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

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

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. The patient signs the informed consent form and voluntarily participate in this study;
  2. Age ≥18 years;
  3. Have the ability to read and understand Chinese;
  4. Pathologically or histologically confirmed diagnosis of non-myeloid malignant tumordiseases (including solid tumors and malignant hematologic tumors);
  5. 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);
  6. 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);
  7. ECOG (Eastern Cooperative Oncology Group score) score 0-1 points;
  8. Expected survival ≥3 months;
  9. Good function of major organs, meeting the following criteria:
  10. Neutrophil count ≥1.5 ×109/L;
  11. Platelet count≥75 ×109/L;
  12. Hemoglobin level≥80 g/L.
  13. 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:

  1. Women who are planning to become pregnant or breastfeeding;
  2. Allergic to polyacrylate adhesives, HHPG-19K, polyethylene glycol recombinant humangranulocyte stimulating factor, recombinant human granulocyte stimulating factor andother preparations expressed in Escherichia coli;
  3. Having a history of bone marrow transplantation and/or stem cell transplantation;
  4. 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
    China

    Site Not Available

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