A Trial of HHPG-19K Injection and Auto-HHPG-19K Injection in Prevention of Chemotherapy-related M… (NCT06254742) | Clinical Trial Compass
WithdrawnPhase 3
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
Stopped: The sponsor's R\&D strategy is adjusted.
0Started 2024-02
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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;
Exclusion criteria
✕. 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;
What they're measuring
1
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?"
Timeframe: Evaluation after administration on Day 2 of Cycle 2 (each cycle is approximately 21 days)