Clinical trials: Pegfilgrastim
Healthy
Comparison of Quality and Quantity of M-PRP Cellular Content Filgrastim vs. Pegfilgrastim
The goal of this prospective, observational study is to compare the quality and quantity of the cellular content of platelet-rich plasma harvested after administering one of two cell-stimulating proteins, filgrastim and…
- Trial name
- M-PRP (NCT05573386)
- Testing
- Filgrastim, Pegfilgrastim
- Where
- United States
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Andrews Research & Education Foundation
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.
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
A Phase 1 Study to Assess the Immunogenicity of QL0605 Compared to US Neulasta in Healthy Subjects
The study was an assessor-blind, balanced, parallel, randomized, two-treatment, comparative immunogenicity study of multiple doses of subcutaneous (SC) Pegfilgrastim injection (6 mg/0.6 mL; Qilu Pharmaceutical Co., Ltd.
- Trial name
- NCT04651036
- Testing
- QL0605, US Neulasta
- Where
- 2 sites in Germany, United Kingdom
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Qilu Pharmaceutical Co., Ltd.
Sarcoma
Aranesp and Neulasta in Patients With Sarcoma Receiving Adriamycin and Ifosfamide
To determine the percentage of patients and number of cycles in which a packed red blood cell transfusion was administered due to anemia and in which antibiotics were administered due to neutropenic fever.
- Trial name
- NCT00283621
- Testing
- Aranesp (darbepoetin alfa), Neulasta (pegfilgrastim), Adriamycin
- Where
- United States
- Volunteers
- 51 people, healthy volunteers welcome
- Sponsor
- M.D. Anderson Cancer Center
Diffuse, Large B-Cell, Lymphoma
Phase II Study With Ga101-DHAP as Induction Therapy in Relapsed/Refractory DLBCL Patients
Aim of this trial is to assess the efficacy of new anti-CD20 antibody (GA101) in association with DHAP as induction therapy before high dose chemotherapy BEAM with ASCT in patients with relapsed/refractory DLBCL.
- Trial name
- GIOTTO (NCT02374424)
- Testing
- GA101_DHAP
- Where
- 10 sites in Italy
- Volunteers
- 29 people, healthy volunteers welcome
- Sponsor
- Fondazione Italiana Linfomi - ETS
Neutropenia
Biosimilarity Study of Subcutaneous Pegfilgrastim in Healthy Volunteers
This study will compare the pharmacokinetics and pharmacodynamics, after single subcutaneous application, in healthy men, between pegfilgrastim formulation, produced by Megalabs (test product) and Neulastim® (reference product)…
- Trial name
- NCT04873765
- Testing
- Pegfilgastrim Megalabs, Pegfilgastim Amgen
- Where
- Uruguay
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Megalabs
Healthy Volunteers
Immunogenicity and Pharmacodynamic of B12019 and Neulasta® in Healthy Subjects
Multiple-doses, randomised, double-blind, three-periods, two-sequences crossover study to assess the immunogenicity and pharmacodynamic comparability of a biosimilar pegfilgrastim (B12019) and the reference product Neulasta® in…
- Trial name
- NCT02912377
- Testing
- Neulasta, B12019
- Where
- Germany
- Volunteers
- 96 people, healthy volunteers welcome
- Sponsor
- Cinfa Biotech
PK in Healthy Volunteers
A Phase I PK/PD Study of PEG-MetHuG-CSF (P2203) in Healthy Volunteers
The goal of this study type: PK clinical trial is to evaluate the safety, tolerability, and pharmacokinetics/ pharmacodynamics of PEG-MetHuG-CSF (P2203) in Healthy Volunteers.
- Trial name
- P2203 phase I (NCT06698861)
- Testing
- PEG-MetHuG-CSF, Neulasta (Amgen)
- Where
- Taiwan
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- PharmaEssentia
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
Healthy
Pharmacokinetic/Pharmacodynamic (PK/PD) Study Evaluating Pegfilgrastim Hospira Compared to Neulasta (Amgen) in Healthy Volunteers
This study compared the pharmacokinetics, pharmacodynamics and the safety of Pegfilgrastim Hospira and Neulasta® following a single dose of 6 mg of each product administered subcutaneously in Treatment Periods 1 and 2…
- Trial name
- NCT00938678
- Testing
- Pegfilgrastim Hospira, Neulasta (Amgen)
- Where
- United Kingdom
- Volunteers
- 71 people, healthy volunteers welcome
- Sponsor
- Hospira, now a wholly owned subsidiary of Pfizer
Healthy
Study to Assess the Pharmacokinetic and Pharmacodynamic Bioequivalence of CHS-1701 With Neulasta
This is a randomized, single-blind, 3-period crossover study in healthy subjects to assess PK, PD, and safety (including immunogenicity) of a single 6mg subcutaneous injection of CHS-1701 (Coherus pegfligrastim) or 6mg SC dose of…
- Trial name
- NCT02650973
- Testing
- CHS-1701, Pegfilgrastim
- Where
- 4 sites in United States
- Volunteers
- 122 people, healthy volunteers welcome
- Sponsor
- Coherus Oncology, Inc.
Healthy
Safety and Immunogenicity of MSB11455 in Healthy Participants
The primary purpose of this study is to compare the immunogenicity and safety of MSB11455 and Neulasta in healthy adult participants.
- Trial name
- NCT03251339
- Testing
- MSB11455, US-Neulasta
- Where
- 2 sites in New Zealand
- Volunteers
- 336 people, healthy volunteers welcome
- Sponsor
- Fresenius Kabi SwissBioSim GmbH
Pharmacokinetics, Pharmacodynamics
PK, PD, Safety and Tolerability of Lipegfilgrastim in Healthy Japanese and Caucasian Participants
Cohorts of Japanese participants will be enrolled and treated prior to cohorts of Caucasian participants for the sake of matching.
- Trial name
- NCT02306915
- Testing
- lipegfilgrastim
- Where
- United Kingdom
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Merckle GmbH
Healthy
Safety and PK of HM10460A (HNK460) in Healthy Adult Japanese and Caucasian Subjects
Study Design Randomized, double-blind, placebo-controlled, escalating single-dose design. Six ascending dose cohorts In each cohorts, subjects will be randomized to receive a single dose of HM10460A, placebo (negative control)…
- Trial name
- NCT01037543
- Where
- United States
- Volunteers
- 84 people, healthy volunteers welcome
- Sponsor
- Hanmi Pharmaceutical Company Limited
Type 1 Diabetes
Neulasta in Type 1 Diabetes
The primary purpose of this study is to find out if giving a 12 week course of Neulasta (Pegylated granulocyte colony stimulating factor (GCSF)) to people with type 1 diabetes (T1D) is safe.
- Trial name
- NCT00662519
- Testing
- Neulasta (Pegylated), Mixed Meal Tolerance Test (MMTT), Blood test
- Where
- United States
- Volunteers
- 21 people, healthy volunteers welcome
- Sponsor
- University of Florida
RUNX1 Familial Platelet Disorder
Protocol Title: Safety and Feasibility of Autologous CD34+ Hematopoietic Stem Cells Mobilization and Apheresis in Participants With RUNX1 Familial Platelet Disorder
To evaluate the safety and feasibility of collecting hematopoietic stem cells (HSC) in participants with RUNX1-FPD.
- Trial name
- NCT06414889
- Testing
- G-CSF (filgrastim or biosimilar), Apheresis, Plerixafor
- Where
- United States
- Volunteers
- 4 people, healthy volunteers welcome
- Sponsor
- M.D. Anderson Cancer Center
Pharmacokinetic Bioequivalence Study in Human Healthy Volunteers
Comparative, Pharmacokinetic and Pharmacodynamic Study of Subcutaneous Injections of INTP5 of Intas Pharmaceuticals Ltd., India Against Neulasta of Amgen Inc., USA in Healthy, Adult Human Subjects.
The study was an assessor-blind, balanced, randomized, two-treatment, two-period, single-dose, two-way crossover, comparative, pharmacokinetic (PK) and pharmacodynamic (PD) study of subcutaneous (SC) Pegfilgrastim injection (6…
- Trial name
- NCT04014062
- Testing
- INTP5, US Neulasta
- Where
- India
- Volunteers
- 144 people, healthy volunteers welcome
- Sponsor
- Intas Pharmaceuticals, Ltd.
Immunity, Humoral
Assessing the Immunogenicity of 2 Subcutaneous Doses of CHS-1701 (Coherus Pegfilgrastim) With 2 Subcutaneous Doses Neulasta®
This is a randomized, double-blind, 2-period parallel study in healthy subjects to assess immunogenicity and safety of two sequential 6 mg subcutaneous (SC) injections of CHS-1701 compared with two sequential 6 mg SC injections…
- Trial name
- NCT02418104
- Testing
- CHS-1701, Pegfilgrastim (Neulasta)
- Where
- 4 sites in United States
- Volunteers
- 303 people, healthy volunteers welcome
- Sponsor
- Coherus Oncology, Inc.
Neutropenia
A Comparative Study to Evaluate the Effect of HSP-130, US-approved Neulasta and EU-approved Neulasta in Healthy Participants
This study is for healthy participants. This study tests single dose of the research drug HSP-130 against two existing approved drugs United States - approved Neulasta and European Union-approved Neulasta.
- Trial name
- NCT02629289
- Testing
- HSP-130, US-approved Neulasta, EU-approved Neulasta
- Where
- Australia
- Volunteers
- 153 people, healthy volunteers welcome
- Sponsor
- Pfizer