Clinical trial NCT01596335: Clinical Study of TA-650 in Patients With Refractory Kawasaki Disease
Official title: 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).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Kawasaki Disease Refractory to Initial Therapy With Intravenous Immunoglobulin
Keywords: Infliximab
REMICADE
TA-650
intravenous immunoglobulin
Kawasaki disease
IVIG
Lead sponsor: Mitsubishi Tanabe Pharma Corporation
Sponsor class: INDUSTRY
First posted: 2012-05-11
Enrollment: 31
Sex: ALL
Minimum age (years): 1
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Defervescence Rate Within 48 Hours After the Start of the Study Drug Administration
timeFrame: Up to 48hours
Secondary outcomes:
measure: Duration of Fever
timeFrame: Up to Day56
measure: Incidence of Coronary Artery Lesions
timeFrame: Day 3, Day 7, Day14, Day 21, Day56
Other outcomes:
Locations:
city: Chubu
country: Japan
facility: Investigational site
city: Chugoku
country: Japan
facility: Investigational site
city: Hokkaido
country: Japan
facility: Investigational site
city: Kanto
country: Japan
facility: Investigational site
city: Kyushu
country: Japan
facility: Investigational site
city: Shinetu
country: Japan
facility: Investigational site
city: Tohoku
country: Japan
facility: Investigational site
city: Tokai
country: Japan
facility: Investigational site
Study officials:
affiliation: Yokohama City University Medical Center
name: Masaaki Mori, MD
role: STUDY_DIRECTOR
References:
citation: Mori M, Hara T, Kikuchi M, Shimizu H, Miyamoto T, Iwashima S, Oonishi T, Hashimoto K, Kobayashi N, Waki K, Suzuki Y, Otsubo Y, Yamada H, Ishikawa C, Kato T, Fuse S. Infliximab versus intravenous immunoglobulin for refractory Kawasaki disease: a phase 3, randomized, open-label, active-controlled, parallel-group, multicenter trial. Sci Rep. 2018 Jan 31;8(1):1994. doi: 10.1038/s41598-017-18387-7.