Clinical trials: G-CSF
Acute-On-Chronic Liver Failure, Alcoholic Hepatitis
A-TANGO Phase 2 Study
The purpose of this research is to know if a new combination of drugs (TAK-242 and G-CSF) in combination with standard therapy for acute-on-chronic liver failure (ACLF) is more effective than standard therapy for ACLF treatment…
- Conditions
- Acute-On-Chronic Liver Failure, Alcoholic Hepatitis, Liver Cirrhosis, Alcoholic
- Trial name
- A-TANGO (NCT06890039)
- Testing
- TAK-242, G-CSF (Filgrastim)
- Where
- United Kingdom
- Volunteers
- 78 people
- Sponsor
- Yaqrit Ltd
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.
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.
Infertility, Infertility,Female
The Role of Granulocyte Colony Stimulating Factor in Embryo Transfer Outcomes
The goal of this clinical trial is to test the effect of granulocyte colony-stimulating factor (G-CSF, A.K.A. Filgrastim) in infertility patients undergoing in vitro fertilization (IVF) treatment.
- Conditions
- Infertility, Infertility,Female, Infertility; Female, Nonimplantation, Infertility Unexplained
- Trial name
- NCT06174298
- Testing
- Granulocyte Colony-Stimulating Factor (Filgrastim), Standard Embryo Transfer Media
- Where
- Canada
- Volunteers
- 300 people
- Sponsor
- Newlife Fertility Centre
Hematopoietic Stem Cell Mobilization
Non-interventional, Long-term Safety Data Collection of Zarzio® / Filgrastim HEXAL® in Stem Cell Donors
Data collection on the safety and efficacy of Zarzio® / Filgrastim HEXAL® in adult healthy unrelated stem cell donors undergoing peripheral blood progenitor cell mobilization.
- Trial name
- SMART (NCT01766934)
- Where
- 2 sites in Germany
- Volunteers
- 245 people, healthy volunteers welcome
- Sponsor
- Sandoz
Lymphoma, Non-Hodgkin, Multiple Myeloma
Mobilization of Stem Cells With Plerixafor, Chemotherapy and G-CSF in Multiple Myeloma or Non-Hodgkin's Lymphoma Patients
Patients with multiple myeloma (MM) and non-Hodgkin's lymphoma (NHL) will be mobilized with chemotherapy and G-CSF plus plerixafor (AMD3100).
- Trial name
- NCT00322387
- Testing
- G-CSF and plerixafor
- Where
- 5 sites in United States
- Volunteers
- 40 people
- Sponsor
- Genzyme, a Sanofi Company
Healthy Male Subjects
Evaluation of Dose-response, Pharmacodynamic and Pharmacokinetic Bioequivalence of Filgrastim in Healthy Male Volunteers After Single and Multiple-dose Subcutaneous Administration of the Test Injectable Formulation BK0023 vs. Neupogen®
Study rationale: Bio-ker has developed the new formulation of filgrastim BK0023 with the same active content as Neupogen®. BK0023 is expected to have the same tolerability profile and clinical effects as Neupogen® in controlling…
- Trial name
- NCT01933971
- Testing
- Filgrastim test, Filgrastim reference
- Where
- Switzerland
- Volunteers
- 102 people, healthy volunteers welcome
- Sponsor
- Bio-ker S.r.l.
Acute Myeloid Leukemia
ALT-801-activated Natural Killer Cells After FLAG Induction for Acute Myeloid Leukemia
This is a single-center open-label phase I clinical trial of delivering haploidentical natural killer (NK) cells matured ex vivo with ALT-801 followed by intravenous infusions of ALT-801 in patients with relapsed/refractory Acute…
- Trial name
- NCT01478074
- Testing
- G-CSF, Cytarabine, Fludarabine
- Where
- United States
- Sponsor
- Altor BioScience
Prostate Cancer
Combination of Cabazitaxel With Prednisolone With Primary Prophylaxis With PEG-G-CSF in Treatment of Patients With Prostate Cancer
Primary Objective: To assess the tolerability of cabazitaxel 25 mg per body surface area (m^2) with primary prophylactic polyethylene glycol-granulocyte-colony stimulating factor (PEG-G-CSF) in terms of the incidence rate of…
- Trial name
- PEGAZUS (NCT02441894)
- Testing
- CABAZITAXEL XRP6258, PEG-G-CSF, Prednisolone
- Where
- 8 sites in Japan
- Volunteers
- 21 people
- Sponsor
- Sanofi
Non-Hodgkin's Lymphoma, Hodgkin's Disease
This is a Multi-center, Single Arm, Open Label Study Intended to Provide Expanded Access to Plerixafor for Patients With Non-Hodgkin's Lymphoma (NHL), Hodgkin's Disease (HD) or Multiple Myeloma (MM) Who Are to Receive Treatment With an Autologous Peripheral Stem Cell Transplant.
The purpose of this program is to provide expanded access to plerixafor for patients with NHL, HD, or MM who are to receive treatment with an autologous peripheral stem cell transplant.
- Conditions
- Non-Hodgkin's Lymphoma, Hodgkin's Disease, Multiple Myeloma
- Trial name
- EAP (NCT00720603)
- Testing
- Plerixafor
- Sponsor
- Genzyme, a Sanofi Company
Chemotherapy Induced Neutropenia
Phase III Study of DA-3031(PEG-G-CSF) in Chemotherapy-induced Neutropenia
This study is to determine whether once-per-cycle DA-3031(PEG-G-CSF) is not inferior to daily G-CSF in chemotherapy-induced neutropenia.
- Trial name
- PEG-G-CSF (NCT01674855)
- Testing
- PEG-G-CSF, G-CSF
- Where
- South Korea
- Volunteers
- 74 people
- Sponsor
- Dong-A ST Co., Ltd.
Stage IV (Metastatic) Breast Cancer
A Phase I/II Study of ABI-007 (Abraxane®, Nab®-Paclitaxel)and Vinorelbine in Patients With Stage IV (Metastatic) Breast Cancer
The purpose of this study is to: 1) determine the optimal tolerated dose of ABI-007 and vinorelbine, given concurrently on a weekly basis, in the absence of planned growth factor support with granulocyte colony-stimulating factor…
- Trial name
- NCT00140140
- Testing
- ABI-007, vinorelbine, Trastuzumab
- Where
- 2 sites in United States
- Volunteers
- 16 people
- Sponsor
- Celgene
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
Solid Tumour, Malignant Haematological Tumour
Nivestim™ in Treatment of Malignant Diseases
The purpose of this study is to observe the tolerability, safety and efficacy of preventative treatment using Nivestim™ in patients receiving cytotoxic chemotherapy for cancer.
- Conditions
- Solid Tumour, Malignant Haematological Tumour, Primary or Secondary Prophylactic Treatment
- Trial name
- NCT01627990
- Where
- 48 sites in Germany
- Volunteers
- 386 people
- Sponsor
- Hospira, now a wholly owned subsidiary of Pfizer
Lymphoma, Non-Hodgkin, Multiple Myeloma
Mobilization of Stem Cells With AMD3100 (Plerixafor) and G-CSF in Non-Hodgkin's Lymphoma and Multiple Myeloma Patients
This study evaluates the safety and efficacy of plerixafor given in addition to granulocyte-colony stimulating factor (G-CSF) for collection of peripheral blood stem cells (PBSCs) for autologous transplantation in patients with…
- Trial name
- NCT00322491
- Testing
- G-CSF Plus Plerixafor
- Where
- 8 sites in United States
- Volunteers
- 49 people
- Sponsor
- Genzyme, a Sanofi Company
Multiple Myeloma
A Phase III, Safety, Tolerability and Efficacy of Combination Treatment of BL-8040 and Granulocyte Colony Stimulating Factor (G-CSF) as Compared to Placebo and G-CSF for the Mobilization of Hematopoietic Stem Cells for Autologous Transplantation in Subjects With Multiple Myeloma (MM)
A total of 122 subjects were randomized into the study and investigated in the double-blind placebo-controlled setting to assess the efficacy and safety of G-CSF + BL-8040 as compared to G-CSF + placebo.
- Trial name
- GENESIS (NCT03246529)
- Testing
- BL-8040 1.25 mg/kg + G-CSF
- Where
- 18 sites in United States, Germany and 3 more
- Volunteers
- 180 people
- Sponsor
- BioLineRx, Ltd.
Bladder Cancer, Transitional Cell Cancer of the Renal Pelvis and Ureter
Combination Chemotherapy Plus Filgrastim in Treating Patients With Locally Recurrent or Advanced Urothelium Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Colony-stimulating factors such as filgrastim may increase the number of immune cells found in bone marrow or…
- Trial name
- NCT00005958
- Testing
- filgrastim, docetaxel, gemcitabine hydrochloride
- Where
- 12 sites in United States
- Sponsor
- Amgen
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
Multiple Myeloma, Non-Hodgkin Lymphoma
PD and Safety of TG-0054 Combined With G-CSF in Multiple Myeloma, Non-Hodgkin Lymphoma and Hodgkin Disease Patients
This is a phase II study to evaluate the efficacy and safety of TG-0054 combined with G-CSF in mobilizing hematopoietic stem cells in patients with multiple myeloma, non-Hodgkin lymphoma or Hodgkin disease.
- Conditions
- Multiple Myeloma, Non-Hodgkin Lymphoma, Hodgkin Disease
- Trial name
- NCT02104427
- Testing
- TG-0054 combined with G-CSF
- Where
- 2 sites in United States
- Volunteers
- 12 people
- Sponsor
- GPCR Therapeutics, Inc.
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.