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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01140984
Recruitment Status : Terminated (technical issues)
First Posted : June 10, 2010
Last Update Posted : April 21, 2015
Information provided by (Responsible Party):
Hadassah Medical Organization

Brief 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.

Condition or disease Intervention/treatment Phase
Acute Graft Versus Host Disease Drug: Methylprednisolone (Intra-arterial continuous infusion of corticosteroids) Not Applicable

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.


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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Arm Intervention/treatment
Experimental: treatment 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).

Primary Outcome Measures :
  1. Hepatic response [ Time Frame: 180 days ]
    The degree to which serum bilirubin levels do or do not decrease

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Recipient of allogeneic stem cell transplantation.
  • Age>18 years.
  • Post stem cells transplant <100 days.
  • AGVHD of liver, IBMTR index B, C, D.
  • Resistant AGVHD - Patients will be eligible for inclusion if they developed grade B-D AGVHD with progression after 3 days standard treatment OR unresponsive to at least 7 days standard treatment OR incomplete response to standard treatment after 14 days.
  • Has received no 1st line treatment for steroid refractory AGVHD.
  • Signed a written informed consent

Exclusion Criteria:

  • Not fulfilling any of the inclusion criteria.
  • Active life-threatening infection.
  • Inability to comply with study requirements.
  • Inability to give informed consent.
  • Contraindication to arterial catheterization (uncorrectable coagulopathy, severe allergic reaction to contrast material or others).
  • Inability to give the first Intra-arterial treatment in less than 72h from completion of inclusion criteria
  • An IBMTR index ≤ A.
  • Refractory skin AGVHD or severe diarrhea..
  • Pregnant or breast-feeding female or childbearing potential.
  • Known to be HIV positive.
  • Has been diagnosed with veno-occlusive disease.
  • Has been diagnosed with multi organ failure.
  • Known renal failure eGFR <30

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01140984

Hadassah Medical Organisation
Jerusalem, Israel, 91120
Sponsors and Collaborators
Hadassah Medical Organization


Responsible Party: Hadassah Medical Organization Identifier: NCT01140984     History of Changes
Other Study ID Numbers: MYS-08-HMO-CTIL
First Posted: June 10, 2010    Key Record Dates
Last Update Posted: April 21, 2015
Last Verified: February 2011

Keywords provided by Hadassah Medical Organization:
acute graft versus host disease
intra arterial steroid infusion
steroid resistant acute hepatic graft versus host disease

Additional relevant MeSH terms:
Graft vs Host Disease
Immune System Diseases
Prednisolone acetate
Methylprednisolone acetate
Methylprednisolone Hemisuccinate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Neuroprotective Agents
Protective Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents