Clinical trials: Pegfilgrastim
Advanced Cancer
A Dose-Escalation Study for Patients With Advanced Cancer
This study is being conducted to determine the safety of LY2523355 for the treatment of advanced and/or metastatic cancer (including Non-Hodgkin's lymphoma).
- Trial name
- NCT01214642
- Testing
- pegfilgrastim, LY2523355
- Where
- 2 sites in United States
- Volunteers
- 63 people
- Sponsor
- Eli Lilly and Company
Healthy Volunteers
Comparative Immunogenicity Study Comparing TPI-120 to Neulasta® in Healthy Adult Subjects
This study will compare treatment emergent incidence rate of ADA between TPI-120 and US licensed Neulasta in normal healthy adult subjects
- Trial name
- TPI-120 (NCT03202927)
- Testing
- PEGFILGRASTIM
- Where
- 2 sites in United States
- Volunteers
- 102 people, healthy volunteers welcome
- Sponsor
- Adello Biologics, LLC
Healthy Volunteers
Study Comparing TPI-120 and Neulasta Administered Through Subcutaneous Route in Healthy Adult Subjects
This is a single or up to 2 centers, double-blind, randomized, single-dose, two-way, crossover study comparing the Test (T) and Reference (R) products following subcutaneous administration.
- Trial name
- TPI-120 (NCT03206229)
- Testing
- PEG-rhG-CSF, Neulasta (PEG-rhG-CSF)
- Where
- United States
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Adello Biologics, LLC
Bone Pain in Stage I - III Breast Cancer
NOLAN: Naproxen or Loratadine and Neulasta
The primary objective of the study is to estimate the difference in bone pain between breast cancer patients receiving chemotherapy and pegfilgrastim and either no prophylactic intervention, prophylactic naproxen, or prophylactic…
- Trial name
- NOLAN (NCT01712009)
- Testing
- Naproxen, Loratadine, Pegfilgrastim
- Where
- 83 sites in United States
- Volunteers
- 600 people
- Sponsor
- Amgen
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.
Breast Cancer Female
Nanogen Pegcyte Clinical Study for the Prevention of CIN in Breast-cancer Patients.
Accelerated AC regimen-Doxorubicin 60 mg/m2,Cyclophosphamide 600 mg/m2 on day 1 \& day 14 of each cycle along with G-CSF support for up to 4 cycles, followed by Paclitaxel 175 mg/m2 in the next 4 cycles is the standard clinical…
- Trial name
- NCT03381417
- Testing
- pegcyte, Neulastim
- Where
- Vietnam
- Volunteers
- 128 people
- Sponsor
- Nanogen Pharmaceutical Biotechnology Joint Stock Company
Cancer, Colon Cancer
PAVES: Pegfilgrastim Anti-vascular Endothelial Growth Factor (VEGF) Evaluation Study
This is a phase 3, randomized, double-blind, placebo-controlled multi-center study evaluating the efficacy of pegfilgrastim to reduce the incidence of febrile neutropenia (FN) in patients with newly diagnosed, locally-advanced or…
- Conditions
- Cancer, Colon Cancer, Colorectal Cancer, Fever
- Trial name
- NCT00911170
- Testing
- Pegfilgrastim, Bevacizumab, Standard Chemotherapy
- Where
- 154 sites in United States, Australia and 15 more
- Volunteers
- 847 people
- Sponsor
- Amgen
Breast Cancer
Nanogen Pegfilgrastim (Pegcyte) PK/PD Clinical Study in Breast Cancer Patients
Breast cancer patients scheduled to receive myelosuppressive chemotherapy (AC regimen) will be enrolled in this study. Eligible patients receive single SC injection of pegcyte or neulastim 24 hours after administration of…
- Trial name
- NCT03376503
- Testing
- Pegfilgrastim
- Where
- Vietnam
- Volunteers
- 24 people
- Sponsor
- Nanogen Pharmaceutical Biotechnology Joint Stock Company
Bioequivalence
Study to Compare the Pharmacokinetics and Pharmacodynamics of 6 mg RGB-02 to 6 mg Neulasta
Single-centre, double-blind, randomised, two-period, two-way crossover study to investigate the pharmacokinetics and pharmacodynamics of RGB-02 as compared to Neulasta® administered as a single subcutaneous injection in healthy…
- Trial name
- NCT03146988
- Testing
- RGB-02 or Neulasta® (pegfilgrastim)
- Where
- United Kingdom
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- Gedeon Richter Plc.
Clinical Pharmacology
Pharmacokinetic and Pharmacodynamics of B12019 and Neulasta® in Healthy Subjects
Multi-centre, double-blind, randomised, 2-way cross-over study to investigate the PK and PD of B12019 as compared to Neulasta® administered as a single subcutaneous (s.c.) dose in healthy male subjects.
- Trial name
- NCT02629562
- Testing
- B12019 and Neulasta
- Where
- Germany
- Volunteers
- 172 people, healthy volunteers welcome
- Sponsor
- Cinfa Biotech
Breast Cancer
Trial to Compare the Efficacy and Safety of Pegfilgrastim Biosimilar in Subjects With High Risk Stage Breast Cancer Receiving Chemotherapy
This is a Phase III, randomised, assessor-blind, parallel group, multicentre trial. At least 180 adult subjects with high-risk Stage II or Stage III / IV breast cancer will be randomised (1:1) to receive either Eurofarma's…
- Trial name
- NCT02768714
- Testing
- Eurofarma's pegfilgrastim, Neulastim
- Sponsor
- Eurofarma Laboratorios S.A.
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
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
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
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
Neutropenia
Dose Finding Study of KRN125 (Pegfilgrastim) for Treatment of Neutropenic Patients
To assess the duration of severe neutropenia in cycle 1 of chemotherapy after treatment with a single injection of KRN125 or multiple daily injections of filgrastim.
- Trial name
- NCT00364468
- Testing
- pegfilgrastim
- Where
- 6 sites in Japan
- Volunteers
- 107 people
- Sponsor
- Kyowa Kirin Co., Ltd.
Neutropenia, Healthy
Pharmacokinetics and Pharmacodynamics Comparison Study Between Two Pegfilgrastim Formulations
This study will evaluate the pharmacokinetics (relative bioavailability) and pharmacodynamics, after single subcutaneous application, in healthy volunteers of both sexes, between pegfilgrastim formulation, produced by Eurofarma…
- Trial name
- NCT02589301
- Testing
- Pegfilgrastim
- Where
- Brazil
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Eurofarma Laboratorios S.A.
Non-Hodgkin's Lymphoma
An Expanded Access Program of Pegfilgrastim (Neulastim) in Participants With Non-Hodgkin's Lymphoma (NHL)
This study will assess the prophylactic effect of pegfilgrastim (Neulastim) on febrile and/or Grade IV neutropenia in participants receiving chemotherapy (CT) or immunochemotherapy (ICT) as first or second line treatment for NHL.
- Trial name
- NCT02782845
- Testing
- Chemotherapy, Immunochemotherapy, Pegfilgrastim
- Where
- 19 sites in Colombia, Mexico
- Volunteers
- 53 people
- Sponsor
- Hoffmann-La Roche
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.
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