Loading clinical trials...

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 | Clinical Trials | Clareo Health

WITHDRAWNPHASE3

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

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

NCT06254742•Jiangsu HengRui Medicine Co., Ltd.

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

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;
+3 more criteria

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

Key Dates

Start Date

February 1, 2024

Primary Completion Date

July 1, 2025

Completion Date

July 1, 2025

Last Updated

August 7, 2025

Conditions

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

Interventions

HHPG-19K Injection

DRUG