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
Recruitment status was Active, not recruiting
Sponsor:
Collaborator:
University of Michigan
Information provided by:
FDA Office of Orphan Products Development
ClinicalTrials.gov Identifier:
NCT00056875
First received: March 25, 2003
Last updated: February 8, 2006
Last verified: February 2006
| Tracking Information | |||||
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| First Received Date ICMJE | March 25, 2003 | ||||
| Last Updated Date | February 8, 2006 | ||||
| Start Date ICMJE | September 2002 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT00056875 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| 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 | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 1 Phase 2 |
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| Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Masking: Open Label Primary Purpose: Prevention |
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| Condition ICMJE | Graft Versus Host Disease | ||||
| Intervention ICMJE | Drug: recombinant human keratinocyte growth factor | ||||
| Study Arm (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Enrollment ICMJE | 50 | ||||
| Completion Date | April 2004 | ||||
| Primary Completion Date | Not Provided | ||||
| 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 Number ICMJE | NCT00056875 | ||||
| Other Study ID Numbers ICMJE | 2146 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Not Provided | ||||
| 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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