Clinical trials: Granulocyte Colony-Stimulating Factor
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
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
Healthy Volunteers
Pharmacokinetic/Pharmacodynamic (PK/PD) Study Evaluating DA-3031 (PEG-G-CSF) to Filgrastim (Dong-A) in Healthy Volunteers
The safety, tolerability, and pharmacokinetics(PK)/pharmacodynamics (PD) of DA-3031 (PEG-G-CSF) following a single dose delivered by subcutaneous (SC) injection were investigated in healthy volunteers.
- Trial name
- NCT00959777
- Testing
- DA-3031, Filgrastim
- Where
- South Korea
- Sponsor
- Dong-A ST Co., Ltd.
Acute Myocardial Infarction, Acute Myocardial Ischemia
Study of Dutogliptin in Combination With Filgrastim in Post-Myocardial Infarction
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Safety and Efficacy Study of Dutogliptin in Combination with Filgrastim in Early Recovery Post-Myocardial Infarction
- Conditions
- Acute Myocardial Infarction, Acute Myocardial Ischemia, STEMI - ST Elevation Myocardial Infarction
- Trial name
- NCT03486080
- Testing
- Dutogliptin Tartrate, Filgrastim Injectable Product
- Where
- 12 sites in Austria, Belgium and 3 more
- Volunteers
- 49 people
- Sponsor
- Recardio, Inc.
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.
Coronavirus Disease 2019 (COVID-19) Pneumonia
Phase 3 Study to Evaluate Efficacy and Safety of Lenzilumab in Patients With COVID-19
The primary objective of this study is to assess whether the use of lenzilumab in addition to current standard of care can alleviate the immune-mediated cytokine release syndrome (CRS) and improve ventilator-free survival in…
- Trial name
- NCT04351152
- Testing
- Lenzilumab, Standard of Care
- Where
- 29 sites in United States, Brazil
- Volunteers
- 520 people
- Sponsor
- Humanigen, Inc.
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.
ST Elevation Myocardial Infarction
Dutogliptin in Co-administration With Filgrastim in Early Recovery Post-myocardial Infarction
The goal of this phase 3, randomized, double-blind, placebo-controlled clinical trial is to explore the safety and efficacy of dutogliptin administered subcutaneously (SC) in co-administration with filgrastim in adult patients…
- Trial name
- HEAL-MI (NCT05881382)
- Testing
- Dutogliptin + Filgrastim
- Volunteers
- 4,100 people
- Sponsor
- Recardio, Inc.
Infertility
Efficacy Study of Granulocyte-macrophage Colony Stimulating Factor (GM-CSF) for Use in Human IVF
This study is to assess whether addition of 2 ng/ml GM-CSF into a specific culture medium will increase the chance of a pregnancy after in vitro fertilisation.
- Trial name
- GM-CSF (NCT00565747)
- Testing
- Test culture, Control culture
- Where
- 14 sites in Denmark, Sweden
- Volunteers
- 1,332 people
- Sponsor
- Origio A/S
Neutropenia
A Phase II, Dose-finding Study of F-627 in Patients With Breast Cancer Receiving Myelotoxic Chemotherapy.
This was a randomized, open-label, active-controlled, dose-finding, phase II study to evaluate the efficacy and safety of 2 doses of F-627 compared to Filgrastim in women with breast cancer receiving myelotoxic chemotherapy.
- Trial name
- NCT02521441
- Testing
- F-627, Filgrastim
- Where
- China
- Volunteers
- 138 people
- Sponsor
- EVIVE Biotechnology
Neuroblastoma
Naxitamab for High-Risk Neuroblastoma Patients With Primary Refractory Disease or Incomplete Response to Salvage Treatment in Bone and/or Bone Marrow
Children and adults diagnosed with high-risk neuroblastoma patients with primary refractory disease or incomplete response to salvage treatment in bone and/or bone marrow will be treated for up to 101 weeks with naxitamab and…
- Trial name
- NCT03363373
- Testing
- GM-CSF + Naxitamab
- Where
- 20 sites in United States, Canada and 7 more
- Volunteers
- 122 people
- Sponsor
- Y-mAbs Therapeutics
Hodgkin's Disease
AMD3100 (Plerixafor) Added to a Mobilizing Regimen of Granulocyte-colony Stimulating Factor (G-CSF) to Increase the Number of Peripheral Blood Stem Cells (PBSCs) in Patients With Hodgkin's Disease
Participants with Hodgkin's Disease (HD) who have been treated with cyto-reductive chemotherapy, who are to undergo autologous stem cell transplantation, and who meet the inclusion/exclusion criteria are eligible to enter this…
- Trial name
- NCT00396201
- Testing
- G-CSF Plus Plerixafor
- Where
- United States
- Volunteers
- 22 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
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
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
Immunogenicity Assessment of Peg-filgrastim vs. Neulasta® as Adjunct to Chemotherapy in Patients With Breast Cancer
The purpose of this study is to compare the immunogenicity of Peg-filgrastim versus Neulasta® as an adjunct to chemotherapy in patients with breast cancer
- Trial name
- NCT03511378
- Testing
- Lupin's Pegfilgrastim, Neulasta®
- Where
- 17 sites in India
- Volunteers
- 138 people
- Sponsor
- Lupin Ltd.
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
Acquired Primary Autoimmune and Idiopathic Chronic Neutropenia Disorders, Chronic Neutropenia
A Study to Investigate the Safety and Tolerability of Granulocyte-colony Stimulating Factor (G-CSF) Dosage Reduction in Mavorixafor-treated Participants With Acquired Primary Autoimmune and Idiopathic Chronic Neutropenia Disorders
The purpose of this study is to evaluate the safety and tolerability of G-CSF dosage reduction with mavorixafor in participants with autoimmune neutropenia (AIN) and chronic idiopathic neutropenia (CIN) disorders as assessed by…
- Conditions
- Acquired Primary Autoimmune and Idiopathic Chronic Neutropenia Disorders, Chronic Neutropenia, Autoimmune Neutropenia, Chronic Idiopathic Neutropenia
- Trial name
- NCT07902830
- Testing
- Mavorixafor
- Volunteers
- 40 people
- Sponsor
- X4 Pharmaceuticals
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