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Compares treatment options for Primary Immune Thrombocytopenia (ITP)
Official title Eltrombopag Combining Rituximab Versus Eltrombopag in the Management of Primary Immune Thrombocytopenia (ITP) in Adults
ClinicalTrials.gov ID: NCT04518475
What this study is testing
What is eltrombopag combining rituximab?
eltrombopag combining rituximab is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for primary immune thrombocytopenia (itp).
Also referred to as TPO-R agonist & anti-CD20 antibody.
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 multicenter randomized, open-label study aimed to compare the efficacy and safety of eltrombopag combining rituximab with eltrombopag in China adult ITP patients .This study was be conducted in adult ITP patients who had not responded to or had relapsed after previous treatment of ITP, including first line therapy and /or splenectomy.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
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 60
You may be able to join if
- Signed written informed consent
- Age from 18 to 60 years old
- Diagnosed with ITP and have a platelet count of \<30 ×10\^9/L on Day 1 (or within 48 hours prior to dosing on Day 1).
- Patients who have no response or relapsed after splenectomy(at least more than 6 months). Or patients who have not been splenectomised and have...
- people treated with previous therapy(including but not limited to corticosteroid, azathioprine, danazol, cyclosporin A, mycophenolate mofetil) must...
You likely can't join if
- Patients with any prior history of arterial or venous thrombosis, and with following risk factors: cancer, Factor V Leiden, ATIII deficiency...
- Pregnant or lactating women;
- people is currently receiving treatment with another study medication.
- Any laboratory or clinical evidence for HIV infection.
- Any clinical history for hepatitis C infection; chronic hepatitis B infection; or any evidence for active hepatitis at the time of subject screening...
- History of platelet aggregation that prevents reliable measurement of platelet counts.
See the full eligibility criteria
- Signed written informed consent
- Age from 18 to 60 years old
- Diagnosed with ITP and have a platelet count of \<30 ×10\^9/L on Day 1 (or within 48 hours prior to dosing on Day 1).
- Patients who have no response or relapsed after splenectomy(at least more than 6 months). Or patients who have not been splenectomised and have either not responded to one or more prior therapies, or who have relapsed...
- people treated with previous therapy(including but not limited to corticosteroid, azathioprine, danazol, cyclosporin A, mycophenolate mofetil) must have been completed prior to randomization, or must not be increasing a...
- No pre-existing cardiac disease within the last 3 months. No arrhythmia known to increase the risk of thrombolic events (e.g. atrial fibrillation), or patients with a Corrected QT interval (QTc) \>450msec or QTc \>480...
- No pre-existing infection within the last 1 months(including but not limited to pulmonary infection)
- Laboratory tests for coagulation function showed that prothrombin time (PT/INR) and activated partial thromboplastin time (APTT) no exceed normal by more than 20%. No history of clotting disorder, other than ITP.
- White blood cell count, neutrophil absolute value, hemoglobin, within the reference range, with the following exceptions:
- Hemoglobin: females and males 10.0 g/dl are eligible for inclusion,
- Absolute neutrophil count (ANC) ≥1500/µL (1.5×109/L) is required for inclusion
- The following blood chemistry test result no exceed normal by more than 20%:alanine aminotransferase, aspartate aminotransferase, total bilirubin, creatinine,serum albumin must not be below the lower limit of normal...
- Subject is non-childbearing potential of childbearing potential and use acceptable methods of contraception throughout the study.
- people fully understand and are able to comply with the requirements of the research protocol and are willing to complete the study as planned.
- Patients with any prior history of arterial or venous thrombosis, and with following risk factors: cancer, Factor V Leiden, ATIII deficiency, antiphospholipid syndrome.
- Pregnant or lactating women;
- people is currently receiving treatment with another study medication.
- Any laboratory or clinical evidence for HIV infection.
- Any clinical history for hepatitis C infection; chronic hepatitis B infection; or any evidence for active hepatitis at the time of subject screening. Laboratory test shows positive serology for Hepatitis C or Hepatitis...
- History of platelet aggregation that prevents reliable measurement of platelet counts.
- Any clinically relevant abnormality, other than ITP,which in the opinion of the investigator makes the subject unsuitable for participation in the study.
The study team makes the final eligibility decision.
Where it's taking place
- Tianjin, 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 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tianjin, 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.