Eltrombopag Plus Diacerein vs Eltrombopag in Adult ITP
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|ClinicalTrials.gov Identifier: NCT04917679|
Recruitment Status : Unknown
Verified December 2020 by Qilu Hospital of Shandong University.
Recruitment status was: Recruiting
First Posted : June 8, 2021
Last Update Posted : June 8, 2021
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|Condition or disease||Intervention/treatment||Phase|
|Thrombocytopenia||Drug: Eltrombopag plus diacerein Drug: Eltrombopag||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Eltrombopag Plus Diacerein vs Eltrombopag in Adult Primary Immune Thrombocytopenia: a Multicenter Randomized Controlled Trial|
|Actual Study Start Date :||September 1, 2020|
|Estimated Primary Completion Date :||December 1, 2021|
|Estimated Study Completion Date :||December 1, 2022|
Experimental: Combination group
Eltrombopag plus diacerein
Drug: Eltrombopag plus diacerein
In the combination group, eltrombopag will be administered orally at an initial dose of 75mg daily for 14 days, and diacerein will be given orally at an initial dose of 50mg bid concomitantly for 14 days (D1-D14). During treatment period, treating physicians will modify the dosage of trial treatment to maintain participants' platelet count at the range of 50 - 150 × 10^9/L as follows: (1) if platelet count is less than 150 × 10^9/L, continue the original treatment (eltrombopag 75mg daily plus diacerein 50mg bid); (2) if platelet count is between 150 × 10^9/L to 250 × 10^9/L, the treatment will be modified to eltrombopag 50mg daily plus diacerein 50mg bid; (3) if platelet count is over 250 × 10^9/L, original treatment (both eltrombopag and diacerein) need to be stopped, and platelet count should be reexamined every other day, and the treatment (eltrombopag 50mg daily plus diacerein 50mg bid ) will be restarted until platelet count is below 100 × 10^9/L.
Placebo Comparator: Monotherapy group
In the monotherapy group, eltrombopag also will be administered orally at an initial dose of 75mg daily for 14 days (D1-D14), and the individualized dosage could be modified by treating physicians to maintain participants' platelet count between 50 × 10^9/L to 150 × 10^9/L.
- Initial response at Day 15 [ Time Frame: Day 15 ]The primary outcomes of this trial are initial responses at Day 15 without any additional ITP-specific intervention. Complete response was defined as a platelet count at or above 100 × 10⁹ cells per L and an absence of bleeding. Partial response was defined as a platelet count at or above 30 × 10⁹ cells per L but less than 100 × 10⁹ cells per L and at least a doubling of the baseline platelet count and an absence of bleeding. No response was defined as a platelet count of less than 30 × 10⁹ cells per L, or less than two-times increase from baseline platelet count, or bleeding.
- Response at Day 28 [ Time Frame: Day 28 ]Responses were assessed at day 28. Complete response was defined as a platelet count at or above 100 × 10⁹ cells per L and an absence of bleeding. Partial response was defined as a platelet count at or above 30 × 10⁹ cells per L but less than 100 × 10⁹ cells per L and at least a doubling of the baseline platelet count and an absence of bleeding. No response was defined as a platelet count of less than 30 × 10⁹ cells per L, or less than two-times increase from baseline platelet count, or bleeding.
- Time to response [ Time Frame: 28 days ]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 28.
- Duration of response [ Time Frame: 12 months ]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 × 10⁹ cells per L; measured on two occasions more than 1 day apart or the presence of bleeding).
- Bleeding scores [ Time Frame: 12 months ]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. Routine visits were scheduled once a week for the first 4 weeks and once a month thereafter. Scores ranged from 0 to 59, with higher values indicating higher bleeding risk.
- Health-related quality of life assessment [ Time Frame: 12 weeks ]Health-related quality of life was assessed using a self-administered immune thrombocytopenia Patient Assessment Questionnaire (ITP-PAQ) at baseline and at week 12. Scores ranged from 0 to 100, with higher values indicating better quality of life.
- The number of participants with Adverse events [ Time Frame: 12 months ]Adverse events were graded according to the Common Terminology Criteria for Adverse Events (version 4.0). At each visit, we recorded adverse events. Routine visits were scheduled once a week for the first 4 weeks and once a month thereafter.
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04917679
|Contact: Yu Houemail@example.com|
|Qilu hospital, Shandong University||Recruiting|
|Jinan, Shandong, China|
|Contact: Yu Hou|
|Principal Investigator:||Yu Hou||Qilu Hospital, Shandong University|
|Responsible Party:||Qilu Hospital of Shandong University|
|Other Study ID Numbers:||
|First Posted:||June 8, 2021 Key Record Dates|
|Last Update Posted:||June 8, 2021|
|Last Verified:||December 2020|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Blood Platelet Disorders