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An Investigator Initiated Open Study to Evaluate the Efficacy and Safety of Intra Arterial Infusion for Treatment of Steroid Resistant Acute Hepatic Graft Versus Host Disease (AGVHD)
Post allogeneic hematopoietic stem cell transplantation (HSCT) patients with steroid resistant acute GVHD localised to the liver will receive 24 hours continuous intra-arterial infusion of methylprednisolone.
The study population will include 30 patients with SR AGVHD having an index of B, C, or D on the IBMTR severity index localized to the liver. Standard treatment for SR AGVHD includes: IV cyclosporine or tacrolimus with adjusted doses depending on serum levels and methylprednisolone or prednisone 2 mg/kg/d. This treatment may be continued during the study period although steroid taper down should be attempted if clinically possible. GVHD diagnosis will be based upon clinical criteria and biopsy (if needed) from an involved organ. GVHD will be graded according to the International Bone Marrow Transplantation Registry (IBMTR) severity index. Intra-arterial treatment should be given in less than 72h from completion of inclusion criteria. Partially responding or non-responding patients may receive a second treatment within 14 days of the initial intra-arterial treatment, at the discretion of the treating physician. Definitions Hepatic response: * Initial response - the day in which bilirubin level began to decrease. * Partial response 75 - the day in which bilirubin level decreased below 75% of basal level. * Partial response 50 - the day in which bilirubin level decreased below 50% of basal level. * Partial response 25 - the day in which bilirubin level decreased below 25% of basal level. * Complete response - the day in which bilirubin level decreased to normal level.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Hadassah Medical Organisation
Jerusalem, Israel
Start Date
September 1, 2010
Primary Completion Date
March 1, 2015
Completion Date
March 1, 2015
Last Updated
April 21, 2015
2
ACTUAL participants
Methylprednisolone (Intra-arterial continuous infusion of corticosteroids)
DRUG
Lead Sponsor
Hadassah Medical Organization
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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View ClinicalTrials.gov Terms and ConditionsNCT06480630