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Recombinant Human Keratinocyte Growth Factor in Unrelated and Related Transplants

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2006 by FDA Office of Orphan Products Development.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
University of Michigan
Information provided by:
FDA Office of Orphan Products Development
ClinicalTrials.gov Identifier:
NCT00056875
First received: March 25, 2003
Last updated: February 8, 2006
Last verified: February 2006
History of Changes
  Purpose

This is a single arm dose escalation study of recombinant human keratinocyte growth factor given to patients undergoing allogeneic bone marrow transplantation who are at high risk for graft versus host disease (GVHD).


Condition Intervention Phase
Graft Versus Host Disease
 Drug: recombinant human keratinocyte growth factor
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Masking: Open Label
Primary Purpose: Prevention
Official Title: Safety and Efficacy of Recombinant Human Keratinocyte Growth Factor in Unrelated and Related Transplants

Resource links provided by NLM:

Drug Information available for: Palifermin
U.S. FDA Resources

Further study details as provided by FDA Office of Orphan Products Development:

Estimated Enrollment: 50
Study Start Date: September 2002
Estimated Study Completion Date: April 2004
  Eligibility

Ages Eligible for Study:   3 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Eligible for full intensity bone marrow transplant (BMT) conditioning but who lack a 6/6 HLA idential sibling donor

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00056875

Locations
United States, Michigan
University of Michigan Cancer Center
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
FDA Office of Orphan Products Development
University of Michigan
Investigators
Principal Investigator: John Levine, MD Univeristy of Michigan
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00056875     History of Changes
Other Study ID Numbers: 2146
Study First Received: March 25, 2003
Last Updated: February 8, 2006
Health Authority: United States: Food and Drug Administration

Keywords provided by FDA Office of Orphan Products Development:
graft versus host disease
bone marrow transplant
alternative donor

Additional relevant MeSH terms:
Graft vs Host Disease
Immune System Diseases
Mitogens
 Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013