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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00004787 |
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Date of registration:
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24/02/2000 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Phase II Pilot Study of Granulocyte Colony-Stimulating Factor for Inherited Bone Marrow Failure Syndromes
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Scientific title:
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Date of first enrolment:
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December 1994 |
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Target sample size:
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20 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00004787 |
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Study type:
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Interventional |
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Study design:
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Primary Purpose: Treatment
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Phase:
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Phase 2
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Contacts
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Name:
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David A. Williams |
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Address:
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Telephone:
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Email:
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Affiliation:
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James Whitcomb Riley Hospital for Children |
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Key inclusion & exclusion criteria
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PROTOCOL ENTRY CRITERIA:
--Disease Characteristics--
Inherited bone marrow failure syndrome, including:
- Fanconi's anemia
- Dyskeratosis congenita
- Shwachman syndrome
- Amegakaryocytic thrombocytopenia
- Decreased megakaryocytes in infancy
- No thrombocytopenia with absent radius syndrome (TAR)
- No trisomy 13 or 18
- No clonal bone marrow karyotype
--Prior/Concurrent Therapy--
- At least 4 weeks since growth factors
- Concurrent therapy allowed if not altered for 30 days prior to entry through week 8
- No concurrent investigational drugs
--Patient Characteristics--
- Hematopoietic: ANC <1000
- No leukemia
- Other: No medical or psychiatric contraindication to protocol participation
- No pregnant or nursing women
Age minimum:
N/A
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Fanconi's Anemia
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Dyskeratosis Congenita
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Thrombocytopenia
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Shwachman Syndrome
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Intervention(s)
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Drug: filgrastim
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Secondary ID(s)
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199/11877
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UTMB-416
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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