in Kawasaki disease patients with coronary artery aneurysms
Time frame: 4 weeks from enrollment
Measurement of blood pressure \& intraocular pressure in mmHg
Incidence of Treatment-Emergent Adverse Events and physical effects of Methylprednisolone pulse therapy in Kawasaki disease patients with coronary artery aneurysms
Time frame: 8 weeks from enrollment
Measurement of blood pressure \& intraocular pressure in mmHg
Incidence of Treatment-Emergent Adverse Events and physical effects of Methylprednisolone pulse therapy in Kawasaki disease patients with coronary artery aneurysms
Time frame: 12 weeks from enrollment
Measurement of blood pressure \& intraocular pressure in mmHg
Incidence of Treatment-Emergent Adverse Events and physical effects of Methylprednisolone pulse therapy in Kawasaki disease patients with coronary artery aneurysms
Time frame: 16 weeks from enrollment
Measurement of blood pressure \& intraocular pressure in mmHg
Incidence of Treatment-Emergent Adverse Events and physical effects of Methylprednisolone pulse therapy in Kawasaki disease patients with coronary artery aneurysms
Time frame: 20 weeks from enrollment
Measurement of blood pressure \& intraocular pressure in mmHg
Incidence of Treatment-Emergent Adverse Events and physical effects of Methylprednisolone pulse therapy in Kawasaki disease patients with coronary artery aneurysms
Time frame: 24 weeks from enrollment
Measurement of blood pressure \& intraocular pressure in mmHg
Incidence of Treatment-Emergent Adverse Events and physical effects of Methylprednisolone pulse therapy in Kawasaki disease patients with coronary artery aneurysms
Time frame: 4 weeks from enrollment
Measurement of Sodium, Potassium, Chlorine level in blood in MEQ/L
Incidence of Treatment-Emergent Adverse Events and physical effects of Methylprednisolone pulse therapy in Kawasaki disease patients with coronary artery aneurysms
Time frame: 8 weeks from enrollment
Measurement of Sodium, Potassium, Chlorine level in blood in MEQ/L
Incidence of Treatment-Emergent Adverse Events and physical effects of Methylprednisolone pulse therapy in Kawasaki disease patients with coronary artery aneurysms
Time frame: 12 weeks from enrollment
Measurement of Sodium, Potassium, Chlorine level in blood in MEQ/L
Incidence of Treatment-Emergent Adverse Events and physical effects of Methylprednisolone pulse therapy in Kawasaki disease patients with coronary artery aneurysms
Time frame: 16 weeks from enrollment
Measurement of Sodium, Potassium, Chlorine level in blood in MEQ/L
Incidence of Treatment-Emergent Adverse Events and physical effects of Methylprednisolone pulse therapy in Kawasaki disease patients with coronary artery aneurysms
Time frame: 20 weeks from enrollment
Measurement of Sodium, Potassium, Chlorine level in blood in MEQ/L
Incidence of Treatment-Emergent Adverse Events and physical effects of Methylprednisolone pulse therapy in Kawasaki disease patients with coronary artery aneurysms
Time frame: 24 weeks from enrollment
Measurement of Sodium, Potassium, Chlorine level in blood in MEQ/L
Incidence of Treatment-Emergent Adverse Events and physical effects of Methylprednisolone pulse therapy in Kawasaki disease patients with coronary artery aneurysms
Time frame: 4 weeks from enrollment
Measurement of Calcium \& Fibrinogen level in blood in mg/dl
Incidence of Treatment-Emergent Adverse Events and physical effects of Methylprednisolone pulse therapy in Kawasaki disease patients with coronary artery aneurysms
Time frame: 8 weeks from enrollment
Measurement of Calcium \& Fibrinogen level in blood in mg/dl
Incidence of Treatment-Emergent Adverse Events and physical effects of Methylprednisolone pulse therapy in Kawasaki disease patients with coronary artery aneurysms
Time frame: 12 weeks from enrollment
Measurement of Calcium \& Fibrinogen level in blood in mg/dl
Incidence of Treatment-Emergent Adverse Events and physical effects of Methylprednisolone pulse therapy in Kawasaki disease patients with coronary artery aneurysms
Time frame: 16 weeks from enrollment
Measurement of Calcium \& Fibrinogen level in blood in mg/dl
Incidence of Treatment-Emergent Adverse Events and physical effects of Methylprednisolone pulse therapy in Kawasaki disease patients with coronary artery aneurysms
Time frame: 20 weeks from enrollment
Measurement of Calcium \& Fibrinogen level in blood in mg/dl
Incidence of Treatment-Emergent Adverse Events and physical effects of Methylprednisolone pulse therapy in Kawasaki disease patients with coronary artery aneurysms
Time frame: 24 weeks from enrollment
Measurement of Calcium \& Fibrinogen level in blood in mg/dl
Incidence of Treatment-Emergent Adverse Events and physical effects of Methylprednisolone pulse therapy in Kawasaki disease patients with coronary artery aneurysms
Time frame: 4 weeks from enrollment
Measurement of prothrombin time \& activated partial thromboplastin time in second
Incidence of Treatment-Emergent Adverse Events and physical effects of Methylprednisolone pulse therapy in Kawasaki disease patients with coronary artery aneurysms
Time frame: 8 weeks from enrollment
Measurement of prothrombin time \& activated partial thromboplastin time in second
Incidence of Treatment-Emergent Adverse Events and physical effects of Methylprednisolone pulse therapy in Kawasaki disease patients with coronary artery aneurysms
Time frame: 12 weeks from enrollment
Measurement of prothrombin time \& activated partial thromboplastin time in second
Incidence of Treatment-Emergent Adverse Events and physical effects of Methylprednisolone pulse therapy in Kawasaki disease patients with coronary artery aneurysms
Time frame: 16 weeks from enrollment
Measurement of prothrombin time \& activated partial thromboplastin time in second
Incidence of Treatment-Emergent Adverse Events and physical effects of Methylprednisolone pulse therapy in Kawasaki disease patients with coronary artery aneurysms
Time frame: 20 weeks from enrollment
Measurement of prothrombin time \& activated partial thromboplastin time in second
Incidence of Treatment-Emergent Adverse Events and physical effects of Methylprednisolone pulse therapy in Kawasaki disease patients with coronary artery aneurysms
Time frame: 24 weeks from enrollment
Measurement of prothrombin time \& activated partial thromboplastin time in second
Incidence of Treatment-Emergent Adverse Events and physical effects of Methylprednisolone pulse therapy in Kawasaki disease patients with coronary artery aneurysms
Time frame: 4 weeks from enrollment
Measurement of protein C \& protein S level in ％
Incidence of Treatment-Emergent Adverse Events and physical effects of Methylprednisolone pulse therapy in Kawasaki disease patients with coronary artery aneurysms
Time frame: 8 weeks from enrollment
Measurement of protein C \& protein S level in ％
Incidence of Treatment-Emergent Adverse Events and physical effects of Methylprednisolone pulse therapy in Kawasaki disease patients with coronary artery aneurysms
Time frame: 12 weeks from enrollment
Measurement of protein C \& protein S level in ％
Incidence of Treatment-Emergent Adverse Events and physical effects of Methylprednisolone pulse therapy in Kawasaki disease patients with coronary artery aneurysms
Time frame: 16 weeks from enrollment
Measurement of protein C \& protein S level in ％
Incidence of Treatment-Emergent Adverse Events and physical effects of Methylprednisolone pulse therapy in Kawasaki disease patients with coronary artery aneurysms
Time frame: 20 weeks from enrollment
Measurement of protein C \& protein S level in ％
Incidence of Treatment-Emergent Adverse Events and physical effects of Methylprednisolone pulse therapy in Kawasaki disease patients with coronary artery aneurysms
Time frame: 24 weeks from enrollment
Measurement of protein C \& protein S level in ％
6 secondary outcomes
Echocardiography on the coronary artery lesion of Kawasaki disease
Time frame: 4 weeks from enrollment
Echocardiography on the coronary artery lesion of Kawasaki disease
Time frame: 8 weeks from enrollment
Echocardiography on the coronary artery lesion of Kawasaki disease
Time frame: 12 weeks from enrollment
Echocardiography on the coronary artery lesion of Kawasaki disease
Time frame: 16 weeks from enrollment
Echocardiography on the coronary artery lesion of Kawasaki disease
Time frame: 20 weeks from enrollment
Echocardiography on the coronary artery lesion of Kawasaki disease
Time frame: 24 weeks from enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Methylprednisolone Injection in people with Mucocutaneous Lymph Node Syndrome, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ho-Chang Kuo, MD; PhD (+886-7-7317123 ext. 8320, erickuo48@yahoo.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Emergent Adverse Events and physical effects of Methylprednisolone pulse therapy in Kawasaki disease patients with coronary artery aneurysms (time frame: 4 weeks from enrollment). The study lists 42 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2020.