NCT06254742撤回3 期
Study on 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
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 入组人数
- 107
- 主要终点
- The preference ratio of patients for HHPG-19K and Auto-HHPG-19K , as assessed in the Patient Preference Questionnaire"Considering your overall experience in this study, which administration method do you prefer for drug injection?"
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient signs the informed consent form and voluntarily participate in this study;
- •Age ≥18 years;
- •Have the ability to read and understand Chinese;
- •Pathologically or histologically confirmed diagnosis of non-myeloid malignant tumor diseases (including solid tumors and malignant hematologic tumors);
- •Patients who plan to receive at least two consecutive cycles of anti-tumor trerapy based on a moderate to high FN risk chemotherapy regimen (see Appendix 4 for details of the chemotherapy regimen);
- •The investigator determines that the patient are eligible to receive administration of HHPG-19K injection and Auto-HHPG-19K injection (delivered through an adhesive patch automatic drug delivery device);
- •ECOG (Eastern Cooperative Oncology Group score) score 0-1 points;
- •Expected survival ≥3 months;
- •Good function of major organs, meeting the following criteria:
- •Neutrophil count ≥1.5 ×109/L;
- •Platelet count≥75 ×109/L;
- •Hemoglobin level≥80 g/L.
- •Women of childbearing age must take a blood pregnancy test within 3 days before randomization, and the result is negative, and they should not be lactating. Female subjects of childbearing age and male subjects whose partners are women of childbearing age must agree to approach highly effective contraceptive methods from the day of signing the informed consent form until at least 6 months after the last administration (for female subjects) or 3 months after the last administration (for male subjects).
排除标准
- •Women who are planning to become pregnant or breastfeeding;
- •Allergic to polyacrylate adhesives, HHPG-19K, polyethylene glycol recombinant human granulocyte stimulating factor, recombinant human granulocyte stimulating factor and other preparations expressed in Escherichia coli;
- •Having a history of bone marrow transplantation and/or stem cell transplantation;
- •Other situations deemed unsuitable for inclusion in the study as determined by the investigator
研究组 & 干预措施
Treatment group A
Experimental
first cycle: Auto-HHPG-19K Injection second cycle: HHPG-19K Injection
干预措施: HHPG-19K Injection (Drug)
Treatment group B
Experimental
first cycle: HHPG-19K Injection second cycle: Auto-HHPG-19K Injection
干预措施: HHPG-19K Injection (Drug)
结局指标
主要结局
The preference ratio of patients for HHPG-19K and Auto-HHPG-19K , as assessed in the Patient Preference Questionnaire"Considering your overall experience in this study, which administration method do you prefer for drug injection?"
时间窗: Evaluation after administration on Day 2 of Cycle 2 (each cycle is approximately 21 days)
The available options for a participant's response were HHPG-19K, Auto-HHPG-19K, and No preference.
次要结局
- Incidence of adverse events Auto-HHPG-19K Injection.(From screening period to the last follow-up visit(approximately up to 2 months ))
- Factors influencing patients' preference for HHPG-19K and Auto-HHPG-19K.(Evaluation after administration on Day 2 of Cycle 2 (each cycle is approximately 21 days).)
- The injection experience of patients using HHPG-19K and Auto-HH PG-19K(Evaluation after administration on Day 2 of Cycle 2 (each cycle is approximately 21 days))
- The preference ratio of physicians and nurses for HHPG-19K and Auto-HHPG-19K, according to the question in the "Preference Questionnaire of Physician and Nurse": "Which formulation would you recommend for patient use?"(approximately 2 months)
- Factors influencing the preference of physician and nurse for HHPG-19K and Auto-HHPG-19K(Evaluation after experiencing at least 3 cases of HHPG-19K injection and 3 cases of Auto-HHPG-19K injection therapy)
- The proportion of successful administration of HHPG-19K Injection within 24h-72h after the end of chemotherapy drugs.(Evaluation after administration on Day 2 of Cycle 2 (each cycle is approximately 21 days))
研究者
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