Immune ThrombocytopeniaPhase 2NCT05023915
A Multicenter Randomized Open-label Study of Diammonium Glycyrrhizinate Enteric-coated Capsule Plus DXM Versus DXM in Treatment of ITP
A Phase 2 study testing dexamethasone and diammonium glycyrrhizinate enteric-coated capsule in people with Immune Thrombocytopenia, run by Shandong University at 2 sites in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Immune Thrombocytopenia
- What is being tested?
- dexamethasone and diammonium glycyrrhizinate enteric-coated capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 2 sitesChina
- Study dates
- 21 Aug 2021to 31 Jan 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 22Show fewer
- 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 450 ms for men and greater than 470 ms for women;
- substance misuse within the previous 12 months;
- people who could not adhere to the protocol or were planning to have a surgical procedure in 6 months.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Qilu hospital, Shandong University
Jinan, Shandong, 250000
Qilu hospital (Qingdao), Shandong University
Qingdao, Shandong, 266000
About this study
Official title: High-dose Dexamethasone Plus Diammonium Glycyrrhizinate Enteric-coated Capsule Versus High-dose Dexamethasone in Treatment-naive Primary Immune Thrombocytopenia (ITP): a Multicentre, Randomised, Open-label Trial
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).
Read the detailed description
The investigators anticipate to undertaking a parallel group, randomised controlled trial of 106 ITP patients. One part of the participants are randomly selected to receive diammonium glycyrrhizinate enteric-coated capsule orally at a dose of 150mg tid for 1 month), combining with dexamethasone (given orally at a dose of 40 mg qd for 4 days). The others are selected to receive high-dose of dexamethasone alone. Patients who do not respond to the treatment may receive another cycle of high-dose dexamethasone therapy with an interval of 10 days. Platelet count, bleeding and other symptoms were evaluated before and after treatment. Adverse events are also recorded throughout the study. The purpose of this study is to report the efficacy and safety of diammonium glycyrrhizinate enteric-coated capsule combining with high-dose dexamethasone therapy for the treatment of ITP.
- Conditions
- Immune Thrombocytopenia
- Being tested
- dexamethasone, diammonium glycyrrhizinate enteric-coated capsule
- Keywords
- Dexamethasone, Diammonium Glycyrrhizinate Enteric-coated Capsule
- Medical subject headings
- Purpura, Thrombocytopenic, Idiopathic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dexamethasoneDrug
40 mg qd for 4 days
diammonium glycyrrhizinate enteric-coated capsuleDrug
150mg tid for 1 month
| Study group | Role | What they receive |
|---|---|---|
| diammonium glycyrrhizinate enteric-coated capsule + high-dose dexamethasone | Active comparator | Diammonium glycyrrhizinate enteric-coated capsule orally at a dose of 150mg tid for 1 month, combining with dexamethasone (given orally at a dose of 40 mg qd for 4 days). Patients who do not respond to the treatment may receive another cycle of high-dose dexamethasone therapy with an interval of 10 days. Receives: Drug: dexamethasone; Drug: diammonium glycyrrhizinate enteric-coated capsule |
| High-dose dexamethasone | Active comparator | Dexamethasone orally at a dose of 40 mg qd for 4 days. Patients who do not respond to the treatment may receive another cycle of high-dose dexamethasone therapy with an interval of 10 days. Receives: Drug: dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
14-day initial overall response to ITP treatments
Complete response was defined as a platelet count of 100×10⁹ cells per L or higher and an absence of bleeding. Partial response was defined as a platelet count of 30×10⁹ cells per L or higher, but less than 100×10⁹ cells per L, and at least a doubling of the baseline platelet count and an absence of bleeding. Platelet counts were confirmed on two separate occasions at least 7 days apart when defining complete response or partial response. No response was defined as a platelet count of less than 30×10⁹ cells per L, or less than two-times increase from baseline platelet count, or bleeding.
Measured: 14 days after treatment started
6-month sustained overall response to ITP treatments
Complete response was defined as a platelet count of 100×10⁹ cells per L or higher and an absence of bleeding. Partial response was defined as a platelet count of 30×10⁹ cells per L or higher, but less than 100×10⁹ cells per L, and at least a doubling of the baseline platelet count and an absence of bleeding. Platelet counts were confirmed on two separate occasions at least 7 days apart when defining complete response or partial response. No response was defined as a platelet count of less than 30×10⁹ cells per L, or less than two-times increase from baseline platelet count, or bleeding.
Measured: A response lasting for at least 6 months without any additional intervention specific to primary immune thrombocytopenia was defined as a sustained response
Secondary outcomes (3)
time to response
the time from treatment initiation to achieve a complete response or a partial response
Measured: an average of 6 months
duration of response
the time from achievement of a complete response or a partial response to the loss of response (platelet count <30×10⁹ cells per L; measured on two occasions more than 1 day apart or the presence of bleeding).
Measured: through study completion, an average of one year
therapy associated adverse events
nausea and diarrhea (report in frequency); pruritus (report in frequency); headache and dizziness (report in frequency)
Measured: up to one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2021
- Study start21 Aug 2021
- Primary completion21 Aug 2021
- Study completion31 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Immune ThrombocytopeniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 106 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ming Hou, Shandong University
- Investigators
- Ming Hou, MD,PhD, Principal investigator, Shandong University Qilu Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05023915
- Sponsor's protocol ID
- ITP-Diammonium Glycyrrhizinate
- Status last verified
- Jan 2026
- First submitted
- 21 Aug 2021
- Last updated
- 26 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wang H, Wang R, Yuan C, Bi K, Xiao T, Teng Q, Wang H, Yu J, Hou M, Hou Y. A multicentre randomized open-label phase 2 trial of dexamethasone plus glycyrrhizinate versus dexamethasone in newly diagnosed immune thrombocytopenia. Br J Haematol. 2026 Aug;209(2):682-690. doi: 10.1111/bjh.70574. Epub 2026 May 24.
PubMed 42178778
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-dose Dexamethasone Plus Diammonium Glycyrrhizinate Enteric-coated Capsule Versus High-dose Dexamethasone in Treatment-naive Primary Immune Thrombocytopenia (ITP): a Multicentre, Randomised, Open-label Trial
- ClinicalTrials.gov ID
- NCT05023915
- Acronym / sponsor ID
- ITP-Diammonium Glycyrrhizinate
- Conditions
- Immune Thrombocytopenia
- Keywords
- Dexamethasone, Diammonium Glycyrrhizinate Enteric-coated Capsule
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 106 participants (estimated)
- Lead sponsor
- Shandong UniversityUniversity, hospital or other
- Study start
- 21 Aug 2021 (actual)
- Primary completion
- 21 Aug 2021 (actual)
- Study completion
- 31 Jan 2026 (estimated)
- First posted
- 27 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
The investigators anticipate to undertaking a parallel group, randomised controlled trial of 106 ITP patients. One part of the participants are randomly selected to receive diammonium glycyrrhizinate enteric-coated capsule orally at a dose of 150mg tid for 1 month), combining with dexamethasone (given orally at a dose of 40 mg qd for 4 days). The others are selected to receive high-dose of dexamethasone alone. Patients who do not respond to the treatment may receive another cycle of high-dose dexamethasone therapy with an interval of 10 days. Platelet count, bleeding and other symptoms were evaluated before and after treatment. Adverse events are also recorded throughout the study. The purpose of this study is to report the efficacy and safety of diammonium glycyrrhizinate enteric-coated capsule combining with high-dose dexamethasone therapy for the treatment of ITP.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| diammonium glycyrrhizinate enteric-coated capsule + high-dose dexamethasone | Active comparator | Drug: dexamethasone, Drug: diammonium glycyrrhizinate enteric-coated capsuleDiammonium glycyrrhizinate enteric-coated capsule orally at a dose of 150mg tid for 1 month, combining with dexamethasone (given orally at a dose of 40 mg qd for 4 days). Patients who do not respond to the treatment may receive another cycle of high-dose dexamethasone therapy with an interval of 10 days. |
| High-dose dexamethasone | Active comparator | Drug: dexamethasoneDexamethasone orally at a dose of 40 mg qd for 4 days. Patients who do not respond to the treatment may receive another cycle of high-dose dexamethasone therapy with an interval of 10 days. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (22 listed)
- secondary thrombocytopenia;
- severe immune-deficiency;
- active or previous malignancy;
- HIV virus infection, tuberculosis, or other active infection (sepsis, pneumonia, or abscess);
- pregnancy or lactation;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dexamethasone40 mg qd for 4 days | Drug | High-dose dexamethasone, diammonium glycyrrhizinate enteric-coated capsule + high-dose dexamethasone |
| diammonium glycyrrhizinate enteric-coated capsule150mg tid for 1 month | Drug | diammonium glycyrrhizinate enteric-coated capsule + high-dose dexamethasone |
Primary outcome
14-day initial overall response to ITP treatments
Time frame: 14 days after treatment started
Complete response was defined as a platelet count of 100×10⁹ cells per L or higher and an absence of bleeding. Partial response was defined as a platelet count of 30×10⁹ cells per L or higher, but less than 100×10⁹ cells per L, and at least a doubling of the baseline platelet count and an absence of bleeding. Platelet counts were confirmed on two separate occasions at least 7 days apart when defining complete response or partial response. No response was defined as a platelet count of less than 30×10⁹ cells per L, or less than two-times increase from baseline platelet count, or bleeding.
6-month sustained overall response to ITP treatments
Time frame: A response lasting for at least 6 months without any additional intervention specific to primary immune thrombocytopenia was defined as a sustained response
Complete response was defined as a platelet count of 100×10⁹ cells per L or higher and an absence of bleeding. Partial response was defined as a platelet count of 30×10⁹ cells per L or higher, but less than 100×10⁹ cells per L, and at least a doubling of the baseline platelet count and an absence of bleeding. Platelet counts were confirmed on two separate occasions at least 7 days apart when defining complete response or partial response. No response was defined as a platelet count of less than 30×10⁹ cells per L, or less than two-times increase from baseline platelet count, or bleeding.
3 secondary outcomes
time to response
Time frame: an average of 6 months
duration of response
Time frame: through study completion, an average of one year
therapy associated adverse events
Time frame: up to one year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2026.
- Derived from this study: PubMed 42178778Wang H, Wang R, Yuan C, Bi K, Xiao T, Teng Q, Wang H, Yu J, Hou M, Hou Y. A multicentre randomized open-label phase 2 trial of dexamethasone plus glycyrrhizinate versus dexamethasone in newly diagnosed immune thrombocytopenia. Br J Haematol. 2026 Aug;209(2):682-690. doi: 10.1111/bjh.70574. Epub 2026 May 24.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ming Hou, MD,PhD principal investigator
Shandong University Qilu Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing dexamethasone and diammonium glycyrrhizinate enteric-coated capsule in people with Immune Thrombocytopenia, run by Shandong University at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 26 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
14-day initial overall response to ITP treatments (time frame: 14 days after treatment started). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05023915, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2026.