Study title: A Phase III multicenter, double blind, randomized, parallel-group, vehicle controlled study to evaluate the safety and efficacy of 5µg/kg/day recombinant Granulocyte Colony Stimulating Factor (rHuG-CSF) in the treatment of patients who have undergone bone marrow transplantation (BMT).
Type of medicine: Medicines containing chemical active substances | |||||
Therapeutic area: Hemic and Lymphatic Diseases [C15] | |||||
Brands: Please see report | |||||
MAH holders: Please see report | |||||
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Active substance: LENOGRASTIM | |||||
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Study number: GHBA-269 | |||||
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Scope of study: Clinical | |||||
Population of study subjects: | Preterm newborn Infants | Newborn infants (1 to 27 days) | Infants and toddlers (28 days to 24 months) | Children (2 to 11 years) | Adolescents (12 to 18 years) |
- | - | - | Y | Y |