NCT01140984

Intra Arterial (IA) Steroids Infusion for Hepatic Acute Hepatic Graft Versus Host Disease (aGVHD)

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)

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Hadassah Medical Organization · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Acute Graft Versus Host Disease

Interventions

Type	Name	Description
DRUG	Methylprednisolone (Intra-arterial continuous infusion of corticosteroids)	Sedation/anesthesia of patient followed by placement of a 4F vascular sheath and a diagnostic and hepatic angiogram. Angiographic catheter tip to be placed in the proximal proper hepatic artery, secured in place externally and connected to an arterial line pressurized system which allows continuous drip infusion of methylprednisolone diluted in normal saline (600mg/m2 with maximal total dose of 100mg diluted in 480cc in normal saline administered at 20cc/hr for 24 hours).

Timeline

• Start date: 2010-09-01
• Primary completion: 2015-03-01
• Completion: 2015-03-01
• First posted: 2010-06-10
• Last updated: 2015-04-21

Locations

1 site across 1 country: Israel