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New drug aims to fix Chemo-Induced low platelets

NCT ID NCT07185893

Disease control Sponsor: Jun wang Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study tests a drug called Romiplostim N01 in 106 cancer patients whose platelets drop due to chemo, radiation, or immunotherapy. The goal is to see if it can safely raise platelet counts better than the current standard treatment. Patients will be randomly assigned to receive either Romiplostim N01 or another drug (Interleukin-11) for up to 14 days.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Romiplostim N01
What this could lead to
If it works, this could offer a new option to manage low platelets in cancer patients, reducing the need for platelet transfusions and treatment delays.
What could go wrong
This is an early-stage trial with only 106 participants, so results may not apply to all patients. The drug may not work better than existing treatments and could have side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 106 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2025

An estimate. Start dates often move.

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Age:18 to 80 years old (man or female); 2. Confirmed with solid tumor by pathological histology or cytology examination; 3. The patient is undergoing concurrent/sequential radiotherapy ± immunotherapy; 4. During the treatment period, the patient experienced a decrease in platelets, and the platelet count within the last 3 days before enrollment was 25×10\^9/L \< platelet count ≤ 75×10\^9/L; 5. The estimated survival period at screening is ≥ 3 months, and it is expected that the current chemotherapy cycle can be used for ≥ 2 cycles; 6. ECOG 0 - 2; 7. Fully understand and comply with the requirements of this study, and voluntarily sign the informed consent form. Exclusion Criteria: 1. Platelet count ≤ 25×10\^9/L at baseline; 2. The patient has previously received treatments for thrombocytopenia, such as thrombopoietin receptor agonists (TOP-RA), recombinant human thrombopoietin (rhTPO), or rhIL-11, etc.; 3. Patients with hematological disorders, including lymphoma, leukemia, aplastic anemia, primary immune thrombocytopenia, myelodysplastic syndromes, multiple myeloma, and myelodysplastic syndrome, etc.; 4. Have experienced thrombocytopenia due to non-tumor treatment within the past 6 months, including but not limited to EDTA-dependent pseudo-thrombocytopenia, splenomegaly, infection, bleeding, etc.; 5. After red blood cell or erythropoietin (EPO) infusion, hemoglobin is still \< 50g/L, or after granulocyte colony-stimulating factor (G-CSF) treatment, absolute neutrophil count is still \< 1.0×10\^9/L; 6. Have experienced any arterial or venous thrombosis within the past 6 months; 7. Have suffered from severe cardiovascular diseases (such as NYHA cardiac function class III-IV), increased risk of thrombosis-related arrhythmias (such as atrial fibrillation), coronary artery stent implantation, angioplasty, and coronary artery bypass grafting within the past 6 months; 8. Have received platelet transfusion within 5 days before randomization or enrollment; 9. Patients with positive hepatitis C antibody and excessive HCV-RNA detection, positive hepatitis B surface antigen and excessive HBV-DNA detection, patients with severe cirrhosis, positive HIV antibody, or positive syphilis antibody; 10. During screening, for subjects without liver metastasis, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) are ≥ 3 times ULN; for subjects with liver metastasis, ≥ 5 times ULN; 11. Serum creatinine concentration ≥ 1.5 times ULN or eGFR ≤ 60ml/min; 12. Patients who are allergic or intolerant to the active ingredient or excipients of Romiplostim N01 for injection; 13. Planning to get pregnant or in the lactation period; 14. The investigator determines that the patient is not suitable to participate in this trial.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • The Fourth Hospital of Hebei Medical University

    Shijiazhuang, Hebei, China

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