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High-Dose Dexamethasone Combined With Orelabrutinib Versus High-Dose Dexamethasone Combined With Placebo in Adult Patients With Newly Diagnosed Primary Immune Thrombocytopenia

ConditionPrimary Immune Thrombocytopenia (ITP)
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-80
SponsorShandong University

About this trial

This is a randomized controlled study of high-dose Dexamethasone combined with Orelabrutinib versus high-dose Dexamethasone combined with placebo in adult patients with newly diagnosed Primary Immune Thrombocytopenia.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Subjects must thoroughly understand the nature, significance, potential benefits, possible inconveniences, and potential risks of the trial prior to enrollment. They must understand the study procedures and voluntarily sign the informed consent form.

Male or female subjects aged 18-80 years (inclusive).

Body weight ≥35 kg at screening.

Adult patients with newly diagnosed, untreated primary ITP, with platelet count (PLT) <30×10⁹/L and no active bleeding in vital organs.

Disqualifiers

Subjects with severe ITP at screening (e.g., life-threatening thrombocytopenia, major bleeding events, or requiring urgent treatment including intravenous immunoglobulin, high-dose glucocorticoids, or plasma exchange), whom the investigator anticipates will require rescue treatment within 2 weeks after enrollment.

Subjects with autoimmune systemic diseases other than ITP, unless the investigator determines that such conditions will not affect the evaluation of study outcomes.

Subjects who failed to respond to prior treatment with oral dexamethasone 40 mg/day for 4 days, defined as meeting any of the following criteria on any day between Day 5 and Day 7 post-treatment: ① PLT <30×10⁹/L; ② <2-fold increase from baseline; or ③ active bleeding.

History of intracranial hemorrhage within 6 months prior to screening.

Trial design

Design model

Parallel

Treatments tested in this trial

  • High-Dose Dexamethasone Combined with Orelabrutinib

    Drug

    Orelabrutinib 50 mg once daily (QD) (for 3 consecutive months) combined with Dexamethasone 40 mg/day for 4 days

  • High-Dose Dexamethasone Combined with Placebo

    Drug

    Placebo 50 mg once daily (QD) (for 3 consecutive months) combined with Dexamethasone 40 mg/day for 4 days

Treatment groups

86 Participants
are divided into 2 treatment groups
Group A: Control GroupActive comparator 1 intervention
Group B: Experimental GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Overall Response Rate (ORR)

Time frame
Throughout the study period, an average of 6 months

Secondary outcomes

1

Overall Response Rate (ORR)

Time frame
Throughout the study period, an average of 1/2/3 months

Other outcomes

1

Occurrence of adverse events and serious adverse events according to CTCAE V5.0

Time frame
Up to 2 years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shandong University

Lead sponsor

Qilu Hospital of Shandong University

Sponsor institution

Source ClinicalTrials.gov
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