NCT00067054 - 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)

Braine HG, Elfenbein GJ, Mellits ED
Peripheral blood lymphocyte numbers, lymphocyte proliferative responses in vitro, and serum immunoglobulins in regular hemapheresis donors. J Clin Apher. 1985;2(3):213-8. doi: 10.1002/jca.2920020302.
Heal JM, Horan PK, Schmitt TC, Bailey G, Nusbacher J
Long-term follow-up of donors cytapheresed more than 50 times. Vox Sang. 1983;45(1):14-24. doi: 10.1111/j.1423-0410.1983.tb04118.x.
Strauss RG, Maguire LC, Koepke JA, Thompson JS
Effect of intermittent-flow centrifugation leukapheresis on donor leukocyte counts. Acta Haematol. 1980;63(3):128-31. doi: 10.1159/000207383.

VRC 200: A Multicenter Specimen Collection Protocol to Obtain Human Biological Samples for Research Studies

Clinical trial NCT00067054 - References