A Phase 2 interventional study of Romiplostim N01 in Thrombocytopenia Chemotherapy Induced, sponsored by Fudan University. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-08-18.
Sponsored by Fudan University · Phase 2, Interventional, and Supportive care
Among 41 studies testing romiplostim in Thrombocytopenia — 9 open to participants now, 9 under way, 3 of them phase 3. romiplostim · Thrombocytopenia.
Among the 41 studies testing romiplostim in Thrombocytopenia, this one is the 25th largest by planned enrollment, is one of 3 that started in 2026, is one of 20 in phase 2, and was the 40th registered.
482 studies on the registry are indexed under Thrombocytopenia; 100 are open to participants now.
Browse Thrombocytopenia studies →9 of the 41 studies testing romiplostim in Thrombocytopenia are open now, in 3 countries. Recruiting first, the newest first:
Nantes University Hospital · Sites in France
Institute of Hematology & Blood Diseases Hospital, China · Sites in China
Anhui Provincial Hospital · Sites in China
The First Affiliated Hospital with Nanjing Medical University · Sites in China
Ain Shams University · Sites in Egypt
By country, each count listing its studies:
romiplostim: first FDA approval 2008 (NPLATE), first EMA approval 2009. What it is approved for, and how studies give it, is on its page →
Of the 66 Thrombocytopenia studies recruiting now, 44 (67%) set no upper age limit and 18 (27%) stop at 75 or younger; 10 take children under 18; 3 take healthy volunteers.
This study: 18 Years to 75 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
41 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 5 · Phase 2 24 · Phase 3 13 · Phase 4 1
First in 2002; this study’s year is marked. 3 started in 2026.
This study's planned enrollment of 53 is close to the median of 54 across 334 interventional studies indexed under Thrombocytopenia.
Median enrollment 62 across the 41 interventional studies. Of the 29 that completed or were terminated, 20 (69%) have results posted.
This tab as a report to print or save as PDF → With an account.
21 of 41 have an industry lead sponsor. The 10 most frequent:
Fudan University is the lead sponsor of 1,315 studies on the registry; 643 are open to participants now.
Fudan University has 4 studies filed under Thrombocytopenia — fewer than ten, so there is no comparison to draw.
1 of the studies testing romiplostim in Thrombocytopenia that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06898983Anhui Provincial HospitalEfficacy and Safety Study of Romiplostim N01 for Cancer Treatment-induced Thrombocytopenia (CTIT) in the Treatment of Leukemia | 2027-01-31 |
Among the 41 studies testing romiplostim in Thrombocytopenia, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
This study aims to evaluate the efficacy and safety of Romiplostim N01 for Injection administered as secondary prophylaxis in breast cancer patients with chemotherapy-induced thrombocytopenia (CIT).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Romiplostim N01 for Injection
Drug: Romiplostim N01
Romiplostim N01 for Injection: 3.0 µg/kg, QW. If the administration coincides with a chemotherapy day, the Romiplostim N01 for injection should be completed within 2 hours prior to chemotherapy. If no chemotherapy is scheduled on the planned dosing day, the injection timing is unrestricted. Thereafter, platelet counts should be monitored once or twice weekly. Subsequent dose adjustments follow the principle of guideline-based titration: when platelet count is \<50×10⁹/L, the dose is increased by 1-2 µg/kg per week; when platelet count is between 50×10⁹/L and 75×10⁹/L, the dose is increased by 1 µg/kg per week. Treatment should be discontinued if Romiplostim N01 for injection at 10 µg/kg administered weekly for 4 consecutive weeks fails to achieve a response. Non-response is defined as a platelet count ≤75×10⁹/L after 4 weeks of continuous administration, accompanied by an increase from baseline of ≤30×10⁹/L over the same period.
Proportion of patients achieving response
Defined as platelet recovery over two consecutive cycles, with no dose modification (≥15% reduction, ≥4-day delay, or discontinuation) due to thrombocytopenia, and no rescue treatment.
Time frame: up to the completion of two consecutive treatment cycles, an average of 6 weeks
Proportion of patients with platelet count <50×10⁹/L per cycle
Proportion of patients with platelet count \<50×10⁹/L per cycle
Time frame: until the end of each treatment cycle, an average of 3 weeks
Minimum and maximum platelet counts
To evaluate the minimum and maximum platelet counts throughout the entire treatment period.
Time frame: through study completion, an average of 1year
Number of symptomatic bleeding episodes during the treatment period
Number of symptomatic bleeding episodes during the treatment period
Time frame: through study completion, an average of 1year
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time frame: through study completion, an average of 1year
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Aug 2026; primary completion for Apr 2028, 20 months later.
Of 44 non-industry phase 2 interventional studies under Thrombocytopenia, half reached primary completion within 63 months of starting (the median), counting those still running; a quarter within 33 and three quarters within 83. This study's planned 20 months is below that.
Counting every sponsor, half of 54 studies reached it within 36 months; a quarter within 28 and three quarters within 81.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Romiplostim