Active — Not RecruitingPhase 2

A Multicenter Randomized Open-label Study of Diammonium Glycyrrhizinate Enteric-coated Capsule Plus DXM Versus DXM in Treatment of ITP

China106 participantsStarted 2021-08-21

Plain-language summary

The project was undertaking by Qilu Hospital of Shandong University in China. In order to report the efficacy and safety of diammonium glycyrrhizinate enteric-coated capsule plus high-dose dexamethasone for the treatment of adults with newly-diagnosed primary immune thrombocytopenia (ITP).

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Meet the diagnostic criteria for immune thrombocytopenia; * Untreated hospitalized patients or patients from the clinic, may be male or female, between the ages of 18\~ 80 years; * To show a platelet count \<30 \* 10\^9/L, or with bleeding manifestations, or both; * Willing and able to sign written informed consent * ITP patients with hepatitis virus infection or ITP patients with abnormal liver function at the time of enrollment, i.e., ITP patients with indications for diammonium glycyrrhizinate enteric-coated capsule, should be separately stratified. Exclusion Criteria: * secondary thrombocytopenia; * severe immune-deficiency; * active or previous malignancy; * HIV virus infection, tuberculosis, or other active infection (sepsis, pneumonia, or abscess); * pregnancy or lactation; * diabetes; * hypertension; * cardiovascular diseases; * severe kidney function impairment; * psychosis; * osteoporosis; * inflammatory bowel disease or gastric disease; * arterial or venous thromboembolism within the 6 months before screening or patients who required anticoagulant treatment; * an organ or haematopoietic stem-cell transplantation; * neutrophil count of less than 1500 cells per mm³; * glycosylated haemoglobin less than 8%; * partial thromboplastin time 1∙5 times or less the upper limit of normal (ULN); •clinical electrocardiogram changes; * history of primary immunodeficiency; * neoplastic disease within the past 5 years; * corrected QT interval greater than …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

14-day initial overall response to ITP treatments

Timeframe: 14 days after treatment started

6-month sustained overall response to ITP treatments

Timeframe: A response lasting for at least 6 months without any additional intervention specific to primary immune thrombocytopenia was defined as a sustained response

Trial details

NCT IDNCT05023915

SponsorShandong University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-08-21

View on ClinicalTrials.gov More Immune Thrombocytopenia trials