Trials / Unknown
UnknownNCT03846414
Real World Study of PEG-rhG-CSF in Prevention of Chemotherapy-induced Neutropenia
Real World Study of PEGylated Recombinant Human Granulocyte Stimulating Factor(PEG-rhG-CSF) in Prevention of Chemotherapy-induced Neutropenia
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 1,500 (estimated)
- Sponsor
- CSPC Baike (Shandong) Biopharmaceutical Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | PEG-rhG-CSF | PEG-rhG-CSF was administered 24 hours after the end of chemotherapy for each chemotherapy cycle. |
Timeline
- Start date
- 2019-02-13
- Primary completion
- 2020-04-01
- Completion
- 2020-10-01
- First posted
- 2019-02-19
- Last updated
- 2019-02-19
Source: ClinicalTrials.gov record NCT03846414. Inclusion in this directory is not an endorsement.