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New treatment option for Primary Immune Thrombocytopenia
Official title A Study of Romiplostim N01 as the First-line Treatment for Newly Diagnosed Adult Patients With ITP
ClinicalTrials.gov ID: NCT06658834
What this study is testing
What is Dexamethasone Combined with romiplostim N01?
Dexamethasone Combined with romiplostim N01 is an investigational medicine, given as an once-weekly injection under the skin, being studied as a potential treatment for primary immune 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
- This study is a multicenter interventional research on the first-line treatment of newly diagnosed adult patients with immune thrombocytopenia (ITP) using romiplostim N01 in combination with glucocorticoids. The primary endpoint of this study is to assess the efficacy of romiplostim N01 combined with glucocorticoids in untreated newly diagnosed adult ITP patients after 6 months of administration.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 6 months
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Sign the written informed consent form before enrollment;
- Age ranging from 18 to 75 years old;
- Be clinically diagnosed with primary immune thrombocytopenia for less than 3 months before randomization;
- Have not received splenectomy or at least one first-line ITP treatment or emergency treatment in the past;
- Have not received romiplostim treatment;
You likely can't join if
- Suffering from other hematopoietic system diseases except ITP, including but not limited to leukemia, thrombocytopenia caused by tumor treatment...
- Having undergone splenectomy before the first administration;
- Having received ITP drug treatment (including emergency treatment) before the first administration;
- Having used drugs with c-Mpl (thrombopoietin receptor) stimulating effects within 4 weeks before the first administration;
- Having received hematopoietic growth factor preparations (such as granulocyte colony-stimulating factor, macrophage colony-stimulating factor...
- Having received antibody drugs (such as rituximab, etc.) within 14 weeks before the first administration;
See the full eligibility criteria
- Sign the written informed consent form before enrollment;
- Age ranging from 18 to 75 years old;
- Be clinically diagnosed with primary immune thrombocytopenia for less than 3 months before randomization;
- Have not received splenectomy or at least one first-line ITP treatment or emergency treatment in the past;
- Have not received romiplostim treatment;
- ECOG PS score: 0 - 2;
- Platelet value \< 30×10\^9/L;
- The expected survival period at the screening is ≥ 12 weeks;
- For people of reproductive age, agree to take reliable contraceptive measures throughout the study period (including male or female condoms, contraceptive foams, contraceptive gels, contraceptive membranes...
- Voluntarily join this study, sign the informed consent form, and have good compliance.
- Suffering from other hematopoietic system diseases except ITP, including but not limited to leukemia, thrombocytopenia caused by tumor treatment, myeloproliferative diseases, multiple myeloma and myelodysplastic...
- Having undergone splenectomy before the first administration;
- Having received ITP drug treatment (including emergency treatment) before the first administration;
- Having used drugs with c-Mpl (thrombopoietin receptor) stimulating effects within 4 weeks before the first administration;
- Having received hematopoietic growth factor preparations (such as granulocyte colony-stimulating factor, macrophage colony-stimulating factor, erythropoietin, interleukin-11, etc.) within 4 weeks before the first...
- Having received antibody drugs (such as rituximab, etc.) within 14 weeks before the first administration;
- Having received any Chinese herbal medicine or nutritional supplement (except vitamin supplements and mineral supplements) for the purpose of increasing platelets within 1 week before the first administration;
- Having been diagnosed with arterial thrombosis (such as cerebral thrombosis, transient ischemic attack or myocardial infarction), or having a history or complication of venous thrombosis (such as deep vein thrombosis...
- Having a history of severe cardiovascular diseases (such as grade III/IV congestive heart failure, arrhythmia or angina pectoris that increases the risk of thromboembolic events, unstable angina pectoris, having...
- Secondary thrombocytopenia caused by autoimmune diseases such as antiphospholipid antibody syndrome, systemic lupus erythematosus, Hashimoto's thyroiditis, Even's syndrome and Sjogren's syndrome;
- Positive results for either human immunodeficiency virus antibody or syphilis antibody screening; positive hepatitis C antibody and HCV-RNA exceeding the upper limit of the study center's laboratory test; positive...
- Having participated in other clinical studies within 3 months before the first administration;
- Being pregnant or lactating, or having a pregnancy plan;
- Having fertility and being judged by the researcher as not fully adopting contraceptive measures;
- Having a history of severe drug allergic reactions or being known to be allergic to glucocorticoids or Nplate® (romiplostim) or the components of QL0911;
- Unable to comply for mental reasons;
- Judged by the researcher as not suitable to participate in this trial;
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 study runs about 6 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. 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.