Actively Recruiting
Romiplostim N01 for Chemotherapy-induced Thrombocytopenia
Led by Institute of Hematology & Blood Diseases Hospital, China · Updated on 2025-07-14
50
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
I
Institute of Hematology & Blood Diseases Hospital, China
Lead Sponsor
T
Tianjin Medical University Cancer Institute and Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
To evaluate the efficacy and safety of Romiplostim N01 to treat chemotherapy-induced thrombocytopenia in tumors
CONDITIONS
Official Title
Romiplostim N01 for Chemotherapy-induced Thrombocytopenia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or above, any gender
- Diagnosed with chemotherapy-related thrombocytopenia and ineffective after repeated treatment with rhTPO or IL-11
- Received at least 14 days of rhTPO treatment at 300u/kg/day or higher with platelet count less than 30 x 10^9/L (refractory CTIT)
- Stopped chemotherapy and radiotherapy for more than 1 month
- Platelet count less than 30 x 10^9/L at enrollment
- Platelet count remains less than 30 x 10^9/L for more than 1 month
- Expected survival period of at least 6 months
- Liver and kidney function less than 1.5 times the upper limit of normal
- Physical examination qualified
- ECOG physical status score of 2 or below
- New York Heart Association cardiac function grade 2 or below
- Voluntary signed informed consent form
You will not qualify if you...
- Uncontrollable primary diseases of important organs such as extensive malignant tumor metastasis, liver failure, heart failure, kidney failure
- Poor compliance
- Positive serology for HIV, HBV, HCV, HDV, Syphilis; positive for Epstein-Barr Virus DNA or Cytomegalovirus DNA
- Extensive and severe bleeding such as hemoptysis, upper gastrointestinal bleeding, intracranial hemorrhage
- Current heart disease requiring treatment or poorly controlled hypertension
- Thrombotic diseases including pulmonary embolism, thrombosis, atherosclerosis
- Past allogeneic stem cell transplantation or organ transplantation
- Mental disorders preventing informed consent or trial participation
- Toxic symptoms from previous treatments not resolved
- Other serious diseases restricting trial participation (e.g., diabetes, severe heart failure, unstable arrhythmia or angina, gastric ulcers, autoimmune diseases)
- Sepsis or irregular bleeding
- Concurrent use of antiplatelet drugs
- Pregnant, suspected pregnancy, or breastfeeding
- Pre-existing cardiac disease including NYHA Grade III/IV heart failure, recent myocardial infarction, or arrhythmias requiring treatment
- Investigator's judgment that participation is unsuitable
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Chinese Academy of Medical Science and Blood Disease Hospital
Tianjin, Tianjin Municipality, China, 301600
Actively Recruiting
Research Team
T
Ting Sun, MD
CONTACT
Y
Yunfei Chen, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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