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New treatment option for Primary Immune Thrombocytopenic Purpura
Official title TPO-RA in Primary Immune Thrombocytopenia (ITP) in Patients Older Than 14 Years
ClinicalTrials.gov ID: NCT04890041
What this study is testing
What is TPO-RA?
TPO-RA is an investigational medicine, given as an once-weekly, being studied as a potential treatment for primary immune thrombocytopenic purpura.
Also referred to as TPO-RAs.
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 multi-center study aims to study the efficacy of TPO-RAs' transformation in Chinese ITP patients older than 14 years. This study will be conducted in ITP patients who had not responded to first-line in the previous treatment .
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 14 and older
You may be able to join if
- Men and women greater than or equal to 14 years of age.
- Participants diagnosed with primary immune thrombocytopenia with two platelet counts of \< 30x10\^9/L or with bleeding at least 7 days apart，do not...
- Previous treatment with poor response to first-line therapy and any of the maximum 4-week doses of eltrombopag, herombopag, avatrombopag, or 300U/kg/...
- Participants willing and able to comply with the requirements of the study protocol, and sign the informed consent.
You likely can't join if
- Patients diagnosed with secondary immune thrombocytopenia.
- A history of arteriovenous thrombosis, disseminated intravascular coagulation, myocardial infarction, cerebral obstruction, thrombotic...
- Liver disease with one of the following indicators: a. total bilirubin ≥ 2 times of the upper limit of normal; b. alanine aminotransferase (ALT) and...
- people with known allergies to eltrombopag, herombopag, rh-TPO, avatrombopag, or any of excipients;
- Have used rituximab in the past 3 months;
- Splenectomy in recent 3 months;
See the full eligibility criteria
- Men and women greater than or equal to 14 years of age.
- Participants diagnosed with primary immune thrombocytopenia with two platelet counts of \< 30x10\^9/L or with bleeding at least 7 days apart，do not have evidence of other causes of thrombocytopenia...
- Previous treatment with poor response to first-line therapy and any of the maximum 4-week doses of eltrombopag, herombopag, avatrombopag, or 300U/kg/ day × 14-day rhTPO with no response to treatment (platelet count \<...
- Participants willing and able to comply with the requirements of the study protocol, and sign the informed consent.
- Patients diagnosed with secondary immune thrombocytopenia.
- A history of arteriovenous thrombosis, disseminated intravascular coagulation, myocardial infarction, cerebral obstruction, thrombotic microangiopaemia, autoimmune diseases, malignant tumors, liver cirrhosis and other...
- Liver disease with one of the following indicators: a. total bilirubin ≥ 2 times of the upper limit of normal; b. alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≥ 2 times the upper limit of normal...
- people with known allergies to eltrombopag, herombopag, rh-TPO, avatrombopag, or any of excipients;
- Have used rituximab in the past 3 months;
- Splenectomy in recent 3 months;
- Those who are not considered suitable for this study by the researcher;
- Women who are pregnant or who intend to become pregnant in the near future are excluded.
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, 14 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.