Intra Arterial (IA) Steroids Infusion for Hepatic Acute Hepatic Graft Versus Host Disease (aGVHD)
|ClinicalTrials.gov Identifier: NCT01140984|
Recruitment Status : Terminated (technical issues)
First Posted : June 10, 2010
Last Update Posted : April 21, 2015
|Condition or disease||Intervention/treatment||Phase|
|Acute Graft Versus Host Disease||Drug: Methylprednisolone (Intra-arterial continuous infusion of corticosteroids)||Not Applicable|
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.
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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)|
|Study Start Date :||September 2010|
|Actual Primary Completion Date :||March 2015|
|Actual Study Completion Date :||March 2015|
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).
- Hepatic response [ Time Frame: 180 days ]The degree to which serum bilirubin levels do or do not decrease
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01140984
|Hadassah Medical Organisation|
|Jerusalem, Israel, 91120|