Clinical trials: Neutropenia, Febrile
Pediatric Malignant Solid Tumor, Febrile Neutropenia (FN)
Phase II Study of QLC2519 in Pediatric Solid Tumor Participants
QLC2519 (Mai Li Sheng®) is a new protein drug created by fusing the N-terminal of highly active modified G-CSF with the C-terminal of HSA.
- Conditions
- Pediatric Malignant Solid Tumor, Febrile Neutropenia (FN), Neutropenia
- Trial name
- NCT07724756
- Testing
- Albipagrastim alf
- Where
- China
- Volunteers
- 18 people
- Sponsor
- Qilu Pharmaceutical Co., Ltd.
Invasive Fungal Infections, Neutropenic Fever
Human Bioequivalence Study of Liposomal Amphotericin B for Injection
A single-center, randomized, open-label, single-dose, two-period, double-crossover study to evaluate the bioequivalence of liposomal amphotericin B for injection (test product) manufactured by Sichuan Huiyu Pharmaceutical Co.…
- Conditions
- Invasive Fungal Infections, Neutropenic Fever, Visceral Leishmaniasis
- Trial name
- NCT06983665
- Testing
- Test product (Liposomal amphotericin B for injection, Sichuan Huiyu Pharmaceutical Co., Ltd.), Reference product (AmBisome®, Astellas Pharma US Inc.)
- Where
- China
- Volunteers
- 58 people, healthy volunteers welcome
- Sponsor
- Sichuan Huiyu Pharmaceutical Co., Ltd
Invasive Fungal Infections, Neutropenic Fever
Human Bioequivalence Study of Amphotericin B Liposome for Injection
Single-center, randomized, open-label, single-dose, two-treatment, two-period, two-sequence crossover design to evaluate the human bioequivalence of two Amphotericin B Liposome for Injection formulations
- Conditions
- Invasive Fungal Infections, Neutropenic Fever, Visceral Leishmaniasis
- Trial name
- NCT06977490
- Testing
- Amphotericin B Liposome for Injection (strength: 50 mg, Sichuan Huiyu Pharmaceutical Co., Ltd.), Amphotericin B Liposome for Injection (trade name: Ambisome®, strength: 50 mg, MAH: Gilead Sciences)
- Where
- China
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Sichuan Huiyu Pharmaceutical Co., Ltd
Febrile Neutropenia
A Comparative Evaluation of Pharmacokinetics and Immunogenicity.
The Goal of these study is to evaluate and To compare the pharmacokinetics (PK) of the Test product (T) getting administered through prefilled syringe with on-body injector with Reference product as prefilled syringe following a…
- Trial name
- NCT06918587
- Testing
- TPI-120 with On body injector, Fylntera
- Where
- Jordan
- Volunteers
- 180 people, healthy volunteers welcome
- Sponsor
- Kashiv BioSciences, LLC
Neutropenia, Chemotherapy-Induced Febrile, Breast Neoplasm Female
Study Evaluating PEG-G-CSF Injectionin Preventing Neutropenia After Chemotherapy
To evaluate the efficacy, safety, and immunogenicity of PEG-G-CSF Injection (Kexing Biopharmaceutical Co., Ltd.) for the prevention of neutropenia after chemotherapy, using the PEG-G-CSF Injection ( Neulasta®, Amgen Europe B.V.)…
- Trial name
- NCT06711523
- Testing
- PEG-G-CSF injection (Kexing Biopharmaceutical Co., Ltd.), PEG-G-CSF injection (Neulasta®，Amgen Europe B.V.)
- Where
- China
- Volunteers
- 250 people
- Sponsor
- Kexing Biopharm Co., Ltd.
Patients With Nonmyeloid Malignancies Receiving Antineoplastic Therapy Based on Chemotherapy Regimens at Moderate to High Febrile Neutropenia (FN) Risk
A Trial of HHPG-19K Injection and Auto-HHPG-19K Injection in Prevention of Chemotherapy-related Moderate to Severe Neutropenia of Patients With Nonmyeloid Malignancies
The study is being conducted to evaluate the preference, and safety of HHPG-19K Injection and Auto-HHPG-19K Injection in Prevention of chemotherapy-related moderate to severe neutropenia of Patients with nonmyeloid malignancies.
- Trial name
- NCT06254742
- Testing
- HHPG-19K Injection
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Chemotherapy-Induced Febrile Neutropenia
Compare the Efficacy and Safety of QL0605 Injections at Different Timepoints
The goal of this real-world study is to compare the efficacy and safety of QL0605 administered 24 hours and 48 hours after chemotherapy in breast cancer patients.
- Trial name
- NCT06616571
- Testing
- QL0605(PEG-rhG-CSF)
- Where
- China
- Volunteers
- 336 people
- Sponsor
- Qilu Pharmaceutical Co., Ltd.
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
Breast Cancer Female, Breast Neoplasm Female
An Observational Study to Evaluate the Safety and Efficacy of Pegfilgrastim (Neulasta®)
The purpose of this observational study is to evaluate real-world safety and efficacy of pegfilgrastim (Neulasta) administered as secondary prophylaxis in Korean female patients with breast cancer receiving chemotherapy regimens…
- Trial name
- NCT03433560
- Where
- 3 sites in South Korea
- Volunteers
- 1,300 people
- Sponsor
- Kyowa Kirin Korea Co., Ltd.
Febrile Neutropenia
Management of Severe Chemotherapy-induced Neutropenia in Advanced Breast Cancer
To assess the safety and establish the dose to assess the pharmacokinetic activity following administration of EC-18 in patients with advanced breast cancer receiving low febrile neutropenia risk chemotherapy who are the…
- Trial name
- NCT03104595
- Testing
- EC-18
- Where
- 3 sites in South Korea
- Volunteers
- 28 people
- Sponsor
- Enzychem Lifesciences Corporation
Neutropenia, Febrile, Hematologic Cancer
CEFtolozane-Tazobactam for the Empiric Anti-bacterial Treatment of Neutropenic Fever in Hematology Patients
Patients with blood cancers and those who received a bone marrow transplant frequently have low circulating white blood cell countS.
- Trial name
- CEF-10 (NCT05061654)
- Testing
- Ceftolozane-tazobactam IV
- Where
- Qatar
- Sponsor
- Hamad Medical Corporation
Neutropenia, Neutropenia, Febrile
Investigation of the Usability of Neutrocheck Amongst Healthy Volunteers and Healthcare Professionals.
This study proposes to assess the usability of the Neutrocheck device and test kit amongst healthy volunteers and healthcare professionals (HCPs).
- Conditions
- Neutropenia, Neutropenia, Febrile, Neutropenic Sepsis (Disorder)
- Trial name
- NeutroUSE (NCT05852249)
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- 52 North Health Ltd
Febrile Neutropenia
Remote Temperature Monitoring of Adult Subjects Undergoing Outpatient Stem Cell Transplant or CAR-T Cell Therapy
IDION is currently seeking FDA approval for this device- the IDION iTempShield. It is a skin-safe, FDA complaint and non-invasive device that can read and monitor skin temperature.
- Trial name
- NCT05576220
- Testing
- IDION iTempShield
- Where
- United States
- Volunteers
- 210 people
- Sponsor
- IDION Inc.
Invasive Fungal Infections, Neutropenic Fever
Pharmacokinetics and Safety of AmBisome and DKF-5122
The purpose of the study is to assess the Safety and Pharmacokinetic Characteristics of AmBisome and DKF-5122
- Trial name
- NCT05749380
- Testing
- AmBisome, DKF-5122
- Where
- South Korea
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- Dongkook Pharmaceutical Co., Ltd.
Breast Neoplasms, Chemotherapy-Induced Febrile Neutropenia
Efficacy and Safety Study With MYL-1401H and Neulasta
This is a Multicenter, Double-Blind, Randomized, Comparative Efficacy and Safety Study of MYL-1401H and Neulasta (Pegfilgrastim) in Stage II/III Breast Cancer Patients Receiving Neoadjuvant or Adjuvant Chemotherapy.
- Trial name
- NCT02467868
- Testing
- MYL-1401H, Neulasta
- Where
- 36 sites in Bulgaria, Georgia and 4 more
- Volunteers
- 193 people
- Sponsor
- Mylan Inc.
Non-Myeloid Malignancy
Phase 3 Study to Evaluate the Safety and Efficacy of YPEG-rhG-CSF in Malignancies Receiving Chemotherapy
This phase 3 study is aimed to evaluate the safety and efficacy of YPEG-rhG-CSF in reducing the infection manifested by febrile neutropenia in patients with non-myeloid malignancy who receiving Myelosuppressive Chemotherapy which…
- Trial name
- NCT04466137
- Testing
- YPEG-rhG-CSF, rhG-CSF/PEG-rhG-CSF
- Where
- China
- Volunteers
- 398 people
- Sponsor
- Xiamen Amoytop Biotech Co., Ltd.
Aspergillus Infection, Febrile Neutropenia
Ampholipad Real-World Data in Taiwan
A retrospective, post-marketing, multi-center chart review study includes patients who had been prescribed Ampholipad.
- Conditions
- Aspergillus Infection, Febrile Neutropenia, Candida Infection, Fungal Infection
- Trial name
- NCT03641131
- Where
- 6 sites in Taiwan
- Volunteers
- 102 people
- Sponsor
- Taiwan Liposome Company
Febrile Neutropenia, Non-myeloid Malignancy
An Analysis to Estimate Febrile Neutropenia (FN) in Patients Receiving Udenyca
This is a multicenter, prospective, observational cohort registry in subjects receiving myelosuppressive chemotherapy for a non-myeloid malignancy who are considered to be at high risk for developing febrile neutropenia (FN).
- Trial name
- POEM (NCT04662892)
- Testing
- Pegfilgrastim-Cbqv
- Where
- 3 sites in United States
- Volunteers
- 200 people
- Sponsor
- Coherus Oncology, Inc.
Chemotherapy-induced Neutropenia
Safety and Effectiveness Assessment of PeGagen® (Pegfilgrastim) in the Prevention of Chemotherapy-induced FN
The present study was an observational, multicenter, non-interventional, single arm, open label, PMS study conducted in Iran. The primary objective of this study was safety assessment, including the rate of AEs.
- Trial name
- NCT04460079
- Testing
- Peg-filgrastim
- Volunteers
- 654 people
- Sponsor
- Cinnagen
Febrile Neutropenia, Acute Leukemia
iDTECT Blood Performance for the Identification of Viral or Bacterial Pathogens in Febrile Neutropenic Patients
Prospective, multicentre French observational study assessing the performance and medico-economic utility of iDTECT Blood versus conventional microbiologic diagnosis in patients with febrile neutropenia
- Conditions
- Febrile Neutropenia, Acute Leukemia, Stem Cell Transplantation, Infection
- Trial name
- IDENTIFY (NCT03364257)
- Testing
- iDTECT Blood
- Where
- 5 sites in France
- Volunteers
- 97 people
- Sponsor
- Pathoquest