Chemotherapy-induced ThrombocytopeniaPhase 2NCT07063225
Romiplostim N01 for Chemotherapy-induced Thrombocytopenia
A Phase 2 study testing Romiplostim N01 in people with Chemotherapy-induced Thrombocytopenia and Romiplostim N01, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.
Trial summary
To evaluate the efficacy and safety of Romiplostim N01 to treat chemotherapy-induced thrombocytopenia in tumors Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chemotherapy-induced Thrombocytopenia, Romiplostim N01
- What is being tested?
- Romiplostim N01
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- Aug 2025to Aug 2026
- Phase
- Phase 2
- 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
Who may be able to join
- Age: 18 years or above, gender not restricted;
- Patients who meet the diagnostic criteria for chemotherapy-related thrombocytopenia, and still ineffective after repeated treatment with rhTPO or IL-11 (subjects need to undergo regular rhTPO treatment for at least 14 days after radiotherapy and chemotherapy, with a dose of rhTPO 300u/kg/d or higher, and the platelet count remains less than 30×10^9/L, defined as refractory CTIT);
- Patients who have stopped chemotherapy and radiotherapy for more than 1 month;
- Patients with platelet count at enrollment < 30×10^9/L;
- Patients with platelet count remains < 30×10^9/L for more than 1 month;
- Patients with expected survival period ≥ 6 months;
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- Patients with liver and kidney function < 1.5× upper limit of normal value, physical examination qualified;
- Patients with ECOG physical status score ≤ 2 points;
- Patients with Cardiac function: New York Heart Association cardiac function classification is grade 2 or below;
- Patients who is voluntary to sign the informed consent form;
Who cannot join
- Those with uncontrollable primary diseases of important organs, such as extensive metastasis of malignant tumors, liver failure, heart failure, kidney failure and other diseases；
- Patients with poor compliance;
- Positive serology for HIV, hepatitis B virus (HBV), hepatitis C virus (HCV), and/or hepatitis D virus (HDV), Syphilis; Positive for Epstein-Barr Virus DNA, Cytomegalovirus DNA;
- Accompanied by extensive and severe bleeding, such as hemoptysis, upper gastrointestinal bleeding, intracranial hemorrhage, etc.
- There is currently a heart disease requiring treatment or a poorly controlled hypertension judged by the investigator；
- Patients with thrombotic diseases such as pulmonary embolism, thrombosis, and atherosclerosis；
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- Those who have received allogeneic stem cell transplantation or organ transplantation in the past；
- Patients with mental disorders who cannot normally obtain informed consent and undergo trials and follow-up；
- Patients whose toxic symptoms caused by treatment before participating in the trial have not disappeared；
- Other serious diseases that may restrict participants from participating in this trial (such as diabetes; severe heart failure; myocardial obstruction or unstable arrhythmia or unstable angina in the past 6 months; gastric ulcers; mobility Autoimmune diseases, etc.)；
- Patients with sepsis or patients with other irregular bleeding；
- Patients taking antiplatelet drugs at the same time；
- Pregnant women, suspected pregnancy (a positive pregnancy test for human chorionic gonadotropin in urine at screening) and breastfeeding patients； Pre-existing cardiac disease, including congestive heart failure of New York Heart Association [NYHA] Grade III/IV, arrhythmia requiring treatment or myocardial infarction within the last 6 months. No arrhythmia known to increase the risk of thrombotic events (e.g. atrial fibrillation), or patients with a QT >450msec or QTc > 480 for patients with a Bundle Branch Block;
- Researchers believe that patients should not participate in the test of any other condition.
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
Chinese Academy of Medical Science and Blood Disease Hospital
Tianjin, Tianjin Municipality, 301600
Ting Sun, MD, 8623608180, sunting@ihcams.ac.cn
Lei Zhang, MD, 8623608185, zhanglei1@ihcams.ac.cn
About this study
Official title: Romiplostim N01 for Chemotherapy-induced Thrombocytopenia in Tumors: a Prospective Multi-center One-arm Study
To evaluate the efficacy and safety of Romiplostim N01 to treat chemotherapy-induced thrombocytopenia in tumors
Read the detailed description
The investigator had registered a clinical trial of Eltrombopag in the treatment of chemotherapy-induced thrombocytopenia（NCT04600960）. Due to the late launch of Romiplostim N01 in China, the investigator also collected the information of Romiplostim N01 in the treatment of chemotherapy-induced thrombocytopenia according to the protocal of Eltrombopag in the treatment of chemotherapy-induced thrombocytopenia（NCT04600960）.
This is a single-arm study to evaluate the safety and efficacy of Romiplostim N01 to treat chemotherapy-induced thrombocytopenia （CIT）in tumors. These subjects have been treated with recombinant human thrombopoietin（rhTPO） or interleukin 11（IL-11） before, the platelets can rise to normal or reach the effective standard, but after the re-application, the effective standard is not reached, or the effective standard is still not reached after the rhTPO 300U/kg/d treatment for 14 days. The investigator will assess the changes of the platelet counts after the treatment of Romiplostim N01 from week 1 to week 24, and observe incidence of adverse events during the treatment of Romiplostim N01. The investigator will complete the 4 weeks safety visits（once a week），if the subjects end or withdraw from the clinical trial.
Patients with chemotherapy-induced thrombocytopenia who had the same inclusion and exclusion criteria in the same period or in the past will be compared with the efficacy and safety of supportive treatment and Eltrombopag in the same period or history, so as to preliminarily explore and evaluate the efficacy and safety of Romiplostim N01 treatment.
- Being tested
- Romiplostim N01
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Romiplostim N01Drug
The subjects will receive ropivacaine N01 treatment, with an initial dose of (2-3) µg/kg. When the dose is less than 250 µg, 250 µg (1 vial) can be administered (subcutaneously), once a week. The dose will be increased by (1) µg/kg each week, up to a maximum of 10 µg/kg, until the platelet count reaches ≥ 50 × 10^9/L. If the platelet count returns to normal, the dose can be reduced according to the platelet level as appropriate.
| Study group | Role | What they receive |
|---|---|---|
| Romiplostim N01 | Experimental | 50 enrolled subjects will be picked up to take Romiplostim N01 at the indicated dose. Receives: Drug: Romiplostim N01 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficiency after 12 weeks of treatment with Romiplostim N01
The proportion of patients whose platelet count was ≥ 50 × 10^9/L after 12 weeks (3 months) of treatment with Romiplostim N01.
Measured: 12 weeks
Secondary outcomes (5)
Other efficacy evaluation after 12 weeks of treatment with Romiplostim N01
The proportion of patients whose platelet count was ≥ 30×10^9/L or ≥ 100×10^9/L after 12 weeks (3 months) of treatment with Romiplostim N01
Measured: 12 weeks
Efficiency after 24 weeks of treatment with Romiplostim N01
The proportion of patients whose platelet count was ≥ 30×10^9/L, ≥ 50×10^9/L, or ≥ 100×10^9/L after 24 weeks (6 months) of treatment with Romiplostim N01
Measured: 24 weeks
Platelet counts at each visit point
Platelet counts after the treatment of Romiplostim N01 at each visit point
Measured: 24 weeks
WHO bleeding scale at each visit point
Changes of the WHO bleeding scale after the treatment of Romiplostim N01 at each visit point. The WHO Bleeding Scale is a measure of bleeding severity with the following grades: grade 0 = no bleeding, grade 1= petechiae, grade 2= mild blood loss, grade 3 = gross blood loss, and grade 4 = debilitating blood loss.
Measured: 24 weeks
Adverse events
Incidence, severity, and relationship of treatment emergent adverse events after Romiplostim N01 treatment
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2025
- Study startAug 2025 (estimated)
- Primary completionAug 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chemotherapy-induced ThrombocytopeniaStudies of the same condition, open and under way.
- More trials run by Institute of Hematology & Blood Diseases Hospital, ChinaThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Tianjin Medical University Cancer Institute and Hospital, Tianjin Medical University Second Hospital, Tianjin Third Central Hospital, Tianjin People's Hospital, Henan Cancer Hospital, The Second Affiliated Hospital of Kunming Medical University
- Responsible party
- Sponsor
- Investigators
- Yunfei Chen, MD, Principal investigator, Chinese Academy of Medical Science and Blood Disease Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07063225
- Sponsor's protocol ID
- IIT2025061
- Status last verified
- Jun 2025
- First submitted
- 3 Jul 2025
- Last updated
- 14 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Researchers qualified can request the dataset, including de-identified individual subject data. Data may be requested from PI from 12 months to 36 months after study completion.
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Romiplostim N01 for Chemotherapy-induced Thrombocytopenia in Tumors: a Prospective Multi-center One-arm Study
- ClinicalTrials.gov ID
- NCT07063225
- Acronym / sponsor ID
- IIT2025061
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, ChinaUniversity, hospital or other
- Collaborators
- Tianjin Medical University Cancer Institute and Hospital, Tianjin Medical University Second Hospital, Tianjin Third Central Hospital, Tianjin People's Hospital, Henan Cancer Hospital, The Second Affiliated Hospital of Kunming Medical University
- Study start
- Aug 2025 (estimated)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 14 Jul 2025 (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.
To evaluate the efficacy and safety of Romiplostim N01 to treat chemotherapy-induced thrombocytopenia in tumors
Detailed description
The investigator had registered a clinical trial of Eltrombopag in the treatment of chemotherapy-induced thrombocytopenia（NCT04600960）. Due to the late launch of Romiplostim N01 in China, the investigator also collected the information of Romiplostim N01 in the treatment of chemotherapy-induced thrombocytopenia according to the protocal of Eltrombopag in the treatment of chemotherapy-induced thrombocytopenia（NCT04600960）.
This is a single-arm study to evaluate the safety and efficacy of Romiplostim N01 to treat chemotherapy-induced thrombocytopenia （CIT）in tumors. These subjects have been treated with recombinant human thrombopoietin（rhTPO） or interleukin 11（IL-11） before, the platelets can rise to normal or reach the effective standard, but after the re-application, the effective standard is not reached, or the effective standard is still not reached after the rhTPO 300U/kg/d treatment for 14 days. The investigator will assess the changes of the platelet counts after the treatment of Romiplostim N01 from week 1 to week 24, and observe incidence of adverse events during the treatment of Romiplostim N01. The investigator will complete the 4 weeks safety visits（once a week），if the subjects end or withdraw from the clinical trial.
Patients with chemotherapy-induced thrombocytopenia who had the same inclusion and exclusion criteria in the same period or in the past will be compared with the efficacy and safety of supportive treatment and Eltrombopag in the same period or history, so as to preliminarily explore and evaluate the efficacy and safety of Romiplostim N01 treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Romiplostim N01 | Experimental | Drug: Romiplostim N0150 enrolled subjects will be picked up to take Romiplostim N01 at the indicated dose. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age: 18 years or above, gender not restricted;
- Patients who meet the diagnostic criteria for chemotherapy-related thrombocytopenia, and still ineffective after repeated treatment with rhTPO or IL-11 (subjects need to undergo regular rhTPO treatment for at least 14 days after radiotherapy and chemotherapy, with a dose of rhTPO 300u/kg/d or higher, and the platelet count remains less than 30×10^9/L, defined as refractory CTIT);
- Patients who have stopped chemotherapy and radiotherapy for more than 1 month;
- Patients with platelet count at enrollment < 30×10^9/L;
- Patients with platelet count remains < 30×10^9/L for more than 1 month;
Key exclusion criteria (14 listed)
- Those with uncontrollable primary diseases of important organs, such as extensive metastasis of malignant tumors, liver failure, heart failure, kidney failure and other diseases；
- Patients with poor compliance;
- Positive serology for HIV, hepatitis B virus (HBV), hepatitis C virus (HCV), and/or hepatitis D virus (HDV), Syphilis; Positive for Epstein-Barr Virus DNA, Cytomegalovirus DNA;
- Accompanied by extensive and severe bleeding, such as hemoptysis, upper gastrointestinal bleeding, intracranial hemorrhage, etc.
- There is currently a heart disease requiring treatment or a poorly controlled hypertension judged 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 |
|---|---|---|
| Romiplostim N01The subjects will receive ropivacaine N01 treatment, with an initial dose of (2-3) µg/kg. When the dose is less than 250 µg, 250 µg (1 vial) can be administered (subcutaneously), once a week. The dose will be increased by (1) µg/kg each week, up to a maximum of 10 µg/kg, until the platelet count reaches ≥ 50 × 10^9/L. If the platelet count returns to normal, the dose can be reduced according to the platelet level as appropriate. | Drug | Romiplostim N01 |
Primary outcome
Efficiency after 12 weeks of treatment with Romiplostim N01
Time frame: 12 weeks
The proportion of patients whose platelet count was ≥ 50 × 10^9/L after 12 weeks (3 months) of treatment with Romiplostim N01.
5 secondary outcomes
Other efficacy evaluation after 12 weeks of treatment with Romiplostim N01
Time frame: 12 weeks
Efficiency after 24 weeks of treatment with Romiplostim N01
Time frame: 24 weeks
Platelet counts at each visit point
Time frame: 24 weeks
WHO bleeding scale at each visit point
Time frame: 24 weeks
Adverse events
Time frame: 24 weeks
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 14 Jul 2025.
- Individual participant dataSharing planned: Yes. Researchers qualified can request the dataset, including de-identified individual subject data. Data may be requested from PI from 12 months to 36 months after study completion.
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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.
Yunfei Chen, MD principal investigator
Chinese Academy of Medical Science and Blood Disease Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Romiplostim N01 in people with Chemotherapy-induced Thrombocytopenia and Romiplostim N01, run by Institute of Hematology & Blood Diseases Hospital, China 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 10 inclusion and 14 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 14 Jul 2025. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Ting Sun, MD (+8615822339131, sunting@ihcams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficiency after 12 weeks of treatment with Romiplostim N01 (time frame: 12 weeks). 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 14 Jul 2025.