Last updated: February 4, 2024
Sponsor: Jiangsu HengRui Medicine Co., Ltd.
Overall Status: Active - Not Recruiting
Phase
3
Condition
Neoplasms
Neutropenia
Treatment
HHPG-19K Injection
Clinical Study ID
NCT06254742
Auto-HHPG-19K-301
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 tumordiseases (including solid tumors and malignant hematologic tumors);
- Patients who plan to receive at least two consecutive cycles of anti-tumor trerapybased on a moderate to high FN risk chemotherapy regimen (see Appendix 4 for detailsof the chemotherapy regimen);
- The investigator determines that the patient are eligible to receive administration ofHHPG-19K injection and Auto-HHPG-19K injection (delivered through an adhesive patchautomatic 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 beforerandomization, and the result is negative, and they should not be lactating. Femalesubjects of childbearing age and male subjects whose partners are women ofchildbearing age must agree to approach highly effective contraceptive methods fromthe day of signing the informed consent form until at least 6 months after the lastadministration (for female subjects) or 3 months after the last administration (formale subjects).
Exclusion
Exclusion Criteria:
- Women who are planning to become pregnant or breastfeeding;
- Allergic to polyacrylate adhesives, HHPG-19K, polyethylene glycol recombinant humangranulocyte stimulating factor, recombinant human granulocyte stimulating factor andother 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 theinvestigator
Study Design
Total Participants: 107
Treatment Group(s): 1
Primary Treatment: HHPG-19K Injection
Phase: 3
Study Start date:
February 01, 2024
Estimated Completion Date:
June 30, 2024
Connect with a study center
Henan Cancer Hospita
Zhengzhou, Henan 450003
ChinaSite Not Available
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