Clinical Study of TA-650 in Patients With Refractory Kawasaki Disease

• ClinicalTrials.gov Identifier: NCT01596335
• Recruitment Status: Completed
• First Posted: May 11, 2012
• Results First Posted: September 26, 2018
• Last Update Posted: October 25, 2018
• Sponsor: Mitsubishi Tanabe Pharma Corporation
• Information provided by (Responsible Party): Mitsubishi Tanabe Pharma Corporation

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Kawasaki Disease Refractory to Initial Therapy With Intravenous Immunoglobulin	Drug: TA-650; Drug: Polyethylene Glycol-treated Human Immunoglobulin (VGIH)	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 31 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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 Start Date: May 2012
• Actual Primary Completion Date: October 2014
• Actual Study Completion Date: October 2014

Arms and Interventions

Arm	Intervention/treatment
Experimental: TA-650	Drug: 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.
Active Comparator: VGIH	Drug: Polyethylene 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.

Outcome Measures

Primary Outcome Measures :

1. Defervescence Rate Within 48 Hours After the Start of the Study Drug Administration [ Time Frame: Up to 48hours ]

Secondary Outcome Measures :

1. Duration of Fever [ Time Frame: Up to Day56 ]
2. Incidence of Coronary Artery Lesions [ Time Frame: Day 3, Day 7, Day14, Day 21, Day56 ]

Eligibility Criteria

• Ages Eligible for Study: 1 Year to 10 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

Japan

Investigational site

Chubu, Japan

Investigational site

Chugoku, Japan

Investigational site

Hokkaido, Japan

Investigational site

Kanto, Japan

Investigational site

Kyushu, Japan

Investigational site

Shinetu, Japan

Investigational site

Tohoku, Japan

Investigational site

Tokai, Japan

Sponsors and Collaborators

Mitsubishi Tanabe Pharma Corporation

Investigators

• Study Director: Masaaki Mori, MD; Yokohama City University Medical Center

More Information

Publications of Results:

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.

• Responsible Party: Mitsubishi Tanabe Pharma Corporation
• ClinicalTrials.gov Identifier: NCT01596335
• Other Study ID Numbers: TA-650-22
• First Posted: May 11, 2012
• Results First Posted: September 26, 2018
• Last Update Posted: October 25, 2018
• Last Verified: September 2018

Keywords provided by Mitsubishi Tanabe Pharma Corporation:

Infliximab; REMICADE; TA-650; intravenous immunoglobulin; Kawasaki disease; IVIG

Additional relevant MeSH terms:

Mucocutaneous Lymph Node Syndrome; Vasculitis; Vascular Diseases; Cardiovascular Diseases; Lymphatic Diseases; Skin Diseases, Vascular; Skin Diseases; Immunoglobulins; Immunoglobulins, Intravenous; Antibodies; Immunologic Factors; Physiological Effects of Drugs