The Combination of Tacrolimus and High-dose Dexamethasone as First-line Treatment in Adult Immune Thrombocytopenia

  • End date
    Jul 1, 2023
  • participants needed
  • sponsor
    Peking University People's Hospital
Updated on 18 February 2021


Randomized, open-label, multicenter study to compare the efficacy and safety of Combination of High-dose Dexamethasone and Tacrolimus versus High-dose Dexamethasone for the first-line treatment of adults with primary immune thrombocytopenia (ITP).


The investigators are undertaking a parallel group, multicenter, randomized controlled trial of 100 adults with ITP in China. Patients were randomized to tacrolimuis plus high-dose dexamethasone and high-dose dexamethasone monotherapy group. Platelet count, bleeding and other symptoms were evaluated before and after treatment. Adverse events are also recorded throughout the study.

Condition IDIOPATHIC THROMBOCYTOPENIC PURPURA, Idiopathic Thrombocytopenic Purpura (ITP), Thrombocytopenic, Autoimmune disease, Autoimmune disease, Inosine Triphosphate, Immune (Idiopathic) Thrombocytopenic Purpura (ITP), Immune Thrombocytopenia, Immune (Idiopathic) Thrombocytopenic Purpura (ITP), Idiopathic Thrombocytopenic Purpura (ITP), Thrombocytopenic, autoimmune thrombocytopenia
Treatment Tacrolimus, Dexamethasone
Clinical Study IdentifierNCT04747080
SponsorPeking University People's Hospital
Last Modified on18 February 2021


Yes No Not Sure

Inclusion Criteria

Confirmed newly-diagnosed, treatment-naive ITP
Platelet counts <30109/L
Platelet counts < 50109/L and significant bleeding symptoms (WHO bleeding scale 2 or above)
Willing and able to sign written informed consent

Exclusion Criteria

Received chemotherapy or anticoagulants or other drugs affecting the platelet counts within 6 months before the screening visit
Received first-line and second-line ITP-specific treatments (eg, steriods, cyclophosphamide, 6-mercaptopurine, vincristine, vinblastine, etc)
Current HIV infection or hepatitis B virus or hepatitis C virus infections
Active infection
Severe medical condition (lung, hepatic or renal disorder) other than chronic ITP. Unstable or uncontrolled disease or condition related to or impacting cardiac function (e.g., unstable angina, congestive heart failure, uncontrolled hypertension or cardiac arrhythmia)
Female patients who are nursing or pregnant, who may be pregnant, or who contemplate pregnancy during the study period; a history of clinically significant adverse reactions to previous corticosteroid therapy
Have a known diagnosis of other autoimmune diseases, established in the medical history and laboratory findings with positive results for the determination of antinuclear antibodies, anti-cardiolipin antibodies, lupus anticoagulant or direct Coombs test
Patients who are deemed unsuitable for the study by the investigator
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