A Phase 4 interventional study of standard-dose methylprednisolone/prednisone. and thrombopoietin receptor agonist(TPO-RA), including but not limited to hetrombopag or eltrombopag. in ITP - Immune Thrombocytopenia, sponsored by Institute of Hematology & Blood Diseases Hospital, China. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-08-26.
Sponsored by Institute of Hematology & Blood Diseases Hospital, China · Phase 4, Interventional, and Treatment
Among 33 studies in Purpura, Thrombocytopenic, Idiopathic by Institute of Hematology & Blood Diseases Hospital, China — 27 open to participants now, 29 under way, 2 of them phase 3. Purpura, Thrombocytopenic, Idiopathic · Institute of Hematology & Blood Diseases Hospital, China.
Among the 33 studies in Purpura, Thrombocytopenic, Idiopathic by Institute of Hematology & Blood Diseases Hospital, China, this one is the 22nd largest by planned enrollment of the 31 interventional ones that give a count, is one of 8 that started in 2026, is one of 4 in phase 4, reaches primary completion later than 20 of the 28 other live ones, and was the 33rd registered.
504 studies on the registry are indexed under Purpura, Thrombocytopenic, Idiopathic; 159 are open to participants now.
Browse Purpura, Thrombocytopenic, Idiopathic studies →27 of the 33 studies in Purpura, Thrombocytopenic, Idiopathic by Institute of Hematology & Blood Diseases Hospital, China are open now, in 1 country. Recruiting first, the newest first:
Institute of Hematology & Blood Diseases Hospital, China · Sites in China
Ages 18+
Institute of Hematology & Blood Diseases Hospital, China · Sites in China
Ages 6–18
Institute of Hematology & Blood Diseases Hospital, China · Sites in China
Ages 18+
Institute of Hematology & Blood Diseases Hospital, China · Sites in China
Ages 18+
Institute of Hematology & Blood Diseases Hospital, China · Sites in China
Ages 60+
By country, each count listing its studies:
Of the 103 Purpura, Thrombocytopenic, Idiopathic studies recruiting now, 49 (48%) set no upper age limit and 42 (41%) stop at 75 or younger; 27 take children under 18; 4 take healthy volunteers.
This study: 18 Years to 75 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
33 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 1 · Phase 2 23 · Phase 3 2 · Phase 4 4
First in 2012; this study’s year is marked. 8 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 38 is below the median of 58 across 377 interventional studies indexed under Purpura, Thrombocytopenic, Idiopathic.
Median enrollment 60 across the 31 interventional studies, 500 across the 2 observational. Of the 4 that completed or were terminated, 0 (0%) have results posted.
This tab as a report to print or save as PDF → With an account.
Institute of Hematology & Blood Diseases Hospital, China is the lead sponsor of 412 studies on the registry; 291 are open to participants now.
5 of the studies in Purpura, Thrombocytopenic, Idiopathic by Institute of Hematology & Blood Diseases Hospital, China that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06107582Institute of Hematology & Blood Diseases Hospital, ChinaLongitudinal Cohort of Pediatric Primary Immune Thrombocytopenia (ITP) | 2026-12 |
| NCT07362199Institute of Hematology & Blood Diseases Hospital, ChinaAnti-CD38 Monoclonal Antibody Combined With Rituximab in the Management of Primary Immune Thrombocytopenia (ITP) | 2027-03 |
| NCT07212322Institute of Hematology & Blood Diseases Hospital, ChinaA Study of CD19 UCAR-T Cells in Subjects With Autoimmune Diseases | 2027-05-20 |
| NCT07788456Institute of Hematology & Blood Diseases Hospital, ChinaMulti-target Drugs Sequential Combination Therapy in Adults Patients With Newly Diagnosed Primary Immune Thrombocytopenia | 2027-05-30 |
| NCT07297563Institute of Hematology & Blood Diseases Hospital, ChinaAnti-CD38 Monoclonal Antibody Versus Rituximab in the Management of Primary Immune Thrombocytopenia (ITP) | 2027-11 |
Add all 5 to your calendar (.ics) → With an account.
Among the 33 studies in Purpura, Thrombocytopenic, Idiopathic by Institute of Hematology & Blood Diseases Hospital, China, from their registry updates:
Nothing recorded among them since 2026-09-25.
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This prospective, single-arm, multicenter, exploratory study will enroll 38 adults patients with newly diagnosed primary immune thrombocytopenia (ITP). Patients will receive standard-dose corticosteroids plus a thrombopoietin receptor agonist (TPO-RA) as initial therapy During the core treatment phase (Weeks 1-12). Corticosteroids will be tapered and discontinued within 8 weeks, whereas TPO-RA treatment will continue for 12 weeks. For patients with treatment failure( defined as platelet count \< 30 × 10\^9/L or less than 2-fold increase of baseline platelet count or bleeding) ,a sequential multitarget combination strategy will be explored in subsequent treatment phases. Specifically, patients with treatment failure after 2 weeks of initial therapy (Weeks 3-12), will receive the ongoing TPO-RA in combination with either rituximab or an anti-CD38 monoclonal antibody（mAb） as sequential combination therapy.
During the core treatment follow-up phase (24 weeks), patients with treatment failure will enter the exploratory treatment phase (Weeks 13-36) .
Patients who received multi-target drug therapy during the core treatment period will switch to an alternative TPO-RA with cross-administered rituximab and anti-CD38 mAb, while those who did not will receive sequential rituximab or anti-CD38 mAb.
Finally, patients will enter the safety follow up period (4 weeks, weeks 37-40).
The study will be conducted in three phases.
Phase 1. Core treatment phase includes initial treatment and sequential combination therapy (12 weeks, weeks 1-12):
Patients will receive standard-dose methylprednisolone or prednisone in combination with a thrombopoietin receptor agonist (TPO-RA) as initial therapy.Corticosteroids will be tapered and discontinued within 8 weeks; tapering will begin immediately in patients who achieve complete response (CR) and will also be initiated after 4 weeks in patients who do not achieve response (R). TPO-RA therapy will continue for 12 weeks, with dose adjustments made according to the approved prescribing information. Patients with treatment failure( defined as platelet count \< 30 × 10\^9/L or less than 2-fold increase of baseline platelet count or bleeding) after 2 weeks of initial therapy (Weeks 3-12) will receive the ongoing TPO-RA in combination with either rituximab or an anti-CD38 monoclonal antibody as sequential combination therapy.
Phase 2. Core-treatment follow-up and exploratory treatment phase (24weeks, weeks 13-36):
During the core treatment follow-up phase, patients with treatment failure will enter the exploratory treatment phase. Patients who did not receive rituximab or anti-CD38 monoclonal antibody during the core treatment phase will receive a switched TPO-RA combined with either rituximab or anti-CD38 monoclonal antibody, whereas patients who received either rituximab or anti-CD38 monoclonal antibody during the core phase will receive a switched TPO-RA combined with cross-administered rituximab and anti-CD38 monoclonal antibody.TPO-RA therapy will also continue for 12 weeks.
Phase3. Safety follow-up phase (4weeks,weeks 37-40).
Rescue therapy includes, but is not limited to, intravenous immunoglobulin (IVIG), platelet transfusion, and vindesine. A switch to another thrombopoietin receptor agonist (TPO-RA) will be considered rescue therapy during the core treatment period. Administration of recombinant human thrombopoietin (rhTPO) will also be considered rescue therapy.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Any other medical history or condition that, in the investigator's judgment, makes the participant unsuitable for the study.
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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
standard-dose corticosteroids plus a thrombopoietin receptor agonist (TPO-RA)
Drug: standard-dose methylprednisolone/prednisone. · Drug: thrombopoietin receptor agonist(TPO-RA), including but not limited to hetrombopag or eltrombopag.
the ongoing TPO-RA in combination with either rituximab or an anti-CD38 monoclonal antibody（mAb）
Drug: thrombopoietin receptor agonist(TPO-RA), including but not limited to hetrombopag or eltrombopag. · Drug: rituximab. · Drug: Daratumumab
a switched TPO-RA combined with either rituximab or anti-CD38 monoclonal antibody
Drug: thrombopoietin receptor agonist(TPO-RA), including but not limited to hetrombopag or eltrombopag. · Drug: rituximab. · Drug: Daratumumab
Methylprednisolone 0.8-1mg/kg/day administered intravenously or orally; or prednisone 1 mg/kg/day, up to a maximum dose of 80 mg/day
Dosing will follow the recommended dose in the prescribing information; in severe ITP, the initial dose will be selected according to BAT (best available therapy) principles.
Administered as 375 mg/m² by intravenous infusion for a single dose, or 100 mg by intravenous infusion once weekly for a total of 4 doses.
Administered at 16 mg/kg by intravenous infusion once weekly for a total of 4-8 doses.
sustained response rate
Defined as the proportion of patients who achieve a platelet count ≥30×10\^9/L at least 6 out of 12 scheduled visits during the 24 weeks following the core treatment period (weeks 13-36), in the absence of rescue therapy
Time frame: between weeks 13 and 36
time to response
The time from treatment initiation to achieve a complete response(platelet count ≥100 × 109/L and absence of bleeding) or a partial response(platelet count ≥30 × 10\^9/L and at least 2-fold increase of the baseline platelet count and absence of bleeding)
Time frame: in 0-12 weeks
Early response.
Proportion of patients achieving platelet count ≥30 × 10\^9/L and at least doubling baseline at 1 week after treatment initiation.
Time frame: at 1 week
Initial response
Proportion of patients achieving platelet count ≥30 × 10\^9/L and at least doubling baseline at 1 month after treatment initiation.
Time frame: at 1 month
overall response(OR) rate at week 12
Proportion of patients achieving complete response (CR) plus response (R) at Week 12
Time frame: at week 12
Proportion of patients requiring rescue therapy
Time frame: in 0-36 weeks
bleeding scores
Assessed according to the WHO Bleeding Scale and the ITP Bleeding Scale
Time frame: in 0-40 weeks
Immune Thrombocytopenia Patient Assessment Questionnaire (ITP-PAQ)
In all participants ,use ITP-PAQ to assess the HRQoL before and after treatment.
Time frame: in 0-40 weeks
Functional Assessment of 36-Item Short Form Survey (SF-36) scale
In all participants ,use SF-36 scale to assess the HRQoL before and after treatment.
Time frame: in 0-40 weeks
Plan to share: No — No plan to share IPD has been established at this time
Started Jun 2026 (actual). Primary completion is estimated for May 2027, 11 months after the start.
How these figures are worked out, and which studies are left out of them.
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Studies of the drug tested here: Daratumumab
Purpura, Thrombocytopenic, Idiopathic →
Institute of Hematology & Blood Diseases Hospital, China →