Kawasaki Disease Refractory to Initial Therapy With Intravenous Immunoglobulin
Conditions
Keywords
Infliximab, REMICADE, TA-650, intravenous immunoglobulin, Kawasaki disease, 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.
Interventions
DRUGTA-650
TA-650 at 5 mg per kg body weight on the day of TA-650 administration (day 0) is administered by intravenous infusion slowly over at least 2 hours.
DRUGPolyethylene Glycol-treated Human Immunoglobulin (VGIH)
VGIH at 2 g per kg body weight on the day of VGIH administration (day 0) is administered by intravenous infusion slowly over at least 20 hours.
Sponsors
Tanabe Pharma Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Years to 10 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Defervescence Rate Within 48 Hours After the Start of the Study Drug Administration | Up to 48hours |
Secondary
| Measure | Time frame |
|---|---|
| Duration of Fever | Up to Day56 |
| Incidence of Coronary Artery Lesions | Day 3, Day 7, Day14, Day 21, Day56 |
Countries
Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| TA-650 TA-650 at 5 mg per kg body weight on the day of TA-650 administration (day 0) is administered by intravenous infusion slowly over at least 2 hours. | 16 |
| Polyethylene Glycol-treated Human Immunoglobulin (VGIH) Polyethylene Glycol-treated Human Immunoglobulin (VGIH) at 2g per kg body weight on the day of VGIH administration (day 0) is administered by intravenous infusion slowly over at least 20 hours. | 15 |
| Total | 31 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | exacerbation of primary disease | 5 | 9 |
Baseline characteristics
| Characteristic | TA-650 | Polyethylene Glycol-treated Human Immunoglobulin (VGIH) | Total |
|---|---|---|---|
| Age, Customized >= 1 and < 2 | 2 participants | 2 participants | 4 participants |
| Age, Customized >= 2 and <= 10 | 14 participants | 13 participants | 27 participants |
| Sex: Female, Male Female | 6 Participants | 4 Participants | 10 Participants |
| Sex: Female, Male Male | 10 Participants | 11 Participants | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 15 / 16 | 15 / 15 |
| serious Total, serious adverse events | 0 / 16 | 1 / 15 |
Outcome results
Primary
Defervescence Rate Within 48 Hours After the Start of the Study Drug Administration
Time frame: Up to 48hours
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| TA-650 | Defervescence Rate Within 48 Hours After the Start of the Study Drug Administration | 75.0 percentage of patients |
| Polyethylene Glycol-treated Human Immunoglobulin (VGIH) | Defervescence Rate Within 48 Hours After the Start of the Study Drug Administration | 33.3 percentage of patients |
Secondary
Duration of Fever
Time frame: Up to Day56
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| TA-650 | Duration of Fever | Duration since starting of drug administration | 16.00 hour |
| TA-650 | Duration of Fever | Duration since completing of drug administration | 13.90 hour |
| Polyethylene Glycol-treated Human Immunoglobulin (VGIH) | Duration of Fever | Duration since starting of drug administration | 42.20 hour |
| Polyethylene Glycol-treated Human Immunoglobulin (VGIH) | Duration of Fever | Duration since completing of drug administration | 25.90 hour |
Secondary
Incidence of Coronary Artery Lesions
Time frame: Day 3, Day 7, Day14, Day 21, Day56
Population: The analysis population is evaluation patients.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TA-650 | Incidence of Coronary Artery Lesions | Day 7 | 0 percentage of patients |
| TA-650 | Incidence of Coronary Artery Lesions | Day 21 | 0 percentage of patients |
| TA-650 | Incidence of Coronary Artery Lesions | Day14 | 0 percentage of patients |
| TA-650 | Incidence of Coronary Artery Lesions | Day56 | 0 percentage of patients |
| TA-650 | Incidence of Coronary Artery Lesions | Day 3 | 0 percentage of patients |
| Polyethylene Glycol-treated Human Immunoglobulin (VGIH) | Incidence of Coronary Artery Lesions | Day56 | 0.0 percentage of patients |
| Polyethylene Glycol-treated Human Immunoglobulin (VGIH) | Incidence of Coronary Artery Lesions | Day 3 | 12.5 percentage of patients |
| Polyethylene Glycol-treated Human Immunoglobulin (VGIH) | Incidence of Coronary Artery Lesions | Day 7 | 14.3 percentage of patients |
| Polyethylene Glycol-treated Human Immunoglobulin (VGIH) | Incidence of Coronary Artery Lesions | Day14 | 16.7 percentage of patients |
| Polyethylene Glycol-treated Human Immunoglobulin (VGIH) | Incidence of Coronary Artery Lesions | Day 21 | 20.0 percentage of patients |