Kawasaki Disease Refractory to Initial Therapy With Intravenous Immunoglobulin Clinical Trial
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).
| NCT number | NCT01596335 |
| Other study ID # | TA-650-22 |
| Secondary ID | |
| Status | Completed |
| Phase | Phase 3 |
| First received | |
| Last updated | |
| Start date | May 2012 |
| Est. completion date | October 2014 |
| Verified date | September 2018 |
| Source | Mitsubishi Tanabe Pharma Corporation |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 31 |
| Est. completion date | October 2014 |
| Est. primary completion date | October 2014 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 1 Year to 10 Years |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| 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 |
| Lead Sponsor | Collaborator |
|---|---|
| Mitsubishi Tanabe Pharma Corporation |
Japan,
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, r — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Defervescence Rate Within 48 Hours After the Start of the Study Drug Administration | Up to 48hours | ||
| Secondary | Duration of Fever | Up to Day56 | ||
| Secondary | Incidence of Coronary Artery Lesions | Day 3, Day 7, Day14, Day 21, Day56 |