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

Hengrui Medicine

Status and phase: Withdrawn; Phase 3

Conditions: Patients With Nonmyeloid Malignancies Receiving Antineoplastic Therapy Based on Chemotherapy Regimens at Moderate to High Febrile Neutropenia (FN) Risk

Treatments: Drug: HHPG-19K Injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT06254742

Auto-HHPG-19K-301

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 tumor diseases (including solid tumors and malignant hematologic tumors);

5. 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);

6. 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);

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:

   1. Neutrophil count ≥1.5 ×109/L;
   2. Platelet count≥75 ×109/L;
   3. Hemoglobin level≥80 g/L.

10. 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).

Exclusion criteria

1. Women who are planning to become pregnant or breastfeeding;
2. 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;
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 the investigator

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Treatment group A

Experimental group

Description:

first cycle: Auto-HHPG-19K Injection second cycle: HHPG-19K Injection

Treatment:

Drug: HHPG-19K Injection

Treatment group B

Experimental group

Description:

first cycle: HHPG-19K Injection second cycle: Auto-HHPG-19K Injection

Treatment:

Drug: HHPG-19K Injection