Eltrombopag Plus Diacerein vs Eltrombopag in Adult ITP

  • STATUS
    Recruiting
  • End date
    Dec 1, 2022
  • participants needed
    100
  • sponsor
    Qilu Hospital of Shandong University
Updated on 19 June 2021
platelet count
eltrombopag

Summary

Primary immune thrombocytopenia (ITP) is an autoimmune bleeding disorder with low platelet count. As the first choice of the second-line treatment of ITP, thrombopoietin receptor agonist (TPO-RA) enable long-term remission in 50% to 60% of cases. However, about half of patients have no response or loss of response due to unknown reasons, which can't be effectively improved by increasing the drug dose. Diacerein is a slow-acting medicine of the class anthraquinone used to treat joint diseases such as osteoarthritis. We speculate that the addition of diacerein to eltrombopag may offer sensitizer effect and maximize efficacy, and serve as an optimized second-line treatment for ITP patients.

Description

In this multicentre, open-label, randomized controlled trial, 100 eltrombopag-inefficient or relapsed ITP patients will be enrolled from five tertiary medical centres in China. Participants will be randomly assigned into the combination group (eltrombopag orally at initial dose of 75 mg daily for 14 days, plus diacerein orally at initial dose of 50 mg bid for 14 days) or the monotherapy group (eltrombopag orally at initial dose of 75 mg daily for 14 days) by masked statisticians in a 1:1 ratio. The primary endpoints are initial response at D15 without any additional ITP-specific intervention. The secondary outcomes include response at D28, time to response, duration of response, bleeding score, health-related quality of life assessment, and safety issue. Full analysis set, including all participants who receive allocated intervention and have a valid baseline data, and at least 1 valid post-baseline platelet count measurement, will be used to assess efficacy.This study will compare the efficacy and safety of eltrombopag-diacerein with eltrombopag monotherapy in adults with primary immune thrombocytopenia. The results of this study will provide evidence for the sensitizer effect of diacerein to eltrombopag, and offer an optimized second-line treatment for ITP patients.

Details
Condition Thrombocytopenia and Thrombocytopenia Prevention, Thrombocytopenia
Treatment Eltrombopag, Eltrombopag plus diacerein
Clinical Study IdentifierNCT04917679
SponsorQilu Hospital of Shandong University
Last Modified on19 June 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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 ITP according to the 2019 International Working Group assessment at screening
Participant who didn't respond to eltrombopag retreatment (75mg by mouth once a day for 14 days) after eltrombopag previous treatment inefficient or relapsed (platelet count below 30 10^9/L or below 2-fold increase from baseline platelet count, or bleeding)
Bone marrow biopsy is performed in participants over 60 years to exclude hematological malignancies

Exclusion Criteria

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 has received corticosteroids, rh-TPO, romiplostim, or immunosuppression within 4 weeks before screening
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
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