Study to evaluate the efficacy and tolerability of Pegfilgrastim in chemotherapy induced neutropenia
- Registration Number
- CTRI/2009/091/000579
- Lead Sponsor
- GENNOVA BIOPHARMACEUTICALS LTD
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 0
Patients able to understand and voluntarily provide written informed consent before screening, following an explanation of the nature and purpose of this study
Patients able to adhere to the study visit schedule and other protocol requirements
Patients aged 18 years and above
Male patients or non-pregnant, non-lactating females
Nonmyeloid cancer patients receiving chemotherapy regimens Patients with serum creatinine < 4.5 mg/dL, serum aspartate aminotransferase [AST] < 120 IU/L and alanine aminotransferase [ALT] < 120 IU/L (all values <3 times ULN)
Women who are pregnant, lactating or of child bearing potential who are not practicing effective methods of contraception
Patients hypersensitive to study drugs, components or similar products.
Patients with severe chronic neutropenia
Patients with myeloid malignancies and myelodysplasia
Patients currently receiving radiation therapy or have completed radiation therapy within 14 days before study entry
Patients participated in another therapeutic clinical study (i.e., not an epidemiological study or genomic screening study) during the past 30 days, or are likely to simultaneously participate in another therapeutic clinical study
Patients with any active infection requiring systemic antimicrobial therapy
Known HIV or hepatitis patients
History or clinical evidence of a serious medical illness, including renal, hepatic, respiratory, cardiovascular, endocrine, neurologic, psychiatric, hematologic disease, which in the opinion of the investigator will interfere with study participation or with evaluation of the study results
History of, or known current problems with, substance abuse, or any medical, psychological, and/or social condition that may interfere with the patient's participation in the study
Any condition that could jeopardize the patient's safety and compliance, as judged by the investigator
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method eutropenia GradeTimepoint: Day 3, 7, 10 & 14 after test drug for 3 chemotherapy cycles
- Secondary Outcome Measures
Name Time Method Incidence and duration of febrile neutropeniaTimepoint: Day 3, 7, 10 & 14 after test drug for 3 chemotherapy cycles