Recombinant Human Keratinocyte Growth Factor in Unrelated and Related Transplants - Tabular View

Tracking Information

First Received Date ^ICMJE

March 25, 2003

Last Updated Date

February 8, 2006

Start Date ^ICMJE

September 2002

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00056875 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Recombinant Human Keratinocyte Growth Factor in Unrelated and Related Transplants

Official Title ^ICMJE

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

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).

Detailed Description

Study Phase

Phase I, Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Prevention, Non-Randomized, Open Label, Historical Control, Safety/Efficacy Study

Condition ^ICMJE

Graft Versus Host Disease

Intervention ^ICMJE

Drug: recombinant human keratinocyte growth factor

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

Completion Date

April 2004

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

3 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00056875

Responsible Party

Study ID Numbers ^ICMJE

2146

Study Sponsor ^ICMJE

FDA Office of Orphan Products Development

Collaborators ^ICMJE

University of Michigan

Investigators ^ICMJE

Principal Investigator:

John Levine, MD

Univeristy of Michigan

Information Provided By

FDA Office of Orphan Products Development

Verification Date

February 2006

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP