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Recombinant Human Keratinocyte Growth Factor in Unrelated and Related Transplants

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ClinicalTrials.gov Identifier: NCT00056875
Recruitment Status : Completed
First Posted : March 27, 2003
Last Update Posted : March 25, 2015
Sponsor:
Information provided by:
FDA Office of Orphan Products Development

Brief Summary:
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 or disease Intervention/treatment Phase
Graft Versus Host Disease Drug: recombinant human keratinocyte growth factor Phase 1 Phase 2

Detailed Description:
Completion date provided represents the completion date of the grant per OOPD records

Study Type : Interventional  (Clinical Trial)
Enrollment : 50 participants
Allocation: Non-Randomized
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Safety and Efficacy of Recombinant Human Keratinocyte Growth Factor in Unrelated and Related Transplants
Study Start Date : September 2002
Study Completion Date : June 2005

Resource links provided by the National Library of Medicine

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





Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 65 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
Eligible for full intensity bone marrow transplant (BMT) conditioning but who lack a 6/6 HLA idential sibling donor

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00056875


Locations
United States, Michigan
University of Michigan Cancer Center
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
Investigators
Principal Investigator: John Levine, MD Univeristy of Michigan

ClinicalTrials.gov Identifier: NCT00056875     History of Changes
Other Study ID Numbers: 2146
First Posted: March 27, 2003    Key Record Dates
Last Update Posted: March 25, 2015
Last Verified: February 2006

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