Recombinant Human Keratinocyte Growth Factor in Unrelated and Related Transplants

Graft Versus Host Disease Clinical Trial

Official title:

Safety and Efficacy of Recombinant Human Keratinocyte Growth Factor in Unrelated and Related Transplants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00056875
• Other study ID #: 2146
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: March 25, 2003
• Last updated: March 24, 2015
• Start date: September 2002
• Est. completion date: June 2005

Study information

• Verified date: February 2006
• Source: FDA Office of Orphan Products Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Description:

Completion date provided represents the completion date of the grant per OOPD records

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: June 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Years to 65 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Graft Versus Host Disease
• Graft vs Host Disease

Intervention

Drug:
• recombinant human keratinocyte growth factor

Locations

Country	Name	City	State
United States	University of Michigan Cancer Center	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States,