Clinical trials: Granulocyte Colony-Stimulating Factor
- Condition Granulocyte Colony-Stimulating Factor
- Funder type Industry (pharma, biotech, devices)
- Has posted results yes
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
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
COVID-19
A Study to Assess the Efficacy and Safety of Gimsilumab in Subjects With Lung Injury or Acute Respiratory Distress Syndrome Secondary to COVID-19 (BREATHE)
Study KIN-1901-2001 is a multi-center, adaptive, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of gimsilumab in subjects with lung injury or acute respiratory distress syndrome (ARDS)…
- Trial name
- NCT04351243
- Testing
- Gimsilumab
- Where
- 33 sites in United States
- Volunteers
- 227 people
- Sponsor
- Kinevant Sciences GmbH
Neuroblastoma
ch14.18 Pharmacokinetic Study in High-risk Neuroblastoma
The purpose of this study is to compare the pharmacokinetics (blood levels) and safety of chimeric (ch) 14.18 manufactured by two independent drug makers (United Therapeutics [UTC] or the National Cancer Institute [NCI]).
- Trial name
- NCT01592045
- Testing
- ch14.18 -NCI, ch14.18-UTC, Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF)
- Where
- 13 sites in United States
- Volunteers
- 28 people
- Sponsor
- United Therapeutics
Arthritis, Rheumatoid
Lipopolysaccharide (LPS) or Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) Challenge Study on Healthy Subjects
This exploratory study aims to assess exposure of healthy subjects to systemic challenge with either LPS or GM-CSF. This will be done by measuring inflammatory mediators and cellular activation markers both in circulation and in…
- Trial name
- NCT03306589
- Testing
- Cantharidin, Lipopolysaccharide, Granulocyte-Macrophage Colony-Stimulating Factor
- Where
- United Kingdom
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Neuroblastoma Recurrent
Naxitamab and GM-CSF in Combination With IT in Patients With High-Risk Neuroblastoma
An International, Single-Arm, Multicenter Phase 2 Trial.
- Trial name
- NCT04560166
- Testing
- Naxitamab and GM-CSF in combination with irinotecan and temozolomide
- Where
- 3 sites in Hong Kong, South Korea
- Volunteers
- 2 people
- Sponsor
- Y-mAbs Therapeutics
Leucocytosis
Clinical Trial to Evaluate Pharmacokinetics, Pharmacodynamics and Safety of Leucostim® Compared to Neupogen®
BCD-002-1 is 1 phase clinical trial to evaluate pharmacokinetics, pharmacodynamics and safety of single-injection of Leucostim® to healthy volunteers compared to Neupogen®
- Trial name
- NCT02762799
- Testing
- Leucostim®, Neupogen®
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Biocad
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.
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
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
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.
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
Arthritis, Rheumatoid
Mechanistic Study of GSK3196165 Plus Methotrexate (MTX) in Subjects With Active Rheumatoid Arthritis
This study is designed to explore the activity of granulocyte-macrophage colony stimulating factor (GM-CSF) signaling pathway in subjects with rheumatoid arthritis (RA), the potential impact of inhibition of this axis by…
- Trial name
- NCT02799472
- Testing
- GSK3196165, MTX, Folic (or folinic) acid
- Where
- 16 sites in United States, Germany and 1 more
- Volunteers
- 39 people
- Sponsor
- GlaxoSmithKline
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.
Healthy Participants
Study of the Effect of a 5-Day Regimen of Study Drug on Peripheral Stem Cell Mobilization in Healthy Participants
A multi-center, open-label, single-arm clinical study to assess effects of a 5-day regimen of 10 micrograms per kilogram (mcg/kg) of tbo-filgrastim administered subcutaneously daily on the mobilization of cluster of…
- Trial name
- GRANIX (NCT03029000)
- Testing
- Tbo-filgrastim
- Where
- 9 sites in United States
- Volunteers
- 1 people, healthy volunteers welcome
- Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
Chemotherapy Associated Neutropenia, Breast Cancer
Phase III Study Comparing the Efficacy and Safety of EP2006 and Filgrastim
The study will assess the efficacy of EP2006 compared to Filgrastim with respect to the mean duration of severe neutropenia during treatment with myelosuppressive chemotherapy in breast cancer patients.
- Trial name
- PIONEER (NCT01519700)
- Testing
- EP2006, Filgrastim
- Where
- 26 sites in Czechia, Hungary and 4 more
- Volunteers
- 218 people
- Sponsor
- Sandoz
Postmenopausal Symptoms
A Study of the Safety and Effect of Repeated Administration of G-CSF on Hot Flashes in Postmenopausal Women
The purpose of this study is to assess the efficacy and safety of repeated administration of G-CSF for the treatment of hot flashes and vasomotor symptoms in women with naturally-occurring or surgically induced menopause.
- Trial name
- NCT03640754
- Testing
- G-CSF
- Where
- 2 sites in United States
- Volunteers
- 61 people
- Sponsor
- MenoGeniX, Inc.
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