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New treatment option for Chemotherapy-induced Thrombocytopenia
Official title Romiplostim N01 for Chemotherapy-induced Thrombocytopenia
ClinicalTrials.gov ID: NCT07063225
What this study is testing
What is Romiplostim N01?
Romiplostim N01 is an investigational medicine, given as an once-weekly injection under the skin, being studied as a potential treatment for chemotherapy-induced thrombocytopenia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- To evaluate the efficacy and safety of Romiplostim N01 to treat chemotherapy-induced thrombocytopenia in tumors
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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...
- 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;
You likely can't join if
- Those with uncontrollable primary diseases of important organs, such as extensive metastasis of malignant tumors, liver failure, heart failure...
- 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...
- 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；
See the full eligibility criteria
- 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 (people need to undergo regular rhTPO treatment for at least 14...
- 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;
- 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...
- 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...
- Researchers believe that patients should not participate in the test of any other condition.
The study team makes the final eligibility decision.
Where it's taking place
- Tianjin, Tianjin Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tianjin, Tianjin Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.