ThrombocytopeniaPhase 2/3NCT06913374
The Study of Different Cycles of High-dose Dexamethasone in the Treatment of ITP
A Phase 2/3 study testing Dexamethasone in people with Thrombocytopenia, run by Shandong University at 1 site in China.
Trial summary
Primary immune thrombocytopenia is an autoimmune disorder characterised by decreased platelet counts and increased bleeding risk. Corticosteroids have been the standard initial treatment of primary immune thrombocytopenia for more than 30 years. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thrombocytopenia
- What is being tested?
- Dexamethasone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2025to 30 May 2027
- Phase
- Phase 2/3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant must be at least 18 years of age at the time of the screening.
- Participant may be male or female.
- Participant has a confirmed diagnosis of newly diagnosed ITP according to the 2019 International Working Group assessment at screening, and has a baseline platelet count of less than 30 × 10^9 cells per L or had bleeding manifestations, or both.
Who cannot join
- Participant has evidence of a secondary cause of immune thrombocytopenia (e.g. leukemia, lymphoma, common variable immune- deficiency, systemic lupus erythematosus, autoimmune thyroid disease, past medical history of untreated H. pylori infection) or to drug treatments (e.g. heparin, quinine, antimicrobials, anticonvulsants) or participant has a multiple immune cytopenia, e.g. Evan's syndrome.
- Participant has clinically life-threatening bleeding (e.g. central nervous system bleeding, menorrhagia with significant drop in hemoglobin).
- Participant has a history of coagulopathy disorders other than ITP.
- Participant has a history of arterial or venous thromboembolism (e.g. stroke, transient ischemic attach, myocardial infarction, deep vein thrombosis or pulmonary embolism) within the 6 months prior to randomization or requires anticoagulant treatment.
- Participant has 12-lead ECG with changes considered to be clinically significant upon medical review at baseline.
- Participant has severe renal impairment (glomerular filtration rate less than 45ml/min/1.73 m2).
- Participant has 3 × upper limit of normal of any of the following: alanine aminotransferase, aspartate aminotransferase, or alkaline phosphatase.
- Participant with any of the following conditions: severe immunodeficiency, active or previous malignancy, human immunodeficiency virus (HIV), hepatitis B or C virus infection, pregnancy or lactation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Yu Hou, Pro. contact
About this study
Official title: Dicycle Versus Tri-cycle High-dose Dexamethasone in Adult ITP: a Multicenter Randomized Controlled Trial
Primary immune thrombocytopenia is an autoimmune disorder characterised by decreased platelet counts and increased bleeding risk. Corticosteroids have been the standard initial treatment of primary immune thrombocytopenia for more than 30 years. The aim of this randomized controlled trial is to compare the efficacy and safety of high-dose dexamethasone in treating new-diagnosed primary immune thrombocytopenia (ITP) in di-cycle and tri-cycle.
Read the detailed description
In this multicentre, open-label, randomized controlled trial, about 118 new-diagnosed ITP patients will be enrolled from five tertiary medical centres in China. Eligible participants are randomly assigned (1:1) to 2 groups: group DEX2 and group DEX3. In group DEX2, dexamethasone was administered orally at 40 mg per day for two cycles (days1-4, and days 11-14). In group DEX3, dexamethasone was administered orally at 40 mg per day for three cycles (days1-4, days 11-14, and days 21-24). The clinical effect, onset time, duration of efficacy and adverse reactions were observed to compare the efficacy and safety of two different plans.
- Conditions
- Thrombocytopenia
- Being tested
- Dexamethasone
- Keywords
- ITP, Dexamethasone
- Medical subject headings
- Thrombocytopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
Also called DEX
given orally at 40 mg per day for two cycles (days1-4, and days 11-14).
DexamethasoneDrug
Also called DEX
given orally at 40 mg per day for three cycles (days1-4, days 11-14, and days 21-24).
| Study group | Role | What they receive |
|---|---|---|
| group DEX2 | Experimental | In group DEX2, dexamethasone was administered orally at 40 mg per day for two cycles (days1-4, and days 11-14). Receives: Drug: Dexamethasone |
| group DEX3 | Experimental | In group DEX3, dexamethasone was administered orally at 40 mg per day for three cycles (days1-4, days 11-14, and days 21-24). Receives: Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sustained response
Sustained response was defined as platelet count maintained above 30 × 10^9/L with an absence of bleeding symptoms or no requirement for additional ITP treatment for six consecutive months following achievement of initial response. Complete response was defined as a platelet count of 100 × 10^9 cells per L or higher and an absence of bleeding. Partial response was defined as a platelet count of 30×10^9 cells per L or higher, but less than 100×10^9 cells per L, and at least a doubling of the baseline platelet count and an absence of bleeding.
Measured: Month 6
Secondary outcomes (6)
Initial response
Initial responses were assessed by day 24. Complete response was defined as a platelet count of 100 × 10^9 cells per L or higher and an absence of bleeding. Partial response was defined as a platelet count of 30×10^9 cells per L or higher, but less than 100×10^9 cells per L, and at least a doubling of the baseline platelet count and an absence of bleeding.
Measured: Day 24
Time to response
Time to response was defined as the time from treatment initiation to achieve a complete response or a partial response, whichever came first, assessed up to day 24.
Measured: 24 days
Duration of response
Duration of response was defined as the time from achievement of a complete response or a partial response to the loss of response (platelet count <30 × 10^9 cells per L; measured on two occasions more than 1 day apart or the presence of bleeding).
Measured: 12 months
Bleeding scores
Bleeding symptoms were graded according a standardized bleeding scale specific to primary immune thrombocytopenia on the basis of site and severity of bleeding by Khellaf et al (PMID: 15951296). A modification was made to exclude age from the original scale so that only bleeding symptoms were described. At each visit, we recorded bleeding scores.Scores ranged from 0 to 59, with higher values indicating higher bleeding risk.
Measured: 12 months
Health-related quality of life assessment
Health-related quality of life was assessed using a self-administered immune thrombocytopenia Patient Assessment Questionnaire (ITP-PAQ) at baseline and at week 12. Scores ranged from 0 to 100, with higher values indicating better quality of life.
Measured: 12 weeks
The number of participants with Adverse events
Adverse events were graded according to the Common Terminology Criteria for Adverse Events (version 4.0). At each visit, we recorded adverse events.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2025
- Study start1 May 2025 (estimated)
- Primary completion30 May 2026 (estimated)
- Study completion30 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 118 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ming Hou, Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06913374
- Sponsor's protocol ID
- DEX 2v3 in ITP
- Status last verified
- Apr 2025
- First submitted
- 30 Mar 2025
- Last updated
- 8 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dicycle Versus Tri-cycle High-dose Dexamethasone in Adult ITP: a Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06913374
- Acronym / sponsor ID
- DEX 2v3 in ITP
- Conditions
- Thrombocytopenia
- Keywords
- ITP, Dexamethasone
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 118 participants (estimated)
- Lead sponsor
- Shandong UniversityUniversity, hospital or other
- Study start
- 1 May 2025 (estimated)
- Primary completion
- 30 May 2026 (estimated)
- Study completion
- 30 May 2027 (estimated)
- First posted
- 6 Apr 2025 (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.
Primary immune thrombocytopenia is an autoimmune disorder characterised by decreased platelet counts and increased bleeding risk. Corticosteroids have been the standard initial treatment of primary immune thrombocytopenia for more than 30 years. The aim of this randomized controlled trial is to compare the efficacy and safety of high-dose dexamethasone in treating new-diagnosed primary immune thrombocytopenia (ITP) in di-cycle and tri-cycle.
Detailed description
In this multicentre, open-label, randomized controlled trial, about 118 new-diagnosed ITP patients will be enrolled from five tertiary medical centres in China. Eligible participants are randomly assigned (1:1) to 2 groups: group DEX2 and group DEX3. In group DEX2, dexamethasone was administered orally at 40 mg per day for two cycles (days1-4, and days 11-14). In group DEX3, dexamethasone was administered orally at 40 mg per day for three cycles (days1-4, days 11-14, and days 21-24). The clinical effect, onset time, duration of efficacy and adverse reactions were observed to compare the efficacy and safety of two different plans.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group DEX2 | Experimental | Drug: DexamethasoneIn group DEX2, dexamethasone was administered orally at 40 mg per day for two cycles (days1-4, and days 11-14). |
| group DEX3 | Experimental | Drug: DexamethasoneIn group DEX3, dexamethasone was administered orally at 40 mg per day for three cycles (days1-4, days 11-14, and days 21-24). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participant must be at least 18 years of age at the time of the screening.
- Participant may be male or female.
- Participant has a confirmed diagnosis of newly diagnosed ITP according to the 2019 International Working Group assessment at screening, and has a baseline platelet count of less than 30 × 10^9 cells per L or had bleeding manifestations, or both.
Key exclusion criteria (8 listed)
- Participant has evidence of a secondary cause of immune thrombocytopenia (e.g. leukemia, lymphoma, common variable immune- deficiency, systemic lupus erythematosus, autoimmune thyroid disease, past medical history of untreated H. pylori infection) or to drug treatments (e.g. heparin, quinine, antimicrobials, anticonvulsants) or participant has a multiple immune cytopenia, e.g. Evan's syndrome.
- Participant has clinically life-threatening bleeding (e.g. central nervous system bleeding, menorrhagia with significant drop in hemoglobin).
- Participant has a history of coagulopathy disorders other than ITP.
- Participant has a history of arterial or venous thromboembolism (e.g. stroke, transient ischemic attach, myocardial infarction, deep vein thrombosis or pulmonary embolism) within the 6 months prior to randomization or requires anticoagulant treatment.
- Participant has 12-lead ECG with changes considered to be clinically significant upon medical review at baseline.
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 |
|---|---|---|
| DexamethasoneAlso: DEXgiven orally at 40 mg per day for two cycles (days1-4, and days 11-14). | Drug | group DEX2 |
| DexamethasoneAlso: DEXgiven orally at 40 mg per day for three cycles (days1-4, days 11-14, and days 21-24). | Drug | group DEX3 |
Primary outcome
Sustained response
Time frame: Month 6
Sustained response was defined as platelet count maintained above 30 × 10^9/L with an absence of bleeding symptoms or no requirement for additional ITP treatment for six consecutive months following achievement of initial response. Complete response was defined as a platelet count of 100 × 10^9 cells per L or higher and an absence of bleeding. Partial response was defined as a platelet count of 30×10^9 cells per L or higher, but less than 100×10^9 cells per L, and at least a doubling of the baseline platelet count and an absence of bleeding.
6 secondary outcomes
Initial response
Time frame: Day 24
Time to response
Time frame: 24 days
Duration of response
Time frame: 12 months
Bleeding scores
Time frame: 12 months
Health-related quality of life assessment
Time frame: 12 weeks
The number of participants with Adverse events
Time frame: 12 months
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 8 Apr 2025.
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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.
Yu Hou, Pro. contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Dexamethasone in people with Thrombocytopenia, run by Shandong University at 1 site 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 3 inclusion and 8 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: opening soon, as of the sponsor's last update on 8 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Contact Ming Hou, Pro. (86-531-82169896, houming@medmail.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sustained response (time frame: Month 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Apr 2025.