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Cardiovascular DiseasesPhase 2NCT00000520

Prevention of Coronary Aneurysms in Kawasaki Syndrome

A Phase 2 study testing immunoglobulins, intravenous and aspirin in people with Cardiovascular Diseases and Coronary Aneurysm, run by National Heart, Lung, and Blood Institute (NHLBI).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To test the efficacy of intravenous gamma globulin (IVGG) in preventing coronary artery aneurysms in children with Kawasaki Syndrome. Read more about this study

Who is it for?
Ages 1 year to 17 years
What is being tested?
immunoglobulins, intravenous and aspirin
Type of treatment
Injection or infusion
How many people
Not given
Where
No sites listed yet
Study dates
Jul 1985to Nov 1989
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 year to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Boys and girls who met the CDC criteria for Kawasaki Syndrome. Subjects were excluded if they presented themselves to the participating centers after the tenth day of illness.

About this study

To test the efficacy of intravenous gamma globulin (IVGG) in preventing coronary artery aneurysms in children with Kawasaki Syndrome.

Read the detailed description

BACKGROUND:

Kawasaki Syndrome is an acute febrile illness that occurs predominantly in previously healthy young children. It is of unknown etiology and was first described in Japan in 1967. The illness carries an acute mortality rate of approximately 3 percent. The Centers for Disease Control defines Kawasaki Syndrome as a fever lasting five or more days for which no explanation can be found. Patients also must have at least four of the following symptoms: bilateral conjunctival infection; infected or fissured lips, pharynx, or a 'strawberry tongue'; erythema of the palms or soles, or edema of the hands or feet, or generalized or periungual desquamation; rash; and cervical lymphadenopathy.

Coronary artery aneurysms occur in 15-20 percent of children with the illness. In the past, no treatment had been shown to be effective in preventing this complication. Investigators in Japan began to use IVGG to reduce the aneurysm formation. Preliminary results showing the usefulness of this therapy led to a multicenter trial in Japan in which 400 mg/kg/day of IVGG were given for five days to children also receiving aspirin for the condition. Results of the Japanese trial showed that within 29 days of the onset of the disease, coronary artery dilatation had developed in 42 percent of the aspirin-treated children and in 15 percent of the IVGG and aspirin-treated children.

DESIGN NARRATIVE:

Phase I was randomized, unblinded and stratified by age, sex, and center. Subjects were randomized to receive either 80 to 120 mg/kg/day of aspirin through day 14 of illness, subsequently reduced to 3 to 5 mg/kg/day as a single daily dose or to 400 mg/kg/day of intravenous gamma globulin for four consecutive days plus aspirin as above. Primary endpoint was formation of aneurysms as demonstrated by echocardiograms. Follow-up was for 7 weeks.

Phase II of the trial began enrollment of 549 patients in May 1986 and ended enrollment in November 1989. Two hundred and seventy six children were randomized to receive 400 mg/kg of intravenous gamma globulin over four consecutive days. Two hundred and seventy-three received a single infusion of 2 g/kg of body weight over 10 hours. Both treatment groups received 100 mg/kg of aspirin per day through day 14 and then 3 to 5 mg/kg per day. The primary outcome variables were the presence or absence of coronary artery abnormalities evident at the two week and seven week follow-up examinations. Echocardiograms were obtained for 523 children at the two week visit and for 520 children at the seven week visit.

Being tested
immunoglobulins, intravenous, aspirin
Medical subject headings
Cardiovascular Diseases, Coronary Aneurysm, Heart Diseases, Mucocutaneous Lymph Node Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • immunoglobulins, intravenousDrug

  • aspirinDrug

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Oct 1999 (estimated)
  2. Study startJul 1985
  3. Study completionNov 1989

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
IDs, dates and publications
ClinicalTrials.gov ID
NCT00000520
Sponsor's protocol ID
39
Other IDs
R01HL034545
Status last verified
Apr 2012
First submitted
27 Oct 1999
Last updated
13 Dec 2013
Results posted
No

Publications

  • Newburger JW, Takahashi M, Burns JC, Beiser AS, Chung KJ, Duffy CE, Glode MP, Mason WH, Reddy V, Sanders SP, et al. The treatment of Kawasaki syndrome with intravenous gamma globulin. N Engl J Med. 1986 Aug 7;315(6):341-7. doi: 10.1056/NEJM198608073150601.

    PubMed 2426590

  • Burns JC, Geha RS, Schneeberger EE, Newburger JW, Rosen FS, Glezen LS, Huang AS, Natale J, Leung DY. Polymerase activity in lymphocyte culture supernatants from patients with Kawasaki disease. Nature. 1986 Oct 30-Nov 5;323(6091):814-6. doi: 10.1038/323814a0.

    PubMed 2430187

  • Shulman ST, Rowley AH. Does Kawasaki disease have a retroviral aetiology? Lancet. 1986 Sep 6;2(8506):545-6. doi: 10.1016/s0140-6736(86)90115-7.

    PubMed 2427900

  • Leung DY, Geha RS, Newburger JW, Burns JC, Fiers W, Lapierre LA, Pober JS. Two monokines, interleukin 1 and tumor necrosis factor, render cultured vascular endothelial cells susceptible to lysis by antibodies circulating during Kawasaki syndrome. J Exp Med. 1986 Dec 1;164(6):1958-72. doi: 10.1084/jem.164.6.1958.

    PubMed 3491174

  • Burns JC, Wiggins JW Jr, Toews WH, Newburger JW, Leung DY, Wilson H, Glode MP. Clinical spectrum of Kawasaki disease in infants younger than 6 months of age. J Pediatr. 1986 Nov;109(5):759-63. doi: 10.1016/s0022-3476(86)80689-8.

    PubMed 3772656

  • Gidding SS, Shulman ST, Ilbawi M, Crussi F, Duffy CE. Mucocutaneous lymph node syndrome (Kawasaki disease): delayed aortic and mitral insufficiency secondary to active valvulitis. J Am Coll Cardiol. 1986 Apr;7(4):894-7. doi: 10.1016/s0735-1097(86)80354-0.

    PubMed 3958349

  • Hicks RV, Melish ME. Kawasaki syndrome. Pediatr Clin North Am. 1986 Oct;33(5):1151-75. doi: 10.1016/s0031-3955(16)36113-2.

    PubMed 3532006

  • Melish ME, and Hicks RV. Kawasaki Syndrome. In: John D. Nelson (editor) Current Therapy in Pediatric Infectious Disease, pp. 106-162. The C.V. Mosby Co., 1986.

  • Takahashi M, Mason W, Lewis AB. Regression of coronary aneurysms in patients with Kawasaki syndrome. Circulation. 1987 Feb;75(2):387-94. doi: 10.1161/01.cir.75.2.387.

    PubMed 3802442

  • Leung DY, Burns JC, Newburger JW, Geha RS. Reversal of lymphocyte activation in vivo in the Kawasaki syndrome by intravenous gammaglobulin. J Clin Invest. 1987 Feb;79(2):468-72. doi: 10.1172/JCI112835.

    PubMed 2433307

  • Rowley AH, Gonzalez-Crussi F, Gidding SS, Duffy CE, Shulman ST. Incomplete Kawasaki disease with coronary artery involvement. Prog Clin Biol Res. 1987;250:357-65. No abstract available.

    PubMed 3423049

  • Rowley AH, Shulman ST. The search for the etiology of Kawasaki disease. Pediatr Infect Dis J. 1987 Jun;6(6):506-8. doi: 10.1097/00006454-198706000-00002. No abstract available.

    PubMed 3302905

  • Gidding SS, Duffy CE, Pajcic S, Berdusis K, Shulman ST. Usefulness of echocardiographic evidence of pericardial effusion and mitral regurgitation during the acute stage in predicting development of coronary arterial aneurysms in the late stage of Kawasaki disease. Am J Cardiol. 1987 Jul 1;60(1):76-9. doi: 10.1016/0002-9149(87)90988-x.

    PubMed 3604947

  • Rowley AH, Shulman ST. Kawasaki disease: new etiologic clues and advances in therapy. Pediatr Dermatol. 1987 Aug;4(2):134-5. doi: 10.1111/j.1525-1470.1987.tb00767.x. No abstract available.

    PubMed 3658834

  • Rowley AH, Gonzalez-Crussi F, Gidding SS, Duffy CE, Shulman ST. Incomplete Kawasaki disease with coronary artery involvement. J Pediatr. 1987 Mar;110(3):409-13. doi: 10.1016/s0022-3476(87)80503-6.

    PubMed 3819942

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing immunoglobulins, intravenous and aspirin in people with Cardiovascular Diseases and Coronary Aneurysm, run by National Heart, Lung, and Blood Institute (NHLBI).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00000520, which also lists 22 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2013.

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