Ignite Creation Date:
2024-07-17 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06479317
Status:
RECRUITING
Last Update Posted:
2024-06-28
First Post:
2024-06-22
Brief Title:
The Efficacy and Safety of HCQ Plus DEX in ANA Positive ITP
Sponsor:
Yunfeng Cheng
Organization:
Shanghai Zhongshan Hospital
Study Overview
Official Title:
The Efficacy and Safety of Hydroxychloroquine Plus Dexamethasone in Antinuclear Antibody-positive Patients With Primary Immune Thrombocytopenia-- The Multicenter Randomized Open-labled Clinical Trial
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to learn if hydroxychloroquine HCQ plus dexamethasone DEX works to treat primary immune thrombocytopenia with positive anti-nuclear antibodies in adults It will also learn about the safety of HCQ plus DEX The main questions it aims to answer are
Does HCQ plus DEX raise the response rate in participants compared to DEX alone Does HCQ plus DEX prolong the response duration in participants compared to DEX alone What medical problems do participants have when taking HCQ plus DEX Researchers will compare HCQ plus DEX with DEX alone to see if HCQ plus DEX works better to treat primary immune thrombocytopenia with positive anti-nuclear antibodies
Participants will
Take DEX every day for consecutive 4 days if platelet count does not recover higher than 30109L after 2 weeks take DEX every day for another consecutive 4 days with or without HCQ twice a day for 1 year Visit the clinic once every 1 weeks for the first 4 weeks and once every 2-4 weeks in the following 11 months for checkups and tests Keep a diary of their symptoms
Does HCQ plus DEX raise the response rate in participants compared to DEX alone Does HCQ plus DEX prolong the response duration in participants compared to DEX alone What medical problems do participants have when taking HCQ plus DEX Researchers will compare HCQ plus DEX with DEX alone to see if HCQ plus DEX works better to treat primary immune thrombocytopenia with positive anti-nuclear antibodies
Participants will
Take DEX every day for consecutive 4 days if platelet count does not recover higher than 30109L after 2 weeks take DEX every day for another consecutive 4 days with or without HCQ twice a day for 1 year Visit the clinic once every 1 weeks for the first 4 weeks and once every 2-4 weeks in the following 11 months for checkups and tests Keep a diary of their symptoms
Detailed Description:
Primary immune thrombocytopenia Primary immune thrombocytopenia ITP is an acquired autoimmune hemorrhagic disease characterized with decreased peripheral platelet count and increased risk of bleeding It has been reported that 333 -392 of ITP patients have positive antinuclear antibodies ANA in the course of diseaseIn the meantime they do not meet the diagnostic criteria for rheumatic diseases such as lupus erythematosusSLE ITP patients with positive ANA are prone to relapse and chronicity Therefore it is necessary to explore new clinical treatments to attain longer-term remission in these patients
Hydroxychloroquine HCQ has immune modulating role on a variety of immune cellsA clinical trial enrolled immune thrombocytopenia secondary to SLE and ITP with positive anti-nuclear antibodiy ANA were treated with HCQ combined with glucocorticoids The results showed an overall response rate of 60 24 40 including 18 continuous complete response CR and 6 continuous response R and some patients had continued elevated platelet counts 3 months after treatment initiation The above studies illustrate that HCQ contributes to the treatment of chronic ITP especially as a long-term therapeutic agent with low economic burden and well-tolerated In conclusion it can be seen that HCQ and dexamethasone have complementary mechanism of action and complementary time window which can be used as a combination for the treatment of ITP select
Hydroxychloroquine HCQ has immune modulating role on a variety of immune cellsA clinical trial enrolled immune thrombocytopenia secondary to SLE and ITP with positive anti-nuclear antibodiy ANA were treated with HCQ combined with glucocorticoids The results showed an overall response rate of 60 24 40 including 18 continuous complete response CR and 6 continuous response R and some patients had continued elevated platelet counts 3 months after treatment initiation The above studies illustrate that HCQ contributes to the treatment of chronic ITP especially as a long-term therapeutic agent with low economic burden and well-tolerated In conclusion it can be seen that HCQ and dexamethasone have complementary mechanism of action and complementary time window which can be used as a combination for the treatment of ITP select
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None