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Kawasaki Disease clinical trials

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NCT ID: NCT02951234 Recruiting - Kawasaki Disease Clinical Trials

A Multi-center, Randomized to Compare the Efficacy of IVIG Alone and IVIG Plus High-dose Aspirin in Kawasaki Disease

Start date: September 2016
Phase: N/A
Study type: Interventional

Kawasaki disease (KD) is an acute febrile systemic vasculitis most commonly seen in children under the age of 5 years old. This trial has been designed as a multi-center, prospective, randomized controlled, evaluator-blinded trial with two parallel groups to determine whether IVIG alone as the primary therapy in acute-stage KD is as effective as IVIG combined with high-dose aspirin therapy. The primary endpoint is defined as CAL formation at 6-8 weeks.

NCT ID: NCT02853266 Active, not recruiting - Kawasaki Disease Clinical Trials

Measurement of Antibodies in Adults With a History of Kawasaki Disease

KAWASAKI Ac
Start date: September 2011
Phase: N/A
Study type: Observational

Kawasaki disease (KD) is an acute systemic vasculitic syndrome with coronary tropism. It has been reported worldwide, but it is ten times more common in Asian population. It is the second vasculitis of the child by its frequency after rheumatoid purpura. It occurs in 80% of cases between 1 and 5 years, with a maximal incidence around the age of 12 months. KD is not well understood and the cause is yet unknown. It may be an autoimmune disorder. The problem affects the mucous membranes, lymph nodes, walls of the blood vessels, and the heart.The clinical picture of KD associate a persistent fever and an antipyretics resistance with mucocutaneous signs and bulky cervical lymphadenopathy usually unilateral. There is currently no vaccine available against Kawasaki disease so it is extremely important to be able to recognize symptoms before they set in and become too severe. Chagas disease (CD) is caused by the parasite Trypanosoma cruzi. Acute CD occurs immediately after infection, may last up to a few weeks or months. Infection may be mild or asymptomatic. There may be fever or swelling around the site of inoculation, and acute infection may result in severe inflammation of the heart muscle. The notion that the pathology of CD has an autoimmune component was initially based on the finding of circulating antibodies binding heart tissue antigens in patients chronically infected with T. cruzi. A recent study reports a possible antigen (non-cruzi-related antibody NCRA) mimicry characterized by a serological reactivity to a well-defined T. cruzi antigen in blood samples from individuals not exposed to the parasite. The measured seroprevalence of such cross-reactivity is in favor of a highly prevalent immunogen acquired in childhood. There are similarities in mechanism of CD and KD: it could be interesting to explore the presence of NCRA in blood samples from adults with a history of KD. The objective of the study is the measurement of the biomarker NCRA in serum in adults with a history of KD compare to a control population. This measurement and the prevalence may permit to associate the NCRA to a possible pathogenic agent.

NCT ID: NCT02771288 Recruiting - Kawasaki Disease Clinical Trials

Safety and Vascular Remodelling After BVS Implantation for Stenotic or Occluded Lesions in Children and Young Adults With KD.

Start date: February 2016
Phase: N/A
Study type: Interventional

To investigate the safety and long-term vascular remodeling after bioresorbable vascular scaffold (BVS) implantation for stenotic or occluded lesion in children or young adults with Kawasaki disease (KD). Background: KD occurs worldwide, most prevalent in Japan and East Asian countries. Coronary artery lesion is the predominant determinant of KD outcome in the long-term. Children with KD with aneurysms at least 6 mm in maximal diameter had a greater than 50% chance of developing a clinically significant stenotic lesion during follow-up. They are at risk of myocardial infarction-related sudden death or congestive heart failure as young adults. Bypass surgery could be the reasonable strategy but the long-term patency of the graft remains unsatisfactory. Percutaneous angioplasty with drug-eluting stents (DES) implantation is the alternative. However, metallic stenting remains problematic in several aspects mainly due to the restriction of vessel expansive remodeling. The novel BVS has the potential to be free from the limitation due to scaffold degradation.

NCT ID: NCT02439996 Completed - Kawasaki Disease Clinical Trials

Different Doses of IVIG for Kawasaki Disease

Start date: January 2014
Phase: Phase 3
Study type: Interventional

The objective of this study is to investigate the effect of different doses of intravenous immunoglobulin (IVIG) (1g/kg once, 1g/kg twice, 2g/kg once) for Kawasaki disease (KD) in a multicentre, prospective,randomised trial.

NCT ID: NCT02390596 Completed - Children Clinical Trials

Anakinra and Kawasaki Disease

KAWAKINRA
Start date: February 5, 2016
Phase: Phase 2
Study type: Interventional

The study is designed to assess the efficacy and safety of anakinra, an interleukin 1 receptor antagonist, in patients with Kawasaki disease who failed to respond to standard treatment:e.g. one infusion of 2g/kg of intravenous immunoglobulins.

NCT ID: NCT02359643 Enrolling by invitation - Kawasaki Disease Clinical Trials

Multi-center Prospective Randomized Control Trail of High Dose Aspirin in Acute Stage of Kawasaki Disease

Start date: May 2013
Phase: N/A
Study type: Interventional

Kawasaki disease (KD) is an acute multi-system vasculitis syndrome of unknown etiology occurring mostly in infants and children younger than 5 years of age. In developed countries, it is the leading cause of acquired heart disease in children. However, KD remains a mysterious disease. Single high dose intravenous immunoglobulin (IVIG, 2gm/kg) and aspirin are standard treatment for KD. Aspirin have been prescribed in treatment of KD for decade even earlier than usage of IVIG. High dose aspirin mainly act as anti-inflammation, while low dose aspirin as anti-platelet. IVIG may play most of the role of anti-inflammation in acute stage of KD. Hsieh et al. reported that KD without high dose aspirin had the same treatment response after IVIG. Therefore it is still unclear about the necessarily of high dose aspirin in acute stage of KD. This study was conduct to investigate the role of high dose aspirin in acute stage of KD via a multi-center randomized control trail, and we plan to achieve the followings till year 2017: 1. Enroll 300 KD patients from multiple medical centers . Randomize group patients as group 1: with high dose aspirin (more than 30/mg/kd/day) until fever subsided and shift to low dose aspirin (3-5mg/kg/day, N=150); and group 2: without high dose aspirin during acute febrile stage, only use low dose aspirin (N=150). 2. Compare data including fever days, admission duration, laboratory data (CBC/DC, GOT/GPT, BUN/Cr, Alb, ESR, CRP, 2D echo), IVIG treatment response and CAL formation rate (followed at least 1 year).

NCT ID: NCT02317913 Completed - Kawasaki Disease Clinical Trials

Epidemiologic Features of Kawasaki Disease in Shanghai From 2008 Through 2012

Start date: April 2013
Phase: N/A
Study type: Observational

To investigate the epidemiological pictures of Kawasaki disease (KD) in Shanghai from 2008 through 2012, and illustrate the risk factors of coronary arterial lesions .

NCT ID: NCT02298062 Completed - Kawasaki Disease Clinical Trials

Infliximab for Kawasaki Disease Patients Resistant to IVIG : a Multicentre, Prospective, Randomised Trial

Start date: January 2013
Phase: Phase 3
Study type: Interventional

The objective of this study is to investigate the effect of infliximab to the children who don't respond to the first dose of intravenous immunoglobulin (IVIG) (2g/kg) in Kawasaki disease.

NCT ID: NCT02179853 Completed - Kawasaki Disease Clinical Trials

Anakinra in Infants and Children With Coronary Artery Abnormalities in Acute Kawasaki Disease

Start date: November 2014
Phase: Phase 1/Phase 2
Study type: Interventional

Kawasaki disease (KD) is the leading cause of acquired heart disease in children in the developed world. Despite available treatment, 25% of children in San Diego County appropriately treated for KD develop coronary artery abnormalities that may lead to complications later in life, including heart attack. Although the investigators can identify children with KD that have these coronary artery abnormalities, there is no approved additional treatment to decrease coronary artery inflammation and arrest or prevent damage to the coronary arteries. Anakinra, a therapy that blocks the high levels of interleukin 1 (IL1) that lead to inflammation during acute KD, has been shown in the KD mouse model to prevent the development of coronary artery damage. Therefore, the investigators propose to study the safety and activity of anakinra in infants and children < 2 years old with coronary artery abnormalities from KD.

NCT ID: NCT02176070 Completed - Clinical trials for Giant Cell Arteritis

Reproductive Health in Men and Women With Vasculitis

Start date: February 2011
Phase: N/A
Study type: Observational [Patient Registry]

The purpose of this study is to learn about reproductive health, including fertility and pregnancies, in people with vasculitis.