Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
University of Michigan
Information provided by:
FDA Office of Orphan Products Development Identifier:
First received: March 25, 2003
Last updated: February 8, 2006
Last verified: February 2006

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:

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

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

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

  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 identifier: NCT00056875

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

No publications provided 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
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions processed this record on March 03, 2015