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NCT00211146 - An Open-Label, Randomized, Parallel-Group Study to Confirm the Safety and Efficacy of Epoetin Alfa (PROCRIT) Administered Perioperatively vs. the Standard of Care in Blood Conservation in Subjects Undergoing Major Elective Spinal Surgery

An Open-Label, Randomized, Parallel-Group Study to Confirm the Safety and Efficacy of Epoetin Alfa (PROCRIT) Administered Perioperatively vs. the Standard of Care in Blood Conservation in Subjects Undergoing Major Elective Spinal Surgery


CSR Summary

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Annotated CRF

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Product Info

Generic Name
Epoetin alfa
Product Name
PROCRIT®
Therapeutic Area
Blood and Lymph Conditions
Enrollment
680
% Female
88.4%
% White
85.1%
Product Class
Hematologic Agents
Sponsor Protocol Number
PR97-19-002
Data Holder
Johnson & Johnson
Condition Studied
Anemia, Venous Thrombosis
Mean/Median Age (Years)
59.8

Supporting Documentation

Clinical Study Report
Collected Datasets
Protocol with Amendments
Statistical Analysis Plan
Study Phase 
3

Disclaimer

Clinical study data provided through this site do not replace the official labeling of a given drug product, which presents benefits and risks of the product for approved use(s). Before prescribing any product, health care professionals should consult the current prescribing information approved in their country. Patients seeking information may consult with their health care professional about the product, for which health authority approved written patient information may be available.