Clinical trials: G-CSF
Healthy Subjects
Evaluation of Pharmacokinetic and Pharmacodynamic Parameters of Filgrastim (G-CSF)Produced by Blausiegel Indústria e Comércio Ltda. Compared to Granulokine Produced by Produtos Roche Químicos e Farmacêuticos S/A.
The primary aim of this study is to compare the pharmacokinetic and pharmacodynamic effects of two commercial preparations of filgrastim (T and C), after single dose via subcutaneous or intravenous administration at a…
- Trial name
- NCT01549301
- Testing
- Filgrastim
- Where
- Brazil
- Volunteers
- 128 people, healthy volunteers welcome
- Sponsor
- Azidus Brasil
Breast Cancer, Neutropenia
Safety and Efficacy Study of GCSF Therapy to Treat Patients at High Risk for Chemotherapy Induced Severe Neutropenia
The overall purpose of this study is to assess the dose response, efficacy, and safety of three different dose levels of AVI 014 (granulocyte colony-stimulating factor [G-CSF]) in breast cancer patients at high (>20%) risk for…
- Trial name
- NCT00497809
- Testing
- AVI-014 versus Filgrastim
- Where
- 31 sites in United States, India
- Volunteers
- 189 people
- Sponsor
- AviGenics
Chemotherapy-induced Neutropenia
Balugrastim (Neugranin) in Breast Cancer Participants Receiving Doxorubicin/Docetaxel
Determination of the effect of balugrastim on the duration and severity of severe neutropenia.
- Trial name
- NEUGR-002 (NCT00837265)
- Testing
- Balugrastim, Pegfilgrastim, Chemotherapy Regimen
- Volunteers
- 334 people
- Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
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.
Lymphoma, Non-Hodgkin
Mobilization of Stem Cells With AMD3100 (Plerixafor) in Non-Hodgkin's Lymphoma Patients
The purpose of this study is to determine whether the combination of AMD3100 (plerixafor) and granulocyte colony-stimulating factor (G-CSF or generic name filgrastim) is better than G-CSF alone to mobilize and collect the optimal…
- Trial name
- NCT00103610
- Testing
- Granulocyte colony-stimulating factor plus plerixafor
- Where
- 32 sites in United States, Canada
- Volunteers
- 298 people
- Sponsor
- Genzyme, a Sanofi Company
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
Normal PBPC Donors
Open-Label Trial of Peripheral Blood Progenitor Cell (PBPC) Mobilization by Filgrastim in Normal Donors
The purpose of this study is to clinically evaluate the spleen during PBPC mobilization by filgrastim in normal donors.
- Trial name
- NCT00115128
- Testing
- filgrastim
- Volunteers
- 309 people
- Sponsor
- Amgen
Multiple Myeloma
An Exploratory Safety Study to Investigate the Extent of Tumor Cell Mobilization (TCM) After Use of G-CSF Alone or G-CSF Plus Plerixafor in Multiple Myeloma (MM) Patients Who May be Poor Mobilizers of Stem Cells
The primary objective of this study is to evaluate tumor cell mobilization (TCM) with non-pegylated G-CSF alone compared with non-pegylated G-CSF plus plerixafor in patients with multiple myeloma (MM) who are potentially poor…
- Trial name
- NCT01753453
- Testing
- Plerixafor, Granulocyte-colony stimulating factor (G-CSF)
- Where
- 5 sites in Belgium, Estonia and 2 more
- Volunteers
- 23 people
- Sponsor
- Sanofi
Lymphoma (Non-Hodgkin's Lymphoma), Hodgkin's Disease or Multiple Myeloma
A Multi-centre, Open Label, Single-arm Study Intended to Further Investigate the Safety and Efficacy of Plerixafor as a Front-line Mobilisation Agent in Combination With G-CSF in Patients With Lymphoma or MM (Multiple Myeloma).
This is a research study intended to further investigate the safety and efficacy of plerixafor in patients with NHL, HD, or MM. Patients who have previously failed stem cell mobilisation attempts or who have previously received…
- Conditions
- Lymphoma (Non-Hodgkin's Lymphoma), Hodgkin's Disease or Multiple Myeloma, Front Line Mobilization, Transplantation
- Trial name
- PREDICT (NCT00838357)
- Testing
- Generic = Plerixafor
- Where
- 26 sites in France, Germany and 5 more
- Volunteers
- 118 people
- Sponsor
- Genzyme, a Sanofi Company
Severe Chronic Neutropenia
Immunogenicity, Safety, and Efficacy of Zarzio®/Filgrastim HEXAL® in Patients With Severe Chronic Neutropenia
Purpose of the study is to investigate the safety, immunogenicity and the efficacy of Zarzio®/Filgrastim HEXAL® under chronic administration for 12 months in patients diagnosed with severe chronic neutropenia.
- Trial name
- NCT01859637
- Testing
- Filgrastim
- Where
- 2 sites in Germany, Sweden
- Volunteers
- 6 people
- Sponsor
- Sandoz
Neutropenia
A Study to Evaluate 5 μg/kg Tbo-filgrastim in Infants, Children and Adolescents With Solid Tumors Without Bone Marrow Involvement
The purpose of the study is to evaluate the safety, pharmacokinetics, pharmacodynamics, and efficacy of daily subcutaneous administration of 5 μg/kg tbo-filgrastim in infants, children and adolescents with solid tumors without…
- Trial name
- NCT02190721
- Testing
- tbo-filgrastim
- Where
- 33 sites in United States, Bulgaria and 6 more
- Volunteers
- 50 people
- Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
Hematopoietic Stem Cell Transplantation
NOX-A12 Multiple Ascending Dose Study in Healthy Volunteers
This is the second clinical study of NOX-A12. This study intends to provide information on the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of repeated intravenous doses of NOX-A12 (2.0 and 4.0 mg/kg/d)…
- Trial name
- SNOXA12C101 (NCT01194934)
- Testing
- NOX-A12, Filgrastim, NOX-A12 in combination with Filgrastim
- Where
- Germany
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- TME Pharma AG
Multiple Myeloma
Plerixafor Plus Granulocyte Colony-stimulating Factor (G-CSF) For Mobilization And Collection Of Peripheral Hematopoietic Stem Cells In Japanese Participants With Multiple Myeloma
Primary Objective: To determine if Multi Myeloma (MM) patients mobilized with granulocyte colony-stimulating factor (G-CSF) plus plerixafor 240 μg/kg are more likely to achieve a target number of greater than or equal to 6 x 10^6…
- Trial name
- NCT02221479
- Testing
- plerixafor GZ316455, Filgrastim
- Where
- 5 sites in Japan
- Volunteers
- 14 people
- Sponsor
- Genzyme, a Sanofi Company
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.
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
Infertility
Diafert for Embryo Selection and Fertility Improvement (DESTINy)
Prospective, single-center, single-blind, randomized, controlled, two-arm, interventional study.
- Trial name
- DESTINy (NCT02593513)
- Testing
- Daifert, Control Group
- Where
- Hungary
- Volunteers
- 108 people
- Sponsor
- Forest Laboratories
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.
Non-Hodgkin's Lymphoma (NHL), Chronic Lymphocytic Leukemia (CLL)
Tumor Registry of Lymphatic Neoplasia
The purpose of this registry is to record information on therapy reality of malignant lymphatic systemic diseases by office-based haematologists in Germany.
- Conditions
- Non-Hodgkin's Lymphoma (NHL), Chronic Lymphocytic Leukemia (CLL), Multiple Myeloma (MM)
- Trial name
- TLN-Registry (NCT00889798)
- Volunteers
- 3,795 people
- Sponsor
- iOMEDICO AG
HIV Infections, Cytopenias
A Study of Granulocyte Colony-Stimulating Factor Plus Recombinant Erythropoietin Plus Zidovudine in Patients With AIDS or AIDS-Related Complex
To evaluate the safety, tolerance and biological activity of filgrastim (granulocyte colony-stimulating factor; G-CSF) given by daily subcutaneous (SC) injection prior to and concomitantly with erythropoietin (EPO) and zidovudine…
- Trial name
- NCT00002281
- Testing
- Filgrastim, Epoetin alfa, Zidovudine
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- Amgen
Chemotherapy-induced Neutropenia
Dose-finding Study of Empegfilgrastim for Neutropenia Prophylaxis in Patients With Breast Cancer
The purpose of the study is to compare safety and efficacy of a single dose of empegfilgrastimt a dose of 3 or 6 mg versus daily administration of filgrastim at a dose of 5 μg/kg/day.
- Trial name
- NCT01569087
- Testing
- empegfilrastim, filgrastim
- Where
- 5 sites in Russia
- Volunteers
- 60 people
- Sponsor
- Biocad