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A prospective, open, single arm study for the efficacy and safty of pegfilgrastim in preventing neutropenia in patients with gynecologic tumors

A prospective, open, single arm study for the efficacy and safty of pegfilgrastim in preventing neutropenia in patients with gynecologic tumors

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900024592
Enrollment
Unknown
Registered
2019-07-18
Start date
2019-08-01
Completion date
Unknown
Last updated
2020-08-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gynecologic Oncology

Interventions

A:short-acting rhG-CSF was given for remedial treatment, 5µg/kg/day until neutrophil count >=2.0x10^9/L
B:no any G-CF was given
C:Give patients PEG-rhG-CSF subcutaneously once in a cycle,6mg for patient's weight = 45kg, 3mg for patient's weight =2.0x10^9/L

Sponsors

TongJi Hospital of TongJi Mediical College,Huazhong University of Science and Technology
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: [1] Age: >= 18 years old, = 70 points; [5] In liver function tests, ALT, AST, and TBIL were all within 2.5 times the upper limit of normal. If it is caused by liver metastasis, the above indicators should be within 5 times of the upper limit of normal; BUN, Cr, and UA of the renal function test should be within 1.5 times of the upper limit of normal; [6] There was no obvious abnormality in the ECG examination; [7] The patient has a good mental consciousness, understands the clinical trial and voluntarily joins the study, and signs the informed consent form; [8] The researchers believe that it can benefit.

Exclusion criteria

Exclusion criteria: [1] Patients who have received pelvic radiotherapy in the recent period (3 months); [2] There are currently uncontrollable infections; [3] Those who have been confirmed to be allergic to PEG-rhG-CSF or rhG-CSF and/or its excipients; [4] Combined with other malignant tumors, except for cured skin basal cell carcinoma or skin squamous cell carcinoma or carcinoma in situ of any other part; [5] Pregnant or lactating women and women planning to become pregnant during clinical observation; [6] Other patients deemed unsuitable by the investigator.

Design outcomes

Primary

MeasureTime frame
the duration of grade IV agranulocytosis;Group C vs Group D: the duration of grade IV agranulocytosis;

Secondary

MeasureTime frame
Group A vs group B: Incidence of febrile neutropenia (FN);Group A vs group B: the recovery time of granulocyte deficiency;Group A vs group B: antibiotic use rate;Group C vs group D: Incidence of febrile neutropenia (FN);Group C vs D group: incidence of grade III/IV granulocytosis;Group C vs group D: antibiotic use rate;

Countries

China

Contacts

Public ContactDing Ma

TongJi Hospital of TongJi Mediical College, Huazhong University of Science and Technology

dingma424@126.com+86 13886090620

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026