Safety and Efficacy Trial of Recombinant Human Granulocyte Colony Stimulating Factor (GCSF)

PHASE3CompletedINTERVENTIONAL
Enrollment

126

Participants

Timeline

Start Date

October 31, 2007

Primary Completion Date

July 31, 2009

Study Completion Date

September 30, 2009

Conditions
Chemotherapy-Induced Neutropenia
Interventions
BIOLOGICAL

Recombinant Human GCSF (Shantha Biotechnics Limited)

Dose: 300 mcg/day administered subcutaneous/intravenous/continuous subcutaneous infusion for a minimum of 7 days and for a maximum of 14 days or till Neutrophil count of 10,000/mm3 is reached whichever is earlier

BIOLOGICAL

Neupogen

Dose: 300mcg/day administered subcutaneous/intravenous/continuous subcutaneous infusion for a minimum of 7 days and for a maximum of 14 days or till Neutrophil count of 10,000/mm3 is reached whichever is earlier

Trial Locations (7)

302004

SMS Medical College and Hospital, Jaipur

380009

Vedanta Institute of Medical Sciences, Ahmedabad

411016

Seth Ramdas Shah Memorial Hospital, Pune

500034

Indo American Cancer Institute and Research Centre, Hyderabad

Nizam's Institute of Medical Sciences, Hyderabad

682404

Lakeshore Hospital and Research Center, Kochi

695011

Regional Cancer Centre, Trivandrum

All Listed Sponsors
lead

Shantha Biotechnics Limited

INDUSTRY

NCT00776165 - Safety and Efficacy Trial of Recombinant Human Granulocyte Colony Stimulating Factor (GCSF) | Biotech Hunter | Biotech Hunter