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Trial Title:
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
NCT ID:
NCT06254742
Condition:
Patients With Nonmyeloid Malignancies Receiving Antineoplastic Therapy Based on Chemotherapy Regimens at Moderate to High Febrile Neutropenia (FN) Risk
Conditions: Official terms:
Neoplasms
Neutropenia
Febrile Neutropenia
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Crossover Assignment
Primary purpose:
Prevention
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
HHPG-19K Injection
Description:
first cycle: Auto-HHPG-19K Injection or HHPG-19K Injection second cycle: HHPG-19K
Injection or Auto-HHPG-19K Injection
Arm group label:
Treatment group A
Arm group label:
Treatment group B
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Henan Cancer Hospita
Address:
City:
Zhengzhou
Zip:
450003
Country:
China
Investigator:
Last name:
Zhenzhen Liu
Email:
Principal Investigator
Investigator:
Last name:
Min Yan
Email:
Principal Investigator
Start date:
February 2024
Completion date:
June 2024
Lead sponsor:
Agency:
Jiangsu HengRui Medicine Co., Ltd.
Agency class:
Industry
Source:
Jiangsu HengRui Medicine Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06254742
