- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05411874
A Multicenter Randomized Open-label Study of Chidamide Plus HD-DEX Versus HD-DEX in ITP
June 6, 2022 updated by: Ming Hou, Shandong University
A Multicenter Randomized Open-label Study of Chidamide Combined With High-dose Dexamethasone Versus High-dose Dexamethasone in the Management of Newly-Diagnosed Immune Thrombocytopenia
Recently, histone deacetylase inhibitors (HDACi) has been used for their anti-inflammatory and immunomodulatory activities.
It has been shown that HDACi can alleviate graft-versus-host disease by enhancing the number and function of Foxp3+ Tregs.
Our group found that low-dose HDACi alleviated thrombocytopenia in both passive and active murine models of ITP.
Furthermore, low-dose HDACi attenuated macrophage phagocytosis of antibody-coated platelets, stimulated production of natural Foxp3+ Tregs, promoted peripheral conversion of T cells into Tregs, and restored Treg suppressive function in vivo and in vitro.
The project was undertaking by Qilu Hospital of Shandong University and other 10 well-known hospitals in China.
In order to report the efficacy and safety of the low dose chidamide combined with high-dose dexamethasone versus high-dose dexamethasone in the management of ITP.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
Primary immune thrombocytopenia (ITP) is an autoimmune bleeding disorder with low platelet count.
Low-dose HDACi alleviated thrombocytopenia in both passive and active murine models of ITP.
In this multicentre, open-label, randomized controlled trial, newly diagnosed ITP patients will be enrolled from 11 tertiary medical centres in China.
Participants will be randomly assigned into the combination group or the monotherapy group by masked statisticians in a 1:1 ratio.
The primary endpoints are sustained response at month 6.
The secondary outcomes include initial response, time to response, duration of response, bleeding score, health-related quality of life assessment, and safety issue.
This study will compare the efficacy and safety of low dose chidamide combined with high-dose dexamethasone versus high-dose dexamethasone monotherapy in adults with primary immune thrombocytopenia.
Study Type
Interventional
Enrollment (Anticipated)
100
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Ming Hou, Doctor
- Email: houming@medmail.com.cn
Study Contact Backup
- Name: Ming Hou, Doctor
- Phone Number: 82169896
- Email: houming@medmail.com.cn
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- newly diagnosed ITP patients need of treatment(s) to minimize the risk of clinically significant bleeding primary ITP confirmed by excluding other supervened causes of thrombocytopenia
Exclusion Criteria:
- pregnancy hypertension cardiovascular disease diabetes liver and kidney function impairment HCV, HIV, HBsAg seropositive status patients with systemic lupus erythematosus and/or antiphospholipid syndrome
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Chidamide plus HD-DXM
Chidamide (orally at 5 mg biw for 24 weeks) HD-DXM (orally at 40 mg daily for 4 days) |
5mg po biw for 24 weeks
40mg po qd for 4days
|
ACTIVE_COMPARATOR: HD-DXM
HD-DXM (orally at 40 mg daily for 4 days )
|
40mg po qd for 4days
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sustained response
Time Frame: 6 month
|
The maintenance of platelet count ≥ 30 x 10^9/L, at least 2-fold increase of the baseline count, the absence of bleeding, and no need for rescue medication at the 6-month follow-up.
|
6 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Initial response
Time Frame: day 14
|
CR: platelet count ≥ 100 × 109/L and absence of bleeding; R: platelet count ≥ 30 × 109/L but < 100 × 109/L and a doubling from baseline and absence of bleeding.
|
day 14
|
Number of patients with bleeding
Time Frame: 6 month
|
Number of patients with bleeding complication.
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.
Scores ranged from 0 to 59, with higher values indicating higher bleeding risk.
|
6 month
|
Number of patients with adverse events
Time Frame: 6 month
|
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.
|
6 month
|
Time to response
Time Frame: 6 month
|
The time from starting treatment to time of achievement of CR or R
|
6 month
|
Duration of response (DOR)
Time Frame: 6 month
|
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).
|
6 month
|
Health-related quality of life assessment
Time Frame: 6 month
|
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.
|
6 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Provan D, Stasi R, Newland AC, Blanchette VS, Bolton-Maggs P, Bussel JB, Chong BH, Cines DB, Gernsheimer TB, Godeau B, Grainger J, Greer I, Hunt BJ, Imbach PA, Lyons G, McMillan R, Rodeghiero F, Sanz MA, Tarantino M, Watson S, Young J, Kuter DJ. International consensus report on the investigation and management of primary immune thrombocytopenia. Blood. 2010 Jan 14;115(2):168-86. doi: 10.1182/blood-2009-06-225565. Epub 2009 Oct 21.
- Rodeghiero F, Stasi R, Gernsheimer T, Michel M, Provan D, Arnold DM, Bussel JB, Cines DB, Chong BH, Cooper N, Godeau B, Lechner K, Mazzucconi MG, McMillan R, Sanz MA, Imbach P, Blanchette V, Kuhne T, Ruggeri M, George JN. Standardization of terminology, definitions and outcome criteria in immune thrombocytopenic purpura of adults and children: report from an international working group. Blood. 2009 Mar 12;113(11):2386-93. doi: 10.1182/blood-2008-07-162503. Epub 2008 Nov 12.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ANTICIPATED)
October 1, 2022
Primary Completion (ANTICIPATED)
October 30, 2023
Study Completion (ANTICIPATED)
October 30, 2024
Study Registration Dates
First Submitted
June 6, 2022
First Submitted That Met QC Criteria
June 6, 2022
First Posted (ACTUAL)
June 9, 2022
Study Record Updates
Last Update Posted (ACTUAL)
June 9, 2022
Last Update Submitted That Met QC Criteria
June 6, 2022
Last Verified
June 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ITP-Chidamide plus DEX
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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