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The Study of Different Cycles of High-dose Dexamethasone in the Treatment of ITP

ConditionThrombocytopenia
Trial statusNot yet recruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorShandong University

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Dexamethasone

    Drug

    given orally at 40 mg per day for two cycles (days1-4, and days 11-14).

  • Dexamethasone

    Drug

    given orally at 40 mg per day for three cycles (days1-4, days 11-14, and days 21-24).

Treatment groups

118 Participants
are divided into 2 treatment groups
Group A: group DEX2Experimental treatment 1 intervention
Group B: group DEX3Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Month 6

Secondary outcomes

1

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.

Time frame
Day 24
2

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.

Time frame
24 days
3

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).

Time frame
12 months
4

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.

Time frame
12 months

Other outcomes

Sponsors and contacts

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

Shandong University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: