Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03846414
Other study ID # CSPC-JYL-RWS-07
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date February 13, 2019
Est. completion date October 1, 2020

Study information

Verified date February 2019
Source CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.
Contact Sun Guoping
Phone 13805609309
Email sunguoping@ahmu.edu.cn
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The aim of this study is to observe and evaluate the cost-effectiveness,efficacy and safety of PEG-rhG-CSF in preventing chemotherapy-induced neutropenia(CIN) of cancer patients in the real world.1000 patients with non-myeloid malignancy who is planned to receive PEG-rhG-CSF for CIN prevention and 500 patients with non-myeloid malignancy who is planned to receive rhG-CSF for CIN prevention or treatment were prospectively recruited.The primary outcome was cost-effectiveness and second outcome was febrile neutropenia,the incidence and duration of grade IV neutropenia,chemotherapy delay,incidence of reduced dose of chemotherapy and relative dose intensity of chemotherapy.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 1500
Est. completion date October 1, 2020
Est. primary completion date April 1, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

1. Patients' age=18 years old, male or female

2. Diagnosis of non-myeloid malignant solid tumors

3. Patients are planned to perform chemotherapy and preventive use the PEG-rhG-CSF or preventive or therapeutic use of rhG-CSF after chemotherapy

4. Patients' mental status are well, could understand the study and willing to participate the study, sign the informed consent form

5. The investigator believes that patients can benefit from this study

Exclusion Criteria:

1. Patients who have been confirmed to be allergic to Jinyouli® or rhG-CSF or its excipients

2. Pregnant or lactating women and women who plan to be pregnant during clinical observation

3. Other patients that the doctor believe not suitable for inclusion

Study Design


Intervention

Drug:
PEG-rhG-CSF
PEG-rhG-CSF was administered 24 hours after the end of chemotherapy for each chemotherapy cycle.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.

Outcome

Type Measure Description Time frame Safety issue
Other Incidence of adverse events All adverse events will be recorded from the time of patients signing the informed consent form up to 30 days after the last Intervention drug is applied. the adverse event that associated with the study drug will be specially recorded. From date of randomization until the date of the study completion,an average of 3 month
Primary Cost-Effectiveness Based on the results of the incidence of febrile neutropenia(FN) and the cost perFN in each group, the incremental cost-effectiveness ratio were estimated using the following formula: (CostA-CostB)/(OutcomeA-OutcomeB) through the chemotherapy cycles of PEG-rhG-CSF or rhG-CSF treatment,an average of 3 month
Secondary The incidence of febrile neutropenia Febrile neutropenia (FN) is defined as oral temperature >38.3 ?(under arm temperature >38.1 ?) or continuous measurement of oral temperature >38?(under arm temperature >37.8?) in 2h, and absolute neutrophil count(ANC) <0.5×10^9/L, or expected to be <0.5×10^9/L From date of randomization until the date of the study completion,an average of 3 month
Secondary The incidence of grade IV neutropenia Grade IV neutropenia is defined as the absolute neutrophil count(ANC)<0.5×10^9/L From date of randomization until the date of the study completion,an average of 3 month
Secondary The duration of grade IV neutropenia in every chemotherapy cycle Defined as days when the ANC<2.0×10^9/L occurs to the time when the ANC=2.0×10^9/L, take the median From date of randomization until the date of the study completion,an average of 3 month
Secondary The incidence of the chemotherapy delay Chemotherapy delay is defined as the delay in starting the next planned chemotherapy for more than 3 days. From date of randomization until the date of the study completion,an average of 3 month
Secondary The duration of the chemotherapy delay in every chemotherapy cycle The duration of the chemotherapy delay in every chemotherapy cycle From date of randomization until the date of the study completion,an average of 3 month
Secondary The incidence of the dose reduction The incidence of the reduction of planned dose of chemotherapy From date of randomization until the date of the study completion,an average of 3 month
Secondary Relative chemotherapy dose intensity in every chemotherapy cycle Relative chemotherapy dose intensity is defined as the actual chemotherapy dose the patient used divided by the planned chemotherapy dose,or the actual chemotherapy time divided by the planned chemotherapy time From date of randomization until the date of the study completion,an average of 3 month
See also
  Status Clinical Trial Phase
Completed NCT02643901 - Tolerability and Pharmacokinetics(PK)/Pharmacodynamics(PD) Study of GW003 in Healthy Subjects Phase 1
Completed NCT02251977 - Effect of GM1 in Prevention of Oxaliplatin Induced Neurotoxicity in Stage II/III Colorectal Cancer Phase 3
Terminated NCT02454530 - Use of Biosimilar Nivestim® to Prevent Chemo-induced Neutropenia. Real Life Study
Active, not recruiting NCT02104830 - Study of the Efficacy and Safety of Empegfilgrastim for Neutropenia Prophylaxis in Cancer Patients Phase 3
Completed NCT04914702 - Feasibility and Comparison of Continuously Monitored Vital Signs in Pediatric Patients With Cancer.
Active, not recruiting NCT03294577 - Plinabulin vs. Pegfilgrastim in Prevention of TAC Induced Neutropenia Phase 3
Not yet recruiting NCT03701841 - Efficacy, Safety and Cost-effectiveness of PEG-rhG-CSF for Primary vs Secondary Prophylaxis
Completed NCT00776165 - Safety and Efficacy Trial of Recombinant Human Granulocyte Colony Stimulating Factor (GCSF) Phase 3
Completed NCT03251768 - Recombinant Human Serum Albumin/Granulocyte Colony Stimulating Factor Fusion Protein for Breast Cancer Patients Phase 2
Recruiting NCT04101760 - Granulocyte Colony Stimulating Factor for for the Prevention of Febrile Neutropenia in Epithelial Ovarian Cancer Phase 3
Completed NCT04134429 - Feasibility of Monitoring Health Data in Pediatric Patients Undergoing Chemotherapy
Completed NCT04227990 - Plinabulin iv Solution in Prevention of TAC Induced Neutropenia Phase 2
Completed NCT03102606 - Plinabulin vs. Pegfilgrastim in Patients With Solid Tumors Receiving Docetaxel Myelosuppressive Chemotherapy Phase 3 Phase 3
Completed NCT01569087 - Dose-finding Study of Empegfilgrastim for Neutropenia Prophylaxis in Cancer Patients Phase 2
Completed NCT05512676 - Trabectedin/Caelyx vs Cisplatin Hypersensitivity in Relapsed Ovarian Cancer Patients Allergic to Platinum
Completed NCT04460079 - Safety and Effectiveness Assessment of PeGagen® (Pegfilgrastim) in the Prevention of Chemotherapy-induced FN
Recruiting NCT02725606 - Study to Assess the Safety, Tolerability, and Pharmacokinetics/Pharmacodynamics of GW003 in Patients With Breast Cancer Phase 1
Completed NCT02692742 - Efficacy and Safety Phase IIa Study of Myelo001 in Chemotherapy-Induced Neutropenia Phase 2
Completed NCT02532712 - Study to Evaluate the Safety, Tolerability and PK of EC-18 After Oral Administration in Healthy Volunteers Phase 1
Completed NCT01516736 - Phase III Study Comparing the Efficacy and Safety of LA-EP2006 and Peg-Filgrastim Phase 3