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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2011 by Hadassah Medical Organization
Sponsor:
Information provided by (Responsible Party):
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT01140984
First received: June 9, 2010
Last updated: June 16, 2013
Last verified: February 2011

June 9, 2010
June 16, 2013
September 2010
December 2015   (final data collection date for primary outcome measure)
Hepatic response [ Time Frame: 180 days ] [ Designated as safety issue: No ]
The degree to which serum bilirubin levels do or do not decrease
Same as current
Complete list of historical versions of study NCT01140984 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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)

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.
Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Acute Graft Versus Host Disease
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).
Experimental: treatment
Intervention: Drug: Methylprednisolone (Intra-arterial continuous infusion of corticosteroids)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
February 2016
December 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Michael Y Shapira, MD 00 972 2 6778357 shapiram@hadassah.org.il
Contact: Allan Bloom, MD FSIR 00 972 2 6776502 allan@hadassah.org.il
Israel
 
NCT01140984
MYS-08-HMO-CTIL
No
Hadassah Medical Organization
Hadassah Medical Organization
Not Provided
Not Provided
Hadassah Medical Organization
February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP