Clinical trials: Chemotherapy-induced Neutropenia
Chemotherapy-induced Neutropenia
A Safety and PK Study of EC-18 in Healthy Subjects
The purpose of this study is to determine if EC-18 is safe and tolerable in healthy subjects.
- Trial name
- NCT02496143
- Testing
- EC-18
- Where
- United States
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- Enzychem Lifesciences Corporation
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
Study of the Efficacy and Safety of Empegfilgrastim for Neutropenia Prophylaxis in Breast Cancer Patients
The purpose of the study is to compare safety and efficacy of a single dose of empegfilgrastim and daily dosing of filgrastim for prevention of neutropenia in patients receiving AT (docetaxel 75 mg/m2 + doxorubicin 50 mg/m2).
- Trial name
- NCT02104830
- Testing
- Empegfilrastim 6 mg, Filgrastim, Empegfilrastim 7.5 mg
- Where
- 13 sites in Russia
- Volunteers
- 135 people
- Sponsor
- Biocad
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.
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.
Chemotherapy-induced Neutropenia
Randomized Phase 2, Dose-finding Efficacy, Safety Study of ANF-RHO™ Versus Neulasta® in Chemotherapy-Induced Neutropenia
Randomized, Open-Label study to determine the dose, efficacy, safety and pharmacokinetic profile of ANF-RHO™ with once-per-cycle injection in comparison with Neulasta in Breast Cancer patients at high risk of developing…
- Trial name
- NCT03559387
- Testing
- ANF-RHO™, Neulasta®
- Where
- 8 sites in France, Netherlands
- Volunteers
- 9 people
- Sponsor
- Prolong Pharmaceuticals
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.
Neutropenic Complications, Breast Neoplasms
Phase III Study Comparing the Efficacy and Safety of LA-EP2006 and Neulasta®
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.
- Conditions
- Neutropenic Complications, Breast Neoplasms, Chemotherapy-induced Neutropenia, Chemotherapeutic Toxicity
- Trial name
- PROTECT-1 (NCT01735175)
- Testing
- LA-EP2006, Neulasta®
- Where
- 41 sites in Brazil, India and 4 more
- Volunteers
- 316 people
- Sponsor
- Sandoz
Chemotherapy-induced Neutropenia
Plinabulin vs. Pegfilgrastim in Patients With Solid Tumors Receiving Docetaxel Myelosuppressive Chemotherapy Phase 3
To assess Duration of Severe Neutropenia (DSN) in treatment Cycle 1 in patients with advanced or metastatic breast cancer, who have failed >/= 1 but < 5 prior lines of chemotherapy; locally advanced or metastatic non small cell…
- Trial name
- Protective-1 (NCT03102606)
- Testing
- Plinabulin, Pegfilgrastim
- Where
- 18 sites in United States, China and 2 more
- Volunteers
- 105 people
- Sponsor
- BeyondSpring Pharmaceuticals Inc.
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
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.
Prevention of Chemotherapy-induced Myelosuppression
A Study of ALRN-6924 for Protection of Chemotherapy-Induced Side Effects in Patients With TP53-Mutant Breast Cancer
This is a Phase 1b open-label, single arm, multicenter, study of ALRN-6924 as a chemoprotection agent in patients with TP53-mutated HER2- breast cancer (stages IIa to IIIb) receiving neoadjuvant or adjuvant chemotherapy with…
- Trial name
- NCT05622058
- Testing
- ALRN-6924, TAC (doxorubicin 50 mg/m2; cyclophosphamide 500 mg/m2; docetaxel 75 mg/m2)
- Where
- 14 sites in United States, Bosnia and Herzegovina and 2 more
- Volunteers
- 6 people
- Sponsor
- Aileron Therapeutics, Inc.
MBL-Deficient, Neutropenia
Study on Mannan Binding Lectin (MBL) Substitution in MBL-Deficient Children With Chemotherapy-Induced Neutropenia
The pharmacokinetics, and clinical and biological effects of MBL replacement therapy in MBL-deficient children during chemotherapy-induced neutropenia were studied.
- Trial name
- NCT00138736
- Testing
- Mannan Binding Lectin (MBL), Mannan Binding Lectin
- Where
- 2 sites in Netherlands
- Volunteers
- 12 people
- Sponsor
- Prothya Biosolutions
Breast Cancer
Pegfilgrastim-gema Compared to Pegfilgrastim-roche for Prevention of Induced Neutropenia in Breast Cancer Patients.
This is a randomized, multicentre, Phase 3 study. Patients will be randomly assigned to the Study drug or its comparator. The study will be blinded for the staff members in charge of the endpoint assessment.
- Trial name
- NCT03404752
- Testing
- Peg-Filgrastim
- Where
- Argentina
- Volunteers
- 120 people
- Sponsor
- Gema Biotech S.A.
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
Evaluation of the Food Effect on the Safety, Tolerability, PK of EC-18 After Oral Administration in Healthy Volunteers
A Randomized, Open-Label, Single -Dose, Crossover, Phase I Clinical Trial to Evaluate the Effect of Food on the Safety, Tolerability and Pharmacokinetics of EC-18 after Oral Administration in Healthy Volunteers
- Trial name
- NCT02700360
- Testing
- high-fat diet, EC-18
- Where
- South Korea
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Enzychem Lifesciences Corporation
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.
Breast Cancer Female
Nanogen Pegcyte Clinical Study for the Prevention of CIN in Breast-cancer Patients.
Accelerated AC regimen-Doxorubicin 60 mg/m2,Cyclophosphamide 600 mg/m2 on day 1 \& day 14 of each cycle along with G-CSF support for up to 4 cycles, followed by Paclitaxel 175 mg/m2 in the next 4 cycles is the standard clinical…
- Trial name
- NCT03381417
- Testing
- pegcyte, Neulastim
- Where
- Vietnam
- Volunteers
- 128 people
- Sponsor
- Nanogen Pharmaceutical Biotechnology Joint Stock Company
Chemotherapy-Induced Neutropenia
Use of Biosimilar Nivestim® to Prevent Chemo-induced Neutropenia. Real Life Study
The aim of this study is to describe in real-life conditions the determinants of use of GCSF (Granulocyte Colony-Stimulating Factor) Nivestim® in primary or secondary prophylaxis and in patients receiving chemotherapy for solid…
- Trial name
- VISTA (NCT02454530)
- Testing
- Nivestim®
- Where
- 92 sites in France
- Volunteers
- 1,160 people
- Sponsor
- Pfizer