Clinical trials: PEG-rhG-CSF
Non Small Cell Lung Cancer, Breast Cancer
Safety and Efficacy of YPEG-rhG-CSF in Cancer Patients Receiving Chemotherapy
This study is to examine which dose of YPEG-rhG-CSF, once-per-cycle, has similar efficacy and safety, comparing to PEG-rhG-CSF, once-per-cycle, in chemotherapy-induced neutropenia
- Trial name
- NCT02005458
- Testing
- YPEG-rhG-CSF, 20μg/kg, single s.c. at 48hrs after chemotherapy for each experimental cycle, YPEG-rhG-CSF, 30μg/kg, single s.c. at 48hrs after chemotherapy for each experimental cycle, YPEG-rhG-CSF, 45μg/kg, single s.c. at 48hrs after chemotherapy for each experimental cycle
- Where
- 12 sites in China
- Volunteers
- 80 people
- Sponsor
- Xiamen Amoytop Biotech Co., Ltd.
Lymphoma
PEG-rhG-CSF in Patients With Lymphoma Receiving Chemotherapy
The purpose of this study is to estimate the safety and efficacy of PEG-rhG-CSF in patients with lymphoma receiving chemotherapy.
- Trial name
- NCT02805218
- Testing
- PEG-rhG-CSF
- Volunteers
- 410 people
- Sponsor
- CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.
Elderly Lymphoma Patients
Evaluation of the Application of PEGylated Recombinant Human Granulocyte Stimulating Factor Injection (PEG-rhG-CSF) in Chemotherapy of Elderly Lymphoma Patients
A multicenter, open, one-arm clinical study evaluated the efficacy and safety of Jinyouli in preventing neutropenia after chemotherapy in elderly lymphoma patients who met the criteria for admission.
- Trial name
- NCT03870412
- Testing
- PEG-rhG-CSF
- Where
- China
- Volunteers
- 485 people
- Sponsor
- CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.
Patients With Nonmyeloid Malignancies Receiving Antineoplastic Therapy Based on Chemotherapy Regimens at Moderate to High Febrile Neutropenia (FN) Risk
A Trial of HHPG-19K Injection and Auto-HHPG-19K Injection in Prevention of Chemotherapy-related Moderate to Severe Neutropenia of Patients With Nonmyeloid Malignancies
The study is being conducted to evaluate the preference, and safety of HHPG-19K Injection and Auto-HHPG-19K Injection in Prevention of chemotherapy-related moderate to severe neutropenia of Patients with nonmyeloid malignancies.
- Trial name
- NCT06254742
- Testing
- HHPG-19K Injection
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Hemophagocytic Syndrome
Evaluate the Efficacy and Safety of PEG-rhG-CSF in Patients With Hemophagocytic Syndrome
Hemophagocytic syndrome (HPS), also known as hemophagocytic lymphohistiocytosis (HLH), is an immune mediated life-threatening disease. There is no uniform recommendation for salvage treatment of HLH.
- Trial name
- NCT04500886
- Testing
- PEG-rhG-CSF, rhG-CSF
- Where
- China
- Volunteers
- 50 people
- Sponsor
- CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.
Preeclampsia
Safety, Tolerability, and PK/PD of Telpegfilgrastim in Premenopausal Non-pregnant Females
This is an open-label, Phase Ia clinical study to evaluate the safety, tolerability, and pharmacokinetic/pharmacodynamic (PK/PD) characteristics of single dose of telpegfilgrastim injection in healthy premenopausal non-pregnant…
- Trial name
- NCT06893796
- Testing
- Telpegfilgrastim Injection
- Where
- China
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Xiamen Amoytop Biotech Co., Ltd.
Preeclampsia
Safety, Tolerability, and PK/PD of Telpegfilgrastim Injection in Non-pregnant Females of Childbearing
This is an open-label, single-arm, Phase Ⅰa clinical study designed to evaluate the safety, tolerability, and pharmacokinetic/pharmacodynamic (PK/PD) characteristics of multiple doses of Telpegfilgrastim Injection in non-pregnant…
- Trial name
- NCT06924385
- Testing
- Telpegfilgrastim Injection
- Where
- China
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Xiamen Amoytop Biotech Co., Ltd.
Advanced Pancreatic Cancer
Efficacy and Safety of Pegylated Recombinant Human Granulocyte Stimulating Factor in Secondary Prevention of Albumin Paclitaxel Combined With S-1 in the First-line Treatment of Advanced Pancreatic Cancer
A prospective, open, one-arm clinical study to evaluate the efficacy and safety of jinyouli in the first-line treatment of advanced pancreatic cancer with albumin paclitaxel combined with S-1.Chemotherapy regimen: (1)…
- Trial name
- NCT04239001
- Testing
- PEG-rhG-CSF
- Where
- China
- Volunteers
- 20 people
- Sponsor
- CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.
Breast Cancer
PEG-rhG-CSF in Patients With Breast Cancer Receiving Chemotherapy
The purpose of this study is to evaluate the efficacy and safety of PEG-rhG-CSF in patients with breast cancer receiving chemotherapy
- Trial name
- NCT02805153
- Testing
- PEG-rhG-CSF, rhG-CSF
- Volunteers
- 215 people
- Sponsor
- CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.
Breast Cancer, Neutropenia
A Phase II Study Comparing Pegylated rhG-CSF（HHPG-19K） and rhG-CSF in Breast Cancer Patients Receiving Chemotherapy
Neutropenia is one of the most frequent adverse effects of chemotherapy, and the main factor to limit the dosage and the continuation of chemotherapy.
- Conditions
- Breast Cancer, Neutropenia, Febrile Neutropenia
- Trial name
- NCT02119715
- Testing
- Pegylated rhG-CSF 100μg/kg, Pegylated rhG-CSF:150 μg/kg, rhG-CSF 5 μg/kg/day
- Where
- China
- Volunteers
- 182 people
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Malignant Solid Tumors
PEG-rhG-CSF in Patients With Malignant Solid Tumors Receiving Chemotherapy
The purpose of this study is to estimate the safety and efficacy of PEG-rhG-CSF in patients with lung cancer,head and neck cancer,colorectal cancer,and ovarian cancer receiving multi-cycle chemotherapy.
- Trial name
- NCT02805166
- Testing
- PEG-rhG-CSF
- Volunteers
- 420 people
- Sponsor
- CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.
Lymphoma, Leukemia
Evaluate the Efficacy and Safety of the Prophylactic Use of PEG-rhG-CSF in Children With Hematological Malignancies
The incidence of infectious complications in hematological malignancies is higher than that in children with solid tumors, which may be related to the type and dose intensity of chemotherapy regimens used in hematological tumors.
- Trial name
- NCT04497701
- Testing
- PEG-rhG-CSF group, rhG-CSF group
- Where
- China
- Volunteers
- 139 people
- Sponsor
- CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.
Non Hodgkin's Lymphoma
Evaluate the Efficacy and Safety of PEG-rhG-CSF in Preventing Neutropenia After Chemotherapy in Patients With Non-Hodgkin's Lymphoma
The main treatments for non-Hodgkin's lymphoma are surgery, radiotherapy, chemotherapy, and bone marrow transplantation. Neutropenia is the most common and serious complication of most chemotherapy.
- Trial name
- NCT04497688
- Testing
- PEG-rhG-CSF
- Where
- China
- Volunteers
- 104 people
- Sponsor
- CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.
Breast Cancer Female
Trial to Compare the Efficacy and Safety Of MW05 and PEG-rhG-CSF
In the study, subjects will scheduled to undergo four 21-days cycles of chemotherapy treatment. Three group were treated with MW05 300 μg/kg or MW05 500 μg/kg or PEG-rhG-CSF 100 μg/kg on the 3th day of each cycle randomized 1:1:1…
- Trial name
- NCT04554056
- Testing
- MW05, PEG-rhG-CSF
- Where
- China
- Volunteers
- 586 people
- Sponsor
- Mabwell (Shanghai) Bioscience Co., Ltd.
Breast Cancer
PEG-rhG-CSF in Patients With Breast Cancer Receiving Chemotherapy to Prevent Neutropenia
The purpose of this study is to estimate the efficacy and safety of PEG-rhG-CSF in patients with breast cancer receiving chemotherapy.
- Trial name
- NCT02805205
- Testing
- PEG-rhG-CSF
- Volunteers
- 484 people
- Sponsor
- CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.
Small Cell Lung Cancer, PEG-rhG-CSF
PEG-rhG-CSF in Elderly Patients With Small Cell Lung Cancer Receiving Chemotherapy
Evaluation of the efficacy and safety of Jinyouli in preventing neutropenia in multiple chemotherapy cycles in elderly patients with small cell lung cancer through a multicenter, open, one-arm study Subjects with newly diagnosed…
- Trial name
- NCT03776604
- Testing
- PEG-rhG-CSF
- Where
- China
- Volunteers
- 61 people
- Sponsor
- CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.
Chemotherapy-induced Neutropenia, Myelosuppression
Real World Study of PEG-rhG-CSF in Prevention of Chemotherapy-induced Neutropenia
The aim of this study is to observe and evaluate the cost-effectiveness,efficacy and safety of PEG-rhG-CSF in preventing chemotherapy-induced neutropenia(CIN) of cancer patients in the real world.1000 patients with non-myeloid…
- Trial name
- NCT03846414
- Testing
- PEG-rhG-CSF
- Volunteers
- 1,500 people
- Sponsor
- CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.