Clinical trials: G-CSF
Non-Hodgkin Lymphoma, Hodgkin Disease
The Effect of Rituximab on Mobilization With AMD3100 (Plerixafor) Plus G-CSF in Patients With Relapsed or Refractory Non-Hodgkin Lymphoma (NHL) or Hodgkin Disease (HD)
Participants with non-Hodgkin lymphoma (NHL) or Hodgkin disease (HD) will be assigned to one of 2 arms based on the immunophenotype of their lymphoma.
- Trial name
- NCT00444912
- Testing
- G-CSF plus plerixafor, rituximab
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Genzyme, a Sanofi Company
Neutropenia (Low White Blood Cell Count)
A Study to Compare the Pharmacokinetics, Pharmacodynamics, Immunogenicity, Safety and Tolerability of Filgrastim Biosimilar and Neupogen Reference Product in Healthy Volunteers
The goal of this clinical trial is to assess the pharmacokinetic similarity of Biofilgragen, a filgrastim biosimilar, compared with EU-authorized Neupogen after single subcutaneous doses in healthy adult volunteers.
- Trial name
- FIL-BIO-IMG (NCT07877467)
- Testing
- Biofilgragen, Neupogen (filgrastim)
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- BioGeneric Pharma
Multiple Myeloma
Mobilization of Stem Cells With AMD3100 (Plerixafor) in Multiple Myeloma Patients
The purpose of this study is to determine whether the combination of AMD3100 (plerixafor) and granulocyte colony-stimulating factor (G-CSF, generic name of filgrastim) is better than G-CSF alone to mobilize and collect the…
- Trial name
- NCT00103662
- Testing
- Granulocyte colony-stimulating factor plus plerixafor
- Where
- 39 sites in United States, Canada and 1 more
- Volunteers
- 302 people
- Sponsor
- Genzyme, a Sanofi Company
Autologous Stem Cell Transplantation
AMD3100 (Plerixafor) With G-CSF in Poor Mobilizing Adult Patients Who Previously Failed Hematopoietic Stem Cell (HSC) Collection/Attempts
This study evaluates the safety, efficacy, and pharmacokinetics (PK) of plerixafor given in addition to granulocyte-colony stimulating factor (G-CSF) for collection of peripheral blood stem cells (PBSCs) for autologous…
- Trial name
- NCT00396331
- Testing
- G-CSF plus plerixafor
- Where
- 8 sites in United States
- Volunteers
- 100 people
- Sponsor
- Genzyme, a Sanofi Company
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.
Neutropenia, Breast Cancer
SPI-2012 vs Pegfilgrastim in Management of Neutropenia in Breast Cancer Participants With Docetaxel and Cyclophosphamide
The purpose of this study is to compare the efficacy of SPI-2012 versus pegfilgrastim in participants with early-stage breast cancer receiving docetaxel and cyclophosphamide (TC) as measured by the duration of severe neutropenia…
- Trial name
- NCT02953340
- Testing
- SPI-2012, Pegfilgrastim, Docetaxel
- Where
- 74 sites in United States, Canada and 4 more
- Volunteers
- 237 people
- Sponsor
- Spectrum Pharmaceuticals, Inc
Breast Cancer
Treatment for Elderly Patients With High Risk Breast Cancer
This open-label, multicenter study explored primary and secondary prophylaxis treatment with a single, fixed-dose, subcutaneous (SC) injection of pegfilgrastim in elderly subjects with high-risk breast cancer receiving…
- Trial name
- NCT00117910
- Testing
- pegfilgrastim
- Sponsor
- Amgen
Diabetic Foot, Critical Limb Ischemia
A Clinical Trial on Diabetic Foot Using Peripheral Blood Derived Stem Cells for Treating Critical Limb Ischemia
The purpose of this study is to determine whether the method (implanting stem cells derived from peripheral blood after G-CSF mobilization) of treatment is safe and effective in the management of diabetic foot ischemia, the…
- Conditions
- Diabetic Foot, Critical Limb Ischemia, Leg Ulcers
- Trial name
- NCT00922389
- Testing
- will receive G-CSF and peripheral blood derived mononuclear cells, G-CSF, Standard Therapy
- Where
- India
- Volunteers
- 36 people
- Sponsor
- Beike Biotech India Pvt.ltd
Infertility
Impact of Follicular and Blood G-CSF During a Natural Cycle of IVF
Recently, scientists look into G-CSF (Granulocyte - Colony Stimulatin Factor). The use of this molecule is increasing in reproduction pathology.
- Trial name
- GCSFnat (NCT01668225)
- Testing
- Blood test
- Where
- Canada
- Volunteers
- 152 people
- Sponsor
- Clinique Ovo
HIV Infections, Cytopenias
A Randomized, Controlled, Multicenter Trial of Filgrastim (Recombinant-Methionyl Human Granulocyte Colony Stimulating Factor; G-CSF) for the Prevention of Grade 4 Neutropenia in Patients With HIV Infection.
To determine, in HIV-infected patients, the efficacy of filgrastim ( recombinant-methionyl human granulocyte-colony stimulating factor; G-CSF ) in preventing grade 4 neutropenia, i.e., absolute neutrophil count (ANC) < 500…
- Trial name
- NCT00002126
- Testing
- Filgrastim
- Where
- 22 sites in United States, Canada
- Volunteers
- 250 people
- Sponsor
- Amgen
Prostate Cancer
Mitoxantrone and G-CSF in Treating Patients With Metastatic Prostate Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with G-CSF may make tumor cells more sensitive to the chemotherapy drug and may kill…
- Trial name
- NCT00003183
- Testing
- filgrastim, mitoxantrone hydrochloride
- Where
- 2 sites in United States
- Volunteers
- 64 people
- Sponsor
- Hope Cancer Institute, Inc.
Healthy
Evaluation of Pharmacokinetic/Pharmacodynamic Properties and Safety of Leucostim® Compared to Neupogen® in Healthy Adult Volunteers
A Randomized, Open-label, Two-way Crossover, Open-label Clinical Trial to Compare Pharmacokinetic/Pharmacodynamic Properties and Safety after Subcutaneous Administration of Leucostim® and Neupogen® in Healthy Adult Volunteers
- Trial name
- NCT02725086
- Testing
- Leucostim®, Neupogen®
- Where
- South Korea
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Dong-A ST Co., Ltd.
Healthy Volunteers
A Study in Healthy Volunteers to Assess Immune Response to Multiple Injections of Filgrastim Hospira or Neupogen Reference Product.
This study compares the potential immunogenicity of two filgrastims, the proposed biosimilar Filgrastim Hospira (US) and the US-approved Neupogen reference product.
- Trial name
- NCT02923791
- Testing
- Filgrastim Hospira, US-Approved Neupogen
- Where
- 3 sites in United States
- Volunteers
- 256 people, healthy volunteers welcome
- Sponsor
- Pfizer
Chemotherapy Patients
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of YPEG-Filgrastim in Chemotherapy Patients
This study will assess the safety, tolerability, pharmacokinetics, pharmacodynamics of a single-dose of YPEG-Filgrastim in cancer patients receiving chemotherapy, and will establish dose-response relationships between…
- Trial name
- Filgrastim (NCT01238562)
- Testing
- YPEG-Filgrastim
- Where
- China
- Volunteers
- 30 people
- Sponsor
- Xiamen Amoytop Biotech Co., Ltd.
Peripheral Blood Stem Cell Transplantation
KRN125 for Mobilization of Hematopoietic Stem Cells
Data collection to evaluate safety and effect of hematopoietic stem cell mobilization into the peripheral blood after a single subcutaneous (SC) dose of KRN125(Pegfilgrastim)in healthy adults.
- Trial name
- NCT03993639
- Testing
- Pegfilgrastim
- Where
- Japan
- Volunteers
- 35 people, healthy volunteers welcome
- Sponsor
- Kyowa Kirin Co., Ltd.
Healthy Volunteers
Pharmacokinetic / Pharmacodynamic Study Comparing MYL-1401H, EU-sourced Neulasta and US-licensed Neulasta
This is a single center, double-blind, randomized, comparative pharmacokinetic and pharmacodynamic study of MYL-1401H and Neulasta (from EU and US source) in Normal Healthy Volunteers.
- Trial name
- NCT02479646
- Testing
- MYL-1401H, EU-Neulasta, US-Neulasta
- Where
- Netherlands
- Volunteers
- 218 people, healthy volunteers welcome
- Sponsor
- Mylan Inc.
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, 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
Miscellaneous Peripheral Blood Cell Abnormalities
Safety and Efficacy of TXA127 and Neupogen to Increase Peripheral Blood Stem Cells (PBSCs)
This is a Phase I Study to be conducted in 18 healthy volunteers. Each will receive daily injections for 5 days of TXA127 alone, or Neupogen alone, or TXA127 plus Neupogen together.
- Trial name
- NCT01543971
- Testing
- TXA127, Neupogen (filgrastim)
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Tarix Pharmaceuticals
Pharmacokinetics
A Comparative, Crossover, Pharmacokinetic, Pharmacodynamic and Safety Study of Three Forms of PEG-G-CSF in Normal Healthy Volunteers
This is a comparative pharmacokinetic, pharmacodynamic and safety study in healthy volunteers with three forms of pegylated granulocyte colony stimulating factors.
- Trial name
- NCT02205320
- Testing
- DRL_PG, Pegfilgrastim Form A, Pegfilgrastim Form B
- Where
- United States
- Volunteers
- 192 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited