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Intra-Arterial Catheter Directed Therapy for Severe Graft vs. Host Disease (GVHD)

This study has been completed.
Sponsor:
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT00146978
First received: September 4, 2005
Last updated: November 6, 2006
Last verified: March 2006
  Purpose

Graft versus host disease (GVHD) is a major complication of allogeneic bone marrow transplantation (BMT), resulting in death in the majority of steroid resistant patients. The study was designed to assess the efficacy of regional intra-arterial treatment in patients with resistant hepatic and/or gastro-intestinal GVHD.


Condition Intervention Phase
Graft vs Host Disease
Procedure: intra-arterial treatment
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: A Phase 1/2 Study to Evaluate Intra-Arterial Catheter Directed Therapy for Severe Gastro-Intestinal and/or Hepatic Graft vs. Host Disease (GVHD)

Resource links provided by NLM:


Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • To assess the efficacy of intra-arterial Methylprednisolone treatment in decreasing the severity of acute GVHD.

Secondary Outcome Measures:
  • 1. Time to GVHD response. 2. Overall survival. 3. Disease free survival. 4. Acute toxicity.

Estimated Enrollment: 50
Study Start Date: December 2000
Estimated Study Completion Date: August 2005
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Recipient of allogeneic stem cell transplantation. AGVHD of liver and or GI tract, grade 2-4. Resistant 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. Contraindication to arterial catheterization. Has been diagnosed with multi organ failure.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00146978

Locations
Israel
Hadassah Medical Organization
Jerusalem, Israel, 91120
Sponsors and Collaborators
Hadassah Medical Organization
Investigators
Principal Investigator: Michael Y Shapira, MD Hadassah Medical Organization
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00146978     History of Changes
Other Study ID Numbers: 903/11/0-HMO-CTIL
Study First Received: September 4, 2005
Last Updated: November 6, 2006
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Additional relevant MeSH terms:
Graft vs Host Disease
Immune System Diseases

ClinicalTrials.gov processed this record on November 25, 2014