Romiplostim N01 for Chemotherapy-induced Thrombocytopenia

NCT07063225 | Recruiting Phase 2 DMC

• 1 other identifier: IIT2025061
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the efficacy and safety of Romiplostim N01 to treat chemotherapy-induced thrombocytopenia in tumors

Conditions

Chemotherapy-induced Thrombocytopenia; Romiplostim N01

Outcome Measures

Primary Outcomes (1)

• 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.

  12 weeks

Secondary Outcomes (5)

• Other efficacy evaluation after 12 weeks of treatment with Romiplostim N01

  12 weeks

• Efficiency after 24 weeks of treatment with Romiplostim N01

  24 weeks

• Platelet counts at each visit point

  24 weeks

• WHO bleeding scale at each visit point

  24 weeks

• Adverse events

  24 weeks

Study Arms (1)

Romiplostim N01

EXPERIMENTAL

50 enrolled subjects will be picked up to take Romiplostim N01 at the indicated dose.

Drug: Romiplostim N01

Interventions

Romiplostim N01 DRUG

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.

Romiplostim N01

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• 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;

You may not qualify if:

• 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；
• 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.

Sponsors & Collaborators

• Institute of Hematology & Blood Diseases Hospital, China: lead
• Tianjin Medical University Cancer Institute and Hospital: collaborator
• Tianjin Medical University Second Hospital: collaborator
• Tianjin Third Central Hospital: collaborator
• Tianjin People's Hospital: collaborator
• Henan Cancer Hospital: collaborator
• The Second Affiliated Hospital of Kunming Medical University: collaborator

Study Sites (1)

Chinese Academy of Medical Science and Blood Disease Hospital

Tianjin, Tianjin Municipality, 301600, China

RECRUITING

Study Officials

• Yunfei Chen, MD

  Chinese Academy of Medical Science and Blood Disease Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ting Sun, MD

CONTACT

+8615822339131; sunting@ihcams.ac.cn

Yunfei Chen, MD

CONTACT

8618502220788; henyunfei@ihcams.ac.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2025
• First Posted: July 14, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: July 14, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, ICF
• Time Frame: 12 months to 36 months after study completion.
• Access Criteria: Upon request to PI.

Locations

CN (1)