NCT02322151 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Kaida K, Ikegame K, Fujioka T, Taniguchi Y, Inoue T, Hasei H, Tamaki H, Yoshihara S, Kawase I, Ogawa H
Kinetics of granulocyte colony-stimulating factor in the human milk of a nursing donor receiving treatment for mobilization of the peripheral blood stem cells. Acta Haematol. 2007;118(3):176-7. Epub 2007 Oct 3.
Pessach I, Shimoni A, Nagler A
Granulocyte-colony stimulating factor for hematopoietic stem cell donation from healthy female donors during pregnancy and lactation: what do we know? Hum Reprod Update. 2013 May-Jun;19(3):259-67. doi: 10.1093/humupd/dms053. Epub 2013 Jan 3. Review.
Shibata H, Yamane T, Aoyama Y, Nakamae H, Hasegawa T, Sakamoto C, Terada Y, Koh G, Hino M
Excretion of granulocyte colony-stimulating factor into human breast milk. Acta Haematol. 2003;110(4):200-1.

Pharmacokinetics of Granulocyte Colony Stimulating Factor in the Breast Milk of Volunteer Peripheral Blood Stem Cell Donor

Clinical trial NCT02322151 - References