Overview

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

Status:
Terminated
Trial end date:
2015-03-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Hadassah Medical Organization
Treatments:
Methylprednisolone
Methylprednisolone Acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Criteria
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