NeutropeniaNCT07434063
Real-world Study on the Prevention of Neutropenia After Tumor Treatment With Mecapegfilgrastim Injection
An observational study of Neutropenia, run by Hebei Medical University Fourth Hospital at 1 site in China.
Trial summary
This study is a multicenter, observational real-world study, aiming to observe and evaluate the efficacy and safety of prophylactic application of Mecapegfilgrastim Injection in tumor patients after radiotherapy/chemotherapy/immunotherapy in the real world to prevent neutropenia.The subjects who met the inclusion… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neutropenia
- What is being tested?
- Mecapegfilgrastim Injection
- Type of treatment
- Injection or infusion
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 18 Jun 2025to 30 Jun 2027
- How long will I take part?
- 42 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: For subjects who need radiotherapy/chemotherapy/immunotherapy after solid malignant tumors, the researchers believe that primary/secondary prevention of thiapegfegostine injection is required after tumor treatment
Who may be able to join
- 1. Patients with malignant tumors confirmed by histopathology or cytology; 2. Age ≥18 years old; 3. After referring to various guidelines, the researchers believed that the subjects:
- Patients who are currently receiving treatment regimens with high FN risk;
- Patients who are currently receiving treatment regimens for moderate FN risk and meet any one of the factors that increase the risk coefficient;
- FN or dose-limiting neutropenia events have occurred in previous treatment cycles;
- In addition to the above, the researchers believe that the medication regimens will cause neutropenia and affect the normal treatment of the subjects; 4. Researchers believe that they can benefit; 5. Voluntarily participate in this clinical trial and be able to sign the informed consent form in person.
Who cannot join
- 1. Those who are allergic to the test drug； 2. Those with mental or neurological disorders who are unable to cooperate； 3. Pregnant or lactating female patients; Women of childbearing age who refuse to take contraceptive measures； 4. Those who were considered unsuitable for inclusion by the researchers.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
HebeiMuFH
Shijiazhuang, Hebei
cheng doctor, 18531117159, jiekejaker@sina.com
About this study
This study is a multicenter, observational real-world study, aiming to observe and evaluate the efficacy and safety of prophylactic application of Mecapegfilgrastim Injection in tumor patients after radiotherapy/chemotherapy/immunotherapy in the real world to prevent neutropenia.The subjects who met the inclusion criteria of the protocol were defined as those who needed radiotherapy/chemotherapy/immunotherapy after being diagnosed with solid malignant tumors. The researchers believed that the subjects needed to use Mecapegfilgrastim Injection for primary/secondary prevention after receiving tumor treatment.
- Conditions
- Neutropenia
- Being tested
- Mecapegfilgrastim Injection
- Medical subject headings
- Neutropenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mecapegfilgrastim InjectionDrug
Use it 24 hours after the end of each treatment cycle at a fixed dose of 6 mg or 100μg/kg each time
| Study group | Role | What they receive |
|---|---|---|
| Subjects who need radiotherapy/chemotherapy/immunotherapy after solid malignant tumors | Not described Receives: Drug: Mecapegfilgrastim Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of FN
The incidence of neutropenic fever (FN) in the first cycle
Measured: From enrollment to the end of treatment 3 weeks later
Secondary outcomes (1)
The incidence of grade 3 and 4 neutropenia
The incidence of grade 3 and 4 neutropenia
Measured: From enrollment to the end of treatment 6 weeks later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2026
- Study start18 Jun 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeutropeniaStudies of the same condition, open and under way.
- More trials run by Hebei Medical University Fourth HospitalThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 42 Days
Sponsor and investigators
- Lead sponsor
- Hebei Medical University Fourth Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jun wang, Hebei Medical University Fourth Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07434063
- Sponsor's protocol ID
- HBAD-FN-ZLZH001
- Status last verified
- Feb 2026
- First submitted
- 5 Aug 2025
- Last updated
- 25 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-world Study on the Prevention of Neutropenia After Tumor Treatment With Mecapegfilgrastim Injection
- ClinicalTrials.gov ID
- NCT07434063
- Acronym / sponsor ID
- HBAD-FN-ZLZH001
- Conditions
- Neutropenia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Hebei Medical University Fourth HospitalUniversity, hospital or other
- Study start
- 18 Jun 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 25 Feb 2026 (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.
This study is a multicenter, observational real-world study, aiming to observe and evaluate the efficacy and safety of prophylactic application of Mecapegfilgrastim Injection in tumor patients after radiotherapy/chemotherapy/immunotherapy in the real world to prevent neutropenia.The subjects who met the inclusion criteria of the protocol were defined as those who needed radiotherapy/chemotherapy/immunotherapy after being diagnosed with solid malignant tumors. The researchers believed that the subjects needed to use Mecapegfilgrastim Injection for primary/secondary prevention after receiving tumor treatment.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 42 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects who need radiotherapy/chemotherapy/immunotherapy after solid malignant tumors | – | Drug: Mecapegfilgrastim Injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- For subjects who need radiotherapy/chemotherapy/immunotherapy after solid malignant tumors, the researchers believe that primary/secondary prevention of thiapegfegostine injection is required after tumor treatment
Key inclusion criteria (5 listed)
- 1. Patients with malignant tumors confirmed by histopathology or cytology; 2. Age ≥18 years old; 3. After referring to various guidelines, the researchers believed that the subjects:
Key exclusion criteria (1 listed)
- 1. Those who are allergic to the test drug； 2. Those with mental or neurological disorders who are unable to cooperate； 3. Pregnant or lactating female patients; Women of childbearing age who refuse to take contraceptive measures； 4. Those who were considered unsuitable for inclusion by the researchers.
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 |
|---|---|---|
| Mecapegfilgrastim InjectionUse it 24 hours after the end of each treatment cycle at a fixed dose of 6 mg or 100μg/kg each time | Drug | Subjects who need radiotherapy/chemotherapy/immunotherapy after solid malignant tumors |
Primary outcome
Incidence of FN
Time frame: From enrollment to the end of treatment 3 weeks later
The incidence of neutropenic fever (FN) in the first cycle
1 secondary outcome
The incidence of grade 3 and 4 neutropenia
Time frame: From enrollment to the end of treatment 6 weeks later
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2026.
- Individual participant dataSharing planned: No
Related trials for Neutropenia
Enrolling by invitationObservational study
Screening for Hematology Branch Protocols
Hematologic Disease and Disorders, Donors
RecruitingObservational study
Pivotal Study to Validate a Novel System to Non-Invasively Detect Severe Neutropenia
Diffuse Large B Cell Lymphoma, Multiple Myeloma
RecruitingPhase 4
Adjustment of Antibiotic Dosage in Pediatric Oncology Patients With Febrile Neutropenia and Augmented Renal Clearance
Febrile Neutropenia
Not yet recruitingPhase 2
A Study to Investigate the Safety and Tolerability of Granulocyte-colony Stimulating Factor (G-CSF) Dosage Reduction in Mavorixafor-treated Participants With Acquired Primary Autoimmune and Idiopathic Chronic Neutropenia Disorders
Acquired Primary Autoimmune and Idiopathic Chronic Neutropenia Disorders, Chronic Neutropenia
Not yet recruiting
Diagnostic Accuracy, Clinical Utility and Implementation of Point-of-Care Absolute Neutrophil Count in Suspected Neutropenic Fever (DUCATIS) - Diagnostic Accuracy (S1)
Suspected Neutropenic Fever, Confirmed Neutropenic Fever
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neutropenia, run by Hebei Medical University Fourth Hospital at 1 site in China.
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 5 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 25 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact cheng doctor (18531117159, jiekejaker@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of FN (time frame: From enrollment to the end of treatment 3 weeks later). 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 25 Feb 2026.