Patients With Nonmyeloid Malignancies Receiving Antineoplastic Therapy Based on Chemotherapy Regimens at Moderate to High Febrile Neutropenia (FN) RiskPhase 3NCT06254742
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
A Phase 3 study testing HHPG-19K Injection in people with Patients With Nonmyeloid Malignancies Receiving Antineoplastic Therapy Based on Chemotherapy Regimens at Moderate to High Febrile Neutropenia (FN) Risk, run by Jiangsu HengRui Medicine Co., Ltd..
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patients With Nonmyeloid Malignancies Receiving Antineoplastic Therapy Based on Chemotherapy Regimens at Moderate to High Febrile Neutropenia (FN) Risk
- What is being tested?
- HHPG-19K Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Feb 2024to 1 Jul 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient signs the informed consent form and voluntarily participate in this study;
- Age ≥18 years;
- Have the ability to read and understand Chinese;
- Pathologically or histologically confirmed diagnosis of non-myeloid malignant tumor diseases (including solid tumors and malignant hematologic tumors);
- 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);
- 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);
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- ECOG (Eastern Cooperative Oncology Group score) score 0-1 points;
- Expected survival ≥3 months;
- Good function of major organs, meeting the following criteria:
- Neutrophil count ≥1.5 ×109/L;
- Platelet count≥75 ×109/L;
- Hemoglobin level≥80 g/L.
- 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).
Who cannot join
- Women who are planning to become pregnant or breastfeeding;
- 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;
- Having a history of bone marrow transplantation and/or stem cell transplantation;
- Other situations deemed unsuitable for inclusion in the study as determined by the investigator
About this study
Official title: 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.
- Being tested
- HHPG-19K Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HHPG-19K InjectionDrug
first cycle: Auto-HHPG-19K Injection or HHPG-19K Injection second cycle: HHPG-19K Injection or Auto-HHPG-19K Injection
| Study group | Role | What they receive |
|---|---|---|
| Treatment group A | Experimental | first cycle: Auto-HHPG-19K Injection second cycle: HHPG-19K Injection Receives: Drug: HHPG-19K Injection |
| Treatment group B | Experimental | first cycle: HHPG-19K Injection second cycle: Auto-HHPG-19K Injection Receives: Drug: HHPG-19K Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Evaluation after administration on Day 2 of Cycle 2 (each cycle is approximately 21 days)
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: From screening period to the last follow-up visit(approximately up to 2 months )
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2024
- Study startFeb 2024 (estimated)
- Primary completion1 Jul 2025
- Study completion1 Jul 2025
Why it stopped: The sponsor's R\&D strategy is adjusted.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients With Nonmyeloid Malignancies Receiving Antineoplastic Therapy Based on Chemotherapy Regimens at Moderate to High Febrile Neutropenia (FN) RiskStudies of the same condition, open and under way.
- More trials run by Jiangsu HengRui Medicine Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06254742
- Sponsor's protocol ID
- Auto-HHPG-19K-301
- Status last verified
- Aug 2025
- First submitted
- 21 Jan 2024
- Last updated
- 7 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06254742
- Acronym / sponsor ID
- Auto-HHPG-19K-301
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The sponsor's R\&D strategy is adjusted.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Feb 2024 (estimated)
- Primary completion
- 1 Jul 2025 (actual)
- Study completion
- 1 Jul 2025 (actual)
- First posted
- 12 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group A | Experimental | Drug: HHPG-19K Injectionfirst cycle: Auto-HHPG-19K Injection second cycle: HHPG-19K Injection |
| Treatment group B | Experimental | Drug: HHPG-19K Injectionfirst cycle: HHPG-19K Injection second cycle: Auto-HHPG-19K Injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- The patient signs the informed consent form and voluntarily participate in this study;
- Age ≥18 years;
- Have the ability to read and understand Chinese;
- Pathologically or histologically confirmed diagnosis of non-myeloid malignant tumor diseases (including solid tumors and malignant hematologic tumors);
- 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);
Key exclusion criteria (4 listed)
- Women who are planning to become pregnant or breastfeeding;
- 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;
- Having a history of bone marrow transplantation and/or stem cell transplantation;
- Other situations deemed unsuitable for inclusion in the study as determined by the investigator
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HHPG-19K Injectionfirst cycle: Auto-HHPG-19K Injection or HHPG-19K Injection second cycle: HHPG-19K Injection or Auto-HHPG-19K Injection | Drug | Treatment group A, Treatment group B |
Primary outcome
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?"
Time frame: Evaluation after administration on Day 2 of Cycle 2 (each cycle is approximately 21 days)
The available options for a participant's response were HHPG-19K, Auto-HHPG-19K, and No preference.
6 secondary outcomes
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?"
Time frame: approximately 2 months
Factors influencing patients' preference for HHPG-19K and Auto-HHPG-19K.
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: Evaluation after administration on Day 2 of Cycle 2 (each cycle is approximately 21 days)
Incidence of adverse events Auto-HHPG-19K Injection.
Time frame: From screening period to the last follow-up visit(approximately up to 2 months )
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2025.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing HHPG-19K Injection in people with Patients With Nonmyeloid Malignancies Receiving Antineoplastic Therapy Based on Chemotherapy Regimens at Moderate to High Febrile Neutropenia (FN) Risk, run by Jiangsu HengRui Medicine Co., Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 7 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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?" (time frame: Evaluation after administration on Day 2 of Cycle 2 (each cycle is approximately 21 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2025.