Clinical Trial Results:
An open label, randomized, active controlled, dose finding study to evaluate the pharmacodynamics, pharmacokinetics, efficacy and safety of balugrastim at doses of 300 μg/kg and 670 μg/kg in pediatric patients diagnosed with solid tumors receiving chemotherapy.
Summary
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EudraCT number |
2012-005432-28 |
Trial protocol |
HU CZ BG SK |
Global completion date |
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Paediatric regulatory details
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Is the trial part of an agreed EMA paediatric investigation plan? |
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Is the trial in scope of article 45 of Regulation (EC) No 1901/2006? |
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Is the trial in scope of article 46 of Regulation (EC) No 1901/2006? |
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Results information
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Results version number |
v1(current) |
This version publication date |
21 Aug 2021
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First version publication date |
21 Aug 2021
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Other versions |
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Summary report(s) |
NEUGR-005 Withdrawn Study Statement |
Note: The legislation allows summary attachments to be posted instead of the full dataset for this trial. Refer to Commission Guideline 2012/C 302/03
for further information.