Clinical trials: Neutropenia
Neutropenia
Safety and Pharmacokinetics of Intravenous and Oral Posaconazole in Immunocompromised Children (MK-5592-097)
This study aims to evaluate the pharmacokinetics of posaconazole (POS) administered intravenously (IV) or orally to immunocompromised pediatric participants.
- Trial name
- NCT02452034
- Testing
- Posaconazole IV solution, Posaconazole powder for oral suspension
- Volunteers
- 118 people
- Sponsor
- Merck Sharp & Dohme LLC
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, Neutropenia
Study to Compare the Efficacy and Safety of F-627 and GRAN®
A Phase III, Multi-Center, Randomized, Open-Label, Active-Controlled Trial to Compare the Efficacy and Safety of Recombinant Human Granulocyte Colony Stimulating Factor-Fc Fusion Protein (F-627) and Recombinant Human Granulocyte…
- Trial name
- NCT04174599
- Testing
- F-627, GRAN®
- Where
- China
- Volunteers
- 242 people
- Sponsor
- EVIVE Biotechnology
Fever, Neutropenia
A Study of Ceftobiprole in Patients With Fever and Neutropenia.
The purpose of this study is to assess the safety and efficacy of ceftobiprole versus a comparator in patients with fever and neutropenia
- Conditions
- Fever, Neutropenia, Gram-positive Bacterial Infections, Pseudomonas Infection
- Trial name
- NCT00529282
- Testing
- Ceftobiprole Medocaril, Cefepime with or without vancomycin
- Volunteers
- 2 people
- Sponsor
- Basilea Pharmaceutica
Advanced Metastatic (Stage IV) Colorectal Cancer
A Trial of PledOx + FOLFOX6 Compared to Placebo + FOLFOX6 in Patients With Metastatic Colorectal Cancer
The present trial is designed to determine whether pre-treatment with PledOx lowers the frequency and severity of side effects from FOLFOX6 administration in patients with metastatic colorectal cancer.
- Trial name
- PLIANT (NCT01619423)
- Testing
- PledOx (2 µmol/kg), PledOx (5 µmol/kg), PledOx (10 µmol/kg)
- Where
- 33 sites in United States, Bulgaria and 6 more
- Volunteers
- 186 people
- Sponsor
- Egetis Therapeutics AB (publ)
Neutropenia, Breast Cancer
SPI-2012 vs Pegfilgrastim in the Management of Neutropenia in Participants With Breast Cancer With Docetaxel and Cyclophosphamide (ADVANCE)
The purpose of this study was to compare the efficacy of a single dose of SPI-2012 versus pegfilgrastim in participants with early-stage breast cancer receiving docetaxel and cyclophosphamide (TC), as measured by the duration of…
- Trial name
- ADVANCE (NCT02643420)
- Testing
- SPI-2012, Pegfilgrastim, Docetaxel
- Where
- 81 sites in United States, Canada and 1 more
- Volunteers
- 406 people
- Sponsor
- Spectrum Pharmaceuticals, Inc
Fungal Infections
A Study of the Safety, Tolerance, and Pharmacokinetics of Oral Posaconazole in Immunocompromised Children (P03579)
The purpose of this dose-escalation study is to evaluate the pharmacokinetics, safety, and tolerability of oral posaconazole in immunocompromised children with neutropenia or expected neutropenia.
- Trial name
- NCT01716234
- Testing
- Posaconazole 12 mg/kg/day BID, Posaconazole 18 mg/kg/day BID, Posaconazole 18 mg/kg/day TID
- Volunteers
- 142 people
- Sponsor
- Merck Sharp & Dohme LLC
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
Fungal Infection, Acute Myelogenous Leukemia
Oral Posaconazole in High Risk Patients With Gastrointestinal Dysfunction (Study P05115)
The purpose of this study is: to explore the potential for different dosing strategies of posaconazole oral suspension (POS) to increase plasma levels and to profile the pharmacokinetics of these dosing strategies in patients…
- Conditions
- Fungal Infection, Acute Myelogenous Leukemia, Neutropenia
- Trial name
- NCT00686543
- Testing
- Posaconazole
- Volunteers
- 75 people
- Sponsor
- Merck Sharp & Dohme LLC
Breast Cancer, Neutropenia
Neulasta-controlled Trial of F-627 in Women With Breast Cancer Receiving Myelotoxic Chemotherapy
This is a randomized, multi-center, single dose, open-label and Neulasta controlled phase 3 study to evaluate the efficacy and safety of F-627 in women with Stage I - III invasive breast cancer receiving chemotherapy treatment.
- Trial name
- NCT03252431
- Testing
- F-627, Neulasta
- Where
- United States
- Volunteers
- 393 people
- Sponsor
- EVIVE Biotechnology
Possible Fungal Infection
Immediate vs. Deferred Empirical Antifungal Treatment With Voriconazole In Neutropenic Patients
A well-known side-effect of cytostatics (drugs against malignancies) is a decrease in the number of white blood cells, especially of the so-called neutrophil granulocytes, which are very important for the defense against…
- Trial name
- IDEA (NCT00150345)
- Testing
- voriconazole (Vfend)
- Where
- 28 sites in Germany
- Volunteers
- 147 people
- Sponsor
- Pfizer
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
Breast Cancer, Neutropenia
Dose-Finding Trial of F-627 in Women With Breast Cancer Receiving Myelotoxic Chemotherapy
This is a randomized open label dose finding study to evaluate the efficacy and safety of F-627 on women with Stage I-IV breast cancer receiving chemotherapy treatment.
- Trial name
- NCT01648322
- Testing
- F-627, Neulasta® (pegfilgrastim)
- Where
- United States
- Volunteers
- 232 people
- Sponsor
- EVIVE Biotechnology
Breast Cancer, Neutropenia
Placebo-controlled Trial of F-627 in Women With Breast Cancer Receiving Myelotoxic Chemotherapy
This is a randomized, double-blind and placebo controlled phase 3 study to evaluate the efficacy and safety of F-627 in women with stage II-IV breast cancer receiving chemotherapy treatment.
- Trial name
- NCT02872103
- Testing
- F-627
- Where
- United States
- Volunteers
- 122 people
- Sponsor
- EVIVE Biotechnology
Healthy Volunteers
Pharmacokinetic Comparability Study in Healthy Participants - PF-06881894 On-Body Injector Relative to Prefilled Syringe
This will be an open-label, randomized, 2-treatment, 2-period, crossover single-dose study in approximately 134 healthy adult participants.
- Trial name
- NCT05194579
- Testing
- PF-06881894 by on-body injector, PF-06881894 by prefilled syringe
- Where
- 4 sites in United States
- Volunteers
- 141 people, healthy volunteers welcome
- Sponsor
- Pfizer
Chemotherapy-induced Neutropenia
Plinabulin vs. Pegfilgrastim in Patients With Solid Tumors Receiving Docetaxel Myelosuppressive Chemotherapy Phase 2
To assess the duration of severe neutropenia (DSN) in treatment Cycle 1 in patients treated with docetaxel (75 mg/m2) + plinabulin (5, 10, or 20 mg/m2) or with docetaxel (75 mg/m2) + pegfilgrastim (6 mg).
- Trial name
- NCT04345900
- Testing
- Plinabulin, Pegfilgrastim
- Where
- 19 sites in United States, China and 2 more
- Volunteers
- 55 people
- Sponsor
- BeyondSpring Pharmaceuticals Inc.
Chemotherapy-Induced Neutropenia
Use of Biosimilar Nivestim® to Prevent Chemo-induced Neutropenia. Real Life Study
The aim of this study is to describe in real-life conditions the determinants of use of GCSF (Granulocyte Colony-Stimulating Factor) Nivestim® in primary or secondary prophylaxis and in patients receiving chemotherapy for solid…
- Trial name
- VISTA (NCT02454530)
- Testing
- Nivestim®
- Where
- 92 sites in France
- Volunteers
- 1,160 people
- Sponsor
- Pfizer
Hematologic Neoplasms, Neutropenia
The Relationship of Defeverscence and Itraconazole Plasma Level Study in Immunocompromised Participants
The purpose of this observational study is to investigate whether a sufficient concentration of itraconazole can influence disappearance of a fever (defeverscence) when intravenous (into the vein) itraconazole is administered for…
- Conditions
- Hematologic Neoplasms, Neutropenia, Fever
- Trial name
- NCT01021683
- Testing
- Itraconazole
- Volunteers
- 203 people
- Sponsor
- Janssen Korea, Ltd., Korea
Febrile Neutropenia, Cancer
Multi-level Evaluation of Chemotherapy-induced Febrile Neutropenia Prophylaxis, Outcomes, and Determinants With Granulocyte-colony Stimulating Factor
This international, prospective, observational, open-label, pharmaco-epidemiologic study observes cancer patients at risk for chemotherapy-induced febrile neutropenia (FN) who are receiving filgrastim biosimilar (EP2006) for…
- Conditions
- Febrile Neutropenia, Cancer, Breast Cancer, Ovarian Cancer
- Trial name
- Monitor-GCSF (NCT01459653)
- Where
- 117 sites in Austria, Belgium and 10 more
- Volunteers
- 1,496 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