Clinical trials: Chemotherapy-induced Neutropenia
Chemotherapy Induced Neutropenia
Phase II Study of DA-3031(PEG-G-CSF) in Chemotherapy-induced Neutropenia
This study is to examine which dose of DA-3031(PEG-G-CSF) has similar efficacy and safety compared to daily G-CSF in chemotherapy-induced neutropenia.
- Trial name
- PEG-G-CSF (NCT01923545)
- Testing
- PEG-G-CSF, G-CSF
- Where
- South Korea
- Volunteers
- 61 people
- Sponsor
- Dong-A ST Co., Ltd.
Neutropenia
Dose Finding Study of KRN125 (Pegfilgrastim) for Treatment of Neutropenic Patients
To assess the duration of severe neutropenia in cycle 1 of chemotherapy after treatment with a single injection of KRN125 or multiple daily injections of filgrastim.
- Trial name
- NCT00364468
- Testing
- pegfilgrastim
- Where
- 6 sites in Japan
- Volunteers
- 107 people
- Sponsor
- Kyowa Kirin Co., Ltd.
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.
Chemotherapy-induced Neutropenia
Tolerability and Pharmacokinetics(PK)/Pharmacodynamics(PD) Study of GW003 in Healthy Subjects
This study is designed to access the tolerability and Pharmacokinetic/Pharmacodynamic (PK/PD) of single subcutaneous (SC) injection of GW003 in healthy subjects.
- Trial name
- NCT02643901
- Testing
- GW003
- Where
- China
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Jiangsu T-Mab Biopharma Co.,Ltd
Febrile Neutropenia, Cancer
Multi-level Evaluation of Chemotherapy-induced Febrile Neutropenia Prophylaxis, Outcomes, and Determinants With Granulocyte-colony Stimulating Factor
This international, prospective, observational, open-label, pharmaco-epidemiologic study observes cancer patients at risk for chemotherapy-induced febrile neutropenia (FN) who are receiving filgrastim biosimilar (EP2006) for…
- Conditions
- Febrile Neutropenia, Cancer, Breast Cancer, Ovarian Cancer
- Trial name
- Monitor-GCSF (NCT01459653)
- Where
- 117 sites in Austria, Belgium and 10 more
- Volunteers
- 1,496 people
- Sponsor
- Sandoz
Chemotherapy-induced Neutropenia
Study to Assess the Safety, Tolerability, and Pharmacokinetics/Pharmacodynamics of GW003 in Patients With Breast Cancer
The purpose of the present trial is to evaluate the safety, tolerability and pharmacokinetics(PK)/pharmacodynamics(PD) of single subcutaneous injection of GW003 in breast cancer patients.
- Trial name
- NCT02725606
- Testing
- Pegylated Recombinant Human G-CSF, GW003
- Where
- China
- Volunteers
- 30 people
- Sponsor
- Jiangsu T-Mab Biopharma Co.,Ltd
Chemotherapy-induced Neutropenia, Breast Cancer
Phase III Study Comparing the Efficacy and Safety of LA-EP2006 and Peg-Filgrastim
The study will assess the efficacy of LA-EP2006 compared to Neulasta® with respect to the mean duration of severe neutropenia during treatment with myelosuppressive chemotherapy in breast cancer patients.
- Trial name
- PROTECT2 (NCT01516736)
- Testing
- LA-EP2006, Neulasta®
- Where
- 53 sites in United States, Argentina and 6 more
- Volunteers
- 308 people
- Sponsor
- Sandoz
Chemotherapy-Induced Neutropenia, Breast Cancer
Evaluation of Maxy-G34 in Breast Cancer Patients Treated With TAC (Docetaxel, Adriamycin, Cyclophosphamide) Chemotherapy
This is an investigation of the safety and efficacy of Maxy-G34 in breast cancer patients treated with TAC chemotherapy. Maxy-G34 will be given as a single injection during each cycle of chemotherapy, for a planned total of six…
- Trial name
- NCT00501332
- Testing
- Maxy-G34
- Where
- 15 sites in Poland, Romania and 2 more
- Volunteers
- 30 people
- Sponsor
- Maxygen Holdings Ltd.
Chemotherapy-induced Neutropenia
Neugranin in Breast Cancer Participants Receiving Doxorubicin/Docetaxel
Determination of the effect of neugranin on the duration and severity of severe neutropenia in participants receiving doxorubicin in combination with docetaxel.
- Trial name
- NEUGR-003 (NCT01126190)
- Testing
- Neugranin, Pegfilgrastim, Chemotherapy
- Where
- 59 sites in Bulgaria, Romania and 3 more
- Volunteers
- 381 people
- Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
Chemotherapy-induced Neutropenia, Cancer, Breast
Fusion Protein rHSA/GCSFclinical Study on Breast Cancer Patients
The purpose of this study is to evaluate the tolerance and safety of the rHSA/GCSF in breast cancer patients with different doses and multiple injections.
- Trial name
- NCT03246009
- Testing
- rHSA/GCSF
- Where
- China
- Volunteers
- 24 people
- Sponsor
- Tianjin SinoBiotech Ltd.
Chemotherapy-induced Febrile Neutropenia
Prospective Observational Study of Febrile Neutropenia (FN) and Pegfilgrastim Primary Prophylaxis in Breast Cancer and Non-Hodgkin's Lymphoma Patients Receiving High (>20%) FN-risk Chemotherapy
To estimate the incidence of febrile neutropenia in patients with breast cancer and non-Hodgkin's lymphoma receiving high (> 20%) FN-risk chemotherapy and pegfilgrastim primary prophylaxis.
- Trial name
- NCT02178475
- Where
- 74 sites in Austria, Belgium and 7 more
- Volunteers
- 943 people
- Sponsor
- Amgen
Neoplasms (no Otherwise Specified)
A Clinical Trial of Patients With Solid Tumours Receiving Granulocyte Colony Stimulating Factor as Primary Prophylaxis for Chemotherapy-induced Neutropenia, in a Docetaxel Based Regimen
Primary Objective: To evaluate the incidence and severity of neutropenia in patients being treated for solid tumours with a Taxotere® based regimen when Granocyte® 34 is being used as a primary prophylaxis for…
- Trial name
- Grano-Tax (NCT01107756)
- Testing
- LENOGRASTIM (GRANOGYTE 34)
- Where
- 25 sites in South Africa
- Volunteers
- 403 people
- Sponsor
- Sanofi
Breast Cancer, Neutropenia
Study to Compare the Efficacy and Safety of F-627 and GRAN®
A Phase III, Multi-Center, Randomized, Open-Label, Active-Controlled Trial to Compare the Efficacy and Safety of Recombinant Human Granulocyte Colony Stimulating Factor-Fc Fusion Protein (F-627) and Recombinant Human Granulocyte…
- Trial name
- NCT04174599
- Testing
- F-627, GRAN®
- Where
- China
- Volunteers
- 242 people
- Sponsor
- EVIVE Biotechnology
Neutropenia, Chemotherapy-Induced Febrile, Breast Neoplasm Female
Study Evaluating PEG-G-CSF Injectionin Preventing Neutropenia After Chemotherapy
To evaluate the efficacy, safety, and immunogenicity of PEG-G-CSF Injection (Kexing Biopharmaceutical Co., Ltd.) for the prevention of neutropenia after chemotherapy, using the PEG-G-CSF Injection ( Neulasta®, Amgen Europe B.V.)…
- Trial name
- NCT06711523
- Testing
- PEG-G-CSF injection (Kexing Biopharmaceutical Co., Ltd.), PEG-G-CSF injection (Neulasta®，Amgen Europe B.V.)
- Where
- China
- Volunteers
- 250 people
- Sponsor
- Kexing Biopharm Co., Ltd.
Chemotherapy-induced Neutropenia
Plinabulin vs. Pegfilgrastim in Prevention of TAC Induced Neutropenia
The primary purpose of this study is to compare the percentage of patients with Duration of Severe Neutropenia (DSN) =0 in patients treated with: Docetaxel, doxorubicin, and cyclophosphamide (TAC) + pegfilgrastim versus…
- Trial name
- NCT03294577
- Testing
- Pegfilgrastim, Plinabulin, Docetaxel, doxorubicin, and cyclophosphamide (TAC)
- Where
- 20 sites in China, Ukraine
- Volunteers
- 221 people
- Sponsor
- BeyondSpring Pharmaceuticals Inc.
Acute Myeloid Leukemia, Neutropenia
Safety and Efficacy of Human Myeloid Progenitor Cells (CLT-008) During Chemotherapy for Acute Myeloid Leukemia
The purpose of the study is to explore the safety and efficacy of CLT-008 as an extra supportive care measure after induction chemotherapy for patients with acute myeloid leukemia (AML).
- Conditions
- Acute Myeloid Leukemia, Neutropenia, Infection
- Trial name
- NCT02282215
- Testing
- CLT-008, G-CSF
- Where
- 22 sites in United States
- Volunteers
- 163 people
- Sponsor
- Cellerant Therapeutics
Neutropenia in Breast Cancer
A Non-inferiority Study Comparing Two Filgrastim Preparations in Breast Cancer
This study primary objective and endpoints are compare the efficacy of two products containing filgrastim, evaluating if the formulation produced by Eurofarma can be considered non-inferior to the reference product.
- Trial name
- NCT01079676
- Testing
- Filgrastim (Eurofarma), Filgrastim (Granulokine, Amgen)
- Where
- 6 sites in Brazil
- Volunteers
- 220 people
- Sponsor
- Eurofarma Laboratorios S.A.
Solid Tumors, Malignant Hemopathy
Nivestim® (Filgrastim) Tolerance in Patients Treated by Toxic Chemotherapeutic Agents
The main aim of the study is to assess the safety of Nivestim® treatment in patients treated with neutropenia-inducing chemotherapy for a malignant disease, solid tumor or a malignant hemopathy.
- Conditions
- Solid Tumors, Malignant Hemopathy, Chemotherapy-induced Febrile Neutropenia (FN)
- Trial name
- NCT01574235
- Testing
- Nivestim®
- Where
- 87 sites in France
- Volunteers
- 2,114 people
- Sponsor
- Hospira, now a wholly owned subsidiary of Pfizer
Chemotherapy Induced Neutropenia
GCPGC in Chemotherapy-induced Neutropenia
This study is adaptive design and it consists of stage I and stage II. Stage I is multi-center, parallel-group, single-blind, phase II study to determine the adequate dose of GCPGC in chemotherapy-induced neutropenia.
- Trial name
- NCT01328938
- Testing
- GCPGC 3.6mg, GCPGC 6mg, Neulasta (pegfilgrastim) 6mg
- Where
- 15 sites in South Korea
- Volunteers
- 177 people
- Sponsor
- Green Cross Corporation
Chemotherapy-induced Neutropenia
Study of Recombinant Human Serum Albumin/Granulocyte Colony-Stimulating Factor Fusion Protein
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.
- Trial name
- NCT02465801
- Testing
- HSA-GCSF 1.2 mg, HSA-GCSF 1.5 mg, GCSF
- Where
- China
- Volunteers
- 216 people
- Sponsor
- Tianjin SinoBiotech Ltd.