Chemotherapy-induced Neutropenia Clinical Trial
Official title:
Efficacy and Safety Phase II Study of Recombinant Human Serum Albumin/Granulocyte Colony-Stimulating Factor Fusion Protein for Injection to Prevent Neutrophilic Granulocytopenia Among Chemotherapy Patients
Verified date | November 2014 |
Source | Tianjin SinoBiotech Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to evaluate the dosages of recombinant human serum
albumin/granulocyte colony-stimulating factor fusion protein by injection for preventing
neutrophilic granulocytopenia among chemotherapy patients.
Conduct Pharmacokinetics (PK) study on recombinant human serum albumin/granulocyte
colony-stimulating factor fusion protein with recombinant human granulocyte
colony-stimulating factor injection as a control.
Status | Completed |
Enrollment | 216 |
Est. completion date | April 26, 2016 |
Est. primary completion date | December 23, 2015 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Age 18-65. - Diagnosed breast cancer, suitable for TEC or TE . - ECOG performance status 0 or 1. - Adjuvant chemotherapy; new adjuvant chemotherapy; newly diagnosed class ? and prior chemotherapy. - ANC=1.5×10 9/L, PLT=100×10 9/L. No bone marrow metastasis,blood coagulation function normally, no Hemorrhagic tendency. - No obvious abnormal ecg examination. - TBIL, ALT, AST=2.5×ULN (=5×ULN if presence of hepatic metastases). - Cr, BUN=2.5×ULN. - Signed informed consent. Exclusion Criteria: - Chemotherapy within past 4 weeks - Uncontrolled inflammatory disease,axillary temperature=38?. - Merging other malignant tumor - Pregnancy or nursing status. - Participation in another clinical trial with and investigational product within 3 months prior to study entry. - Severe diabetes mellitus, or poor blood sugar controller. - Allergic disease or allergic constitution. History of protein allergy. - History of drug addiction and alcoholism. - Hematopoietic stem cell transplantation or organ transplantation. - Chronic disease of severe cardiac, kidney and liver. - Other conditions that would be excluded from this study according to doctors'judgment |
Country | Name | City | State |
---|---|---|---|
China | Cancer Hospital, Chinese Academy of Medical Scienses | Beijing |
Lead Sponsor | Collaborator |
---|---|
Tianjin SinoBiotech Ltd. |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The mean of duration for class IV neutrophilic granulocytopenia | 4 weeks | ||
Secondary | The mean of duration for class IV neutrophilic granulocytopenia | 8 weeks | ||
Secondary | The mean of duration for ANC up to 2.0×109/L | 8 weeks | ||
Secondary | ANC | 8 weeks | ||
Secondary | The usage of antibiotics | 8 weeks | ||
Secondary | febrile neutropenia | 8 weeks |
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