UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019110 |
|---|---|
| Receipt number | R000022092 |
| Scientific Title | Efficacy and Cost Benefit in Filgrastim Biosimilar for Neutropenia in Patients Receiving Chemotherapy: A Single-center, Non-randomized Cohort Study |
| Date of disclosure of the study information | 2015/09/24 |
| Last modified on | 2015/09/29 19:48:49 |
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Basic information
Public title
Efficacy and Cost Benefit in Filgrastim Biosimilar for Neutropenia in Patients Receiving Chemotherapy: A Single-center, Non-randomized Cohort Study
Acronym
Efficacy of Filgrastim Biosimilar
Scientific Title
Efficacy and Cost Benefit in Filgrastim Biosimilar for Neutropenia in Patients Receiving Chemotherapy: A Single-center, Non-randomized Cohort Study
Scientific Title:Acronym
Efficacy of Filgrastim Biosimilar
Region
| Japan |
Condition
Condition
Gynecologic cancer
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
About the case that neutrophil count reducing symptom was found in with chemotherapy in ovarian cancer, cervical cancer, treatment of the uterine cancer, it is to examine the same class, the homogeneity (non-recessive) by the clinic of precedent article and this medicine, a safe evaluation and costs vs. the advantage.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Neutropenic (neutrophil count <1,000/mm3) period in each treatment cycle
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Injection method
Chemotherapy cycle 1
When febrile neutropenia [fever (axillary temperature with less than neutrophil count 1,000/mm3 more than 38 degrees Celsius)] develops at chemotherapy enforcement or when a neutrophil count confirms less than 500/mm3, we give 50 mcg/m2 of filgrastim BS notes subcutaneously once a day.
Chemotherapy cycle after two
We give 50 mcg/m2 of filgrastim BS notes subcutaneously once a day from a point in time when neutrophil counts decreased to less than 1,000/mm3 at chemotherapy enforcement.
Dosing period
When it recovers to a neutrophil count to aim for or when we achieve the time when a neutrophil count shows minimum in 5,000/mm3 after the course, we discontinue administration
Interventions/Control_2
Chemotherapy cycle 1
When febrile neutropenia [fever (axillary temperature with less than neutrophil count 1,000/mm3 more than 38 degrees Celsius)] develops at chemotherapy enforcement or when a neutrophil count confirms less than 500/mm3, we give 50 mcg/m2 of Gran notes subcutaneously once a day.
Chemotherapy cycle after two
We give 50 mcg/m2 of Gran notes subcutaneously once a day from a point in time when neutrophil counts decreased to less than 1,000/mm3 at chemotherapy enforcement.
Dosing period
When it recovers to a neutrophil count to aim for or when we achieve the time when a neutrophil count shows minimum in 5,000/mm3 after the course, we discontinue administration
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | < |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
Enforcement planned Patient
Performance status(PS)is the patient with hematopoiesis, liver, the renal function to meet criteria of Patient
following with 0-1 by the pharmacotherapy in the anticancer drug
Neutrophile count>1,500/mm3
Platelet>100,000/mm3
1.5 times of 1.5 times serum creatinine <institution reference value upper limit of 2.5 times total bilirubin<institution reference value upper limit of GOT and GPT <institution reference value upper limit
Key exclusion criteria
1) The patients with the bone marrow infiltration
2) Is the patients with hypersensitivity to Patient
3) G-CSF preparation which received radiotherapy within four weeks before registration at chemotherapy initiation
4) The patients who judged that a chief physician was inappropriate
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuhki Sato |
Organization
Oita University Hospital
Division name
Clinical Pharmacy
Zip code
Address
1-1, Idaigaoka, Hasama-machi, Yuhu, Oita
TEL
097-586-6101
syuhki@oita-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuhki Sato |
Organization
Oita University Hospitaly
Division name
Clinical Pharmacy
Zip code
Address
1-1, Idaigaoka, Hasama-machi, Yuhu, Oita
TEL
097-586-6101
Homepage URL
syuhki@oita-u.ac.jp
Sponsor or person
Institute
Oita University Hospital
Institute
Department
Personal name
Funding Source
Organization
Oita University Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 09 | Month | 24 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2014 | Year | 07 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 08 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 09 | Month | 24 | Day |
Last modified on
| 2015 | Year | 09 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022092
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