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| 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). |
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| 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 * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Enrollment ICMJE | 50 | ||||
| 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 |
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| Gender | Both | ||||
| Ages | 3 Years to 65 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| 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 |
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| Information Provided By | FDA Office of Orphan Products Development | ||||
| Verification Date | February 2006 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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