WHO ICTRP trial

A clinical trial to study the effects of two drugs Peg G-CSF and Grafeel® in the…

CTRI/2009/091/000694 · Clinical Trials Registry India (CTRI) · Recruiting

Key facts

Trial ID CTRI/2009/091/000694
Public title A clinical trial to study the effects of two drugs Peg G-CSF and Grafeel® in the prevention of reduction in neutrophil counts in cancer patients caused by drugs used to treat cancer.
Scientific title A randomized, multi-center, open label study to evaluate the efficacy and safety of Peg G-CSF as compared to Grafeel® in the prophylaxis of severe neutropenia in cancer patients receiving cytotoxic chemotherapy.
Primary sponsor DR.REDDY'S LABORATORIES LTD.Biologics Development Centre , Survey No.47, Bachupalli, Qutubullapur, Hyderabad-500090, A.P, India Fax: +91-40-44644507, 91-40-23041418
Registry Clinical Trials Registry India (CTRI)
Recruitment status Recruiting
Study type Interventional
Phase Phase 3
Countries India
Interventions Intervention1: PEG-GCSF: 6 mg single dose administered via SC route Control Intervention1: Grafeel®: 5µg/kg/day administered via SC route.
Registration date Sep 25, 2009
Target size 150
Secondary IDs CDP/03/07
Registry page ctri.nic.in

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