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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Patients With Nonmyeloid Malignancies Receiving Antineoplastic Therapy Based on Chemotherapy Regimens at Moderate to High Febrile Neutropenia (FN) Risk
• Intervention / Treatment: Drug: HHPG-19K Injection

• Study Type: Interventional
• Enrollment (Estimated): 107
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Pan Huang; Phone Number: +0518-82342973; Email: pan.huang.ph18@hengrui.com

Study Locations

• China
  • Henan
    • Zhengzhou, Henan, China, 450003
      • Henan Cancer Hospita
      • Principal Investigator: Min Yan
      • Principal Investigator: Zhenzhen Liu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment group A; first cycle: Auto-HHPG-19K Injection second cycle: HHPG-19K Injection	Drug: HHPG-19K Injection; first cycle: Auto-HHPG-19K Injection or HHPG-19K Injection second cycle: HHPG-19K Injection or Auto-HHPG-19K Injection
Experimental: Treatment group B; first cycle: HHPG-19K Injection second cycle: Auto-HHPG-19K Injection	Drug: HHPG-19K Injection; first cycle: Auto-HHPG-19K Injection or HHPG-19K Injection second cycle: HHPG-19K Injection or Auto-HHPG-19K Injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The preference ratio of patients for HHPG-19K and Auto-HHPG-19K , as assessed in the Patient Preference Questionnaire"Considering your overall experience in this study, which administration method do you prefer for drug injection?"	The available options for a participant's response were HHPG-19K, Auto-HHPG-19K, and No preference.	Evaluation after administration on Day 2 of Cycle 2 (each cycle is approximately 21 days)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The preference ratio of physicians and nurses for HHPG-19K and Auto-HHPG-19K, according to the question in the "Preference Questionnaire of Physician and Nurse": "Which formulation would you recommend for patient use?"	The available options for a participant's response were HHPG-19K, Auto-HHPG-19K, and No preference.	approximately 2 months
Factors influencing patients' preference for HHPG-19K and Auto-HHPG-19K.	According to participants' response in the Patient Preference Questionnaire and the Patient Satisfaction Questionnaire, conducting descriptive summaries of influencing factors, including physical condition, convenience, injection pain, and individual evaluation. The available options for a participant's response in the Patient Satisfaction Questionnaire were No, a little, quite, and extremely. The available options for a participant's response in the Patient Preference Questionnaire were HHPG-19K, Auto-HHPG-19K, and No preference.	Evaluation after administration on Day 2 of Cycle 2 (each cycle is approximately 21 days).
Factors influencing the preference of physician and nurse for HHPG-19K and Auto-HHPG-19K	Influencing factors were analysed according to the items in the Preference Questionnaire of Physician and Nurse.	Evaluation after experiencing at least 3 cases of HHPG-19K injection and 3 cases of Auto-HHPG-19K injection therapy
The injection experience of patients using HHPG-19K and Auto-HH PG-19K	Conduct descriptive summaries based on the patient's injection experience items in the Patient Satisfaction Questionnaire. The available options for a participant's response in the Patient Satisfaction Questionnaire were No, a little, quite, and extremely.	Evaluation after administration on Day 2 of Cycle 2 (each cycle is approximately 21 days)
The proportion of successful administration of HHPG-19K Injection within 24h-72h after the end of chemotherapy drugs.	The proportion was summarized based on the time of HHPG-19K administration for each patient.	Evaluation after administration on Day 2 of Cycle 2 (each cycle is approximately 21 days)
Incidence of adverse events Auto-HHPG-19K Injection.	Adverse events were assessed by CTCAE v5.0	From screening period to the last follow-up visit(approximately up to 2 months )

Collaborators and Investigators

• Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2024
• Primary Completion (Estimated): May 1, 2024
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: January 21, 2024
• First Submitted That Met QC Criteria: February 4, 2024
• First Posted (Actual): February 12, 2024

Study Record Updates

• Last Update Posted (Actual): February 12, 2024
• Last Update Submitted That Met QC Criteria: February 4, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hematologic Diseases; Agranulocytosis; Leukopenia; Leukocyte Disorders; Neoplasms; Neutropenia; Febrile Neutropenia
• Other Study ID Numbers: Auto-HHPG-19K-301

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No