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New treatment option for Primary Immune Thrombocytopenia
Official title Study on Glucocorticoid Combined With Gamma Globulin and Ropristine N01 in Treatment of Initial Severe ITP
ClinicalTrials.gov ID: NCT06686927
What this study is testing
What is corticosteroids combined with immunoglobulin and romiplostim?
corticosteroids combined with immunoglobulin and romiplostim 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
- The goal of this clinical trial is to learn if romiplostim N01 works to treat severe primary immune thrombocytopenia in adults. It will also learn about the safety of romiplostim N01.
- 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 to 75
You may be able to join if
- Participants must sign a written informed consent prior to enrollment;
- Ages 18-75;
- Platelet count \<10×10\^9/L with active bleeding or bleeding score ≥5;
- No contraindications to the use of steroids, romiplostim, or IVIG, and willingness to receive these treatments;
- No prior splenectomy or at least one first-line ITP treatment or emergency treatment;
You likely can't join if
- Individuals with the following hematological disorders other than ITP, including but not limited to leukemia, thrombocytopenia caused by cancer...
- Individuals with a history of thrombosis;
- Pregnant or lactating individuals;
- Individuals with severe cardiopulmonary insufficiency;
- Individuals with severe or uncontrollable infections;
- Individuals with viral infections;
See the full eligibility criteria
- Participants must sign a written informed consent prior to enrollment;
- Ages 18-75;
- Platelet count \<10×10\^9/L with active bleeding or bleeding score ≥5;
- No contraindications to the use of steroids, romiplostim, or IVIG, and willingness to receive these treatments;
- No prior splenectomy or at least one first-line ITP treatment or emergency treatment;
- No prior romiplostim treatment;
- ECOG PS score: 0-2;
- Female participants of childbearing potential must agree to use reliable contraception (including male or female condoms, contraceptive foam, contraceptive jelly, contraceptive patches, contraceptive cream...
- Voluntary participation in this study and good compliance.
- Individuals with the following hematological disorders other than ITP, including but not limited to leukemia, thrombocytopenia caused by cancer treatment, myeloproliferative diseases, multiple myeloma, and...
- Individuals with a history of thrombosis;
- Pregnant or lactating individuals;
- Individuals with severe cardiopulmonary insufficiency;
- Individuals with severe or uncontrollable infections;
- Individuals with viral infections;
- Individuals who cannot comply due to psychological reasons;
- Individuals who are deemed unsuitable for participation in the study by the investigator.
The study team makes the final eligibility decision.
Where it's taking place
- Wuhan, Hubei, 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 to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Wuhan, Hubei, 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.