RPCEC00000104CompletedPhase 4
Comparison of two formulations of human recombinant Granulocyte Colony Stimulator Factor (G-CSF) in peripheral blood cells mobilization.
Center for Genetic Engineering and Biothecnology (CIGB), in Havana.0 sites35 target enrollmentStarted: April 30, 2011Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 35
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized controlled trial. Masking: Open. Control group: Active. Assignment: Parallel. Purpose: Treatment
Eligibility Criteria
- Ages
- 18 years to o limit (—)
- Sex
- All
Inclusion Criteria
- •1.Age major than 18 years old. 2.Informed consent. 3.Patients requiring peripheral blood cells mobilization. 4.ANC within normal limits before inclusion (ANC = 3 x 109/L). 5.Platelet Blood Count within normal limits before inclusion (PBC = 150 x 109/L).
Exclusion Criteria
- •1.Allergic reaction to GCSF or their ingredients. 2.Malignancies. 3.Chronic or acute liver disease: Bilirrubin >17 micromol/L, SGPT y/o SGOT 1.5 times over their limits, alcalin Fosfatasa 2.5 x upper normal limit (44-147 UI/L). 4.Previous chemotherapy or radiotherapy, 4 weeks before the inclusion. 5.Serious psychiatric disorder or other limitation that contraindicates informed consent or study evaluations. 6.Bone marrow disorder that affect mobilization. 7.Un controlled chronic disease: heard disease, Renal insufficiency, Liver disease, Diabetes Mellitus. 8.Infection that contraindicate some phases of transplant. 9.Young women without effective contraception.
Investigators
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