Status:
TERMINATED
Intra Arterial (IA) Steroids Infusion for Hepatic Acute Hepatic Graft Versus Host Disease (aGVHD)
Lead Sponsor:
Hadassah Medical Organization
Conditions:
Acute Graft Versus Host Disease
Eligibility:
All Genders
18+ years
Phase:
NA
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 methylpredn...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2015
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT01140984
Start Date
September 1 2010
End Date
March 1 2015
Last Update
April 21 2015
Active Locations (1)
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1
Hadassah Medical Organisation
Jerusalem, Israel, 91120