Safety and Efficacy Trial of Recombinant Human Granulocyte Colony Stimulating Factor (GCSF)
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ClinicalTrials.gov Identifier: NCT00776165 |
Recruitment Status :
Completed
First Posted : October 21, 2008
Last Update Posted : February 3, 2010
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A Phase III Randomized Controlled Open Label Comparative Multicentric Trial To Compare The Safety And Efficacy of Indigenous Recombinant Human Granulocyte Colony Stimulating Factor (rhG-CSF) With Neupogen In Patients on Myelosuppressive Therapy for Non Myeloid Malignancies.
Adult patients (18 years of age or older) diagnosed as having any malignancy (except myeloid malignancy, ECOG status of 0-2 and having a history of experiencing neutropenia (absolute neutrophil count < 1000/mm3) in a previous chemotherapy cycle and have one more cycle of chemotherapy on the same drugs would be recruited into the study.
Treatment will be initiated not earlier than 24 hours after the administration of cytotoxic chemotherapy in both groups.
Group 1: Recombinant Human Granulocyte Colony Stimulating Factor (rhG-CSF)(Shantha)
- 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 Group 2: Neupogen (rhG-CSF)
- 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 Primary End Point would be to evaluate the percentage of patients developing febrile neutropenia (defined as body temperature ≥ 38.2°C or developing a temperature of > 38°C twice in a 12-hour period and absolute neutrophil count < 0.5 x 109/L on the same day of the fever or the day after)in the two treatment groups.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Chemotherapy-Induced Neutropenia | Biological: Recombinant Human GCSF (Shantha Biotechnics Limited) Biological: Neupogen | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 126 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | A Phase 3 Randomized Controlled Open Label Comparative Multicentric Trial To Compare The Safety And Efficacy of Indigenous Recombinant Human Granulocyte Colony Stimulating Factor (rhG-CSF) With Neupogen In Patients on Myelosuppressive Therapy for Non Myeloid Malignancies. |
Study Start Date : | October 2007 |
Actual Primary Completion Date : | July 2009 |
Actual Study Completion Date : | September 2009 |

Arm | Intervention/treatment |
---|---|
Experimental: 1
Recombinant Human Granulocyte Colony Stimulating Factor (rhG-CSF)(Shantha) 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
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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 |
Active Comparator: 2
Neupogen (rhG-CSF) 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
|
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 |
- Percentage of patients developing febrile neutropenia (defined as body temperature ≥ 38.2°C or developing a temperature of > 38°C twice in a 12-hour period and absolute neutrophil count < 0.5 x 10e9/L on the same day of the fever or the day after. [ Time Frame: End of study ]
- Percentage of patients developing adverse events and/ or changes in laboratory values. [ Time Frame: End of study ]
- Incidence of neutropenia defined as absolute neutrophil count < 0.5 x 10e9/L not associated with fever [ Time Frame: End of study ]
- Incidence of need for IV anti-infectives and days of admission, as a result of neutropenia [ Time Frame: End of study ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients of either sex aged 18 yrs or more
- Patients diagnosed having any malignancy (except myeloid malignancies and myelodysplastic syndromes) receiving standard combination chemotherapy.
- Patients experiencing neutropenia (absolute neutrophil count < 1000/mm3) in a previous chemotherapy cycle and have one more cycle of chemotherapy on the same drugs.
- Patients should have performance status of 0-2 ECOG (European Cooperative Oncology group).
Exclusion Criteria:
- Patients unwilling to give informed consent or unable to follow study procedures
- Patients requiring autologous or allogenic stem cell transplantation.
- Patients having active infection
- Patients who have taken antibiotics or colony stimulation factor within the previous 10 days
- Patients who have clinically significant uncontrolled medical illness except malignancy
- Patients having renal impairment (serum creatinine > 1.5 times the upper normal limit) and abnormal liver function (bilirubin > 5 times the upper limit of normal)
- Pregnant or lactating women
- Patients who have involvement of bone marrow
- Patients receiving simultaneous radiotherapy

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00776165
India | |
Indo American Cancer Institute and Research Centre | |
Hyderabad, Andhra Pradesh, India, 500034 | |
Nizam's Institute of Medical Sciences | |
Hyderabad, Andhra Pradesh, India, 500034 | |
Vedanta Institute of Medical Sciences | |
Ahmedabad, Gujrat, India, 380009 | |
Lakeshore Hospital and Research Center | |
Cochin, Kerala, India, 682404 | |
Regional Cancer Centre | |
Trivandrum, Kerala, India, 695011 | |
Seth Ramdas Shah Memorial Hospital | |
Pune, Maharashtra, India, 411016 | |
SMS Medical College and Hospital | |
Jaipur, Rajasthan, India, 302004 |
Study Director: | Raman Rao, MD | Shantha Biotechnics Limited, Hyderabad, India |
Responsible Party: | Dr. Raman Rao, Shantha Biotechnics Limited, Hyderabad, India |
ClinicalTrials.gov Identifier: | NCT00776165 |
Other Study ID Numbers: |
SBL/GCSF/N/2007/0100 |
First Posted: | October 21, 2008 Key Record Dates |
Last Update Posted: | February 3, 2010 |
Last Verified: | February 2010 |
Neutropenia Agranulocytosis Leukopenia Leukocyte Disorders Hematologic Diseases |