Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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:
Information provided by (Responsible Party):
Mitsubishi Tanabe Pharma Corporation

Tracking Information
First Submitted Date  ICMJE May 9, 2012
First Posted Date  ICMJE May 11, 2012
Results First Submitted Date  ICMJE January 23, 2018
Results First Posted Date  ICMJE September 26, 2018
Last Update Posted Date October 25, 2018
Study Start Date  ICMJE May 2012
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 10, 2012)
Defervescence Rate Within 48 Hours After the Start of the Study Drug Administration [ Time Frame: Up to 48hours ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01596335 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 10, 2012)
  • Duration of Fever [ Time Frame: Up to Day56 ]
  • Incidence of Coronary Artery Lesions [ Time Frame: Day 3, Day 7, Day14, Day 21, Day56 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Study of TA-650 in Patients With Refractory Kawasaki Disease
Official Title  ICMJE 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).
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Kawasaki Disease Refractory to Initial Therapy With Intravenous Immunoglobulin
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • Experimental: TA-650
    Intervention: Drug: TA-650
  • Active Comparator: VGIH
    Intervention: Drug: Polyethylene Glycol-treated Human Immunoglobulin (VGIH)
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 9, 2015)
31
Original Estimated Enrollment  ICMJE
 (submitted: May 10, 2012)
100
Actual Study Completion Date  ICMJE October 2014
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 1 Year to 10 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01596335
Other Study ID Numbers  ICMJE TA-650-22
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Mitsubishi Tanabe Pharma Corporation
Study Sponsor  ICMJE Mitsubishi Tanabe Pharma Corporation
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Masaaki Mori, MD Yokohama City University Medical Center
PRS Account Mitsubishi Tanabe Pharma Corporation
Verification Date September 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP