Ignite Creation Date:
2025-12-24 @ 7:50 PM
Ignite Modification Date:
2026-01-01 @ 4:11 PM
Study NCT ID:
NCT06479304
Status:
RECRUITING
Last Update Posted:
2024-06-28
First Post:
2024-06-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Efficacy and Safety of HCQ Plus Pred in ANA Positive ITP
Sponsor:
Yunfeng Cheng
Organization:
Study Overview
Official Title:
The Efficacy and Safety of Hydroxychloroquine Plus Prednisone in Antinuclear Antibody-positive Patients With Primary Immune Thrombocytopenia-- The Multicenter, Randomized, Open-lable 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 prednisone (Pred) works to treat primary immune thrombocytopenia with positive anti-nuclear antibodies in adults. It will also learn about the safety of HCQ plus Pred. The main questions it aims to answer are:
Does HCQ plus Pred raise the response rate in participants, compared to Pred alone? Does HCQ plus Pred prolong the response duration in participants, compared to Pred alone? What medical problems do participants have when taking HCQ plus Pred? Researchers will compare HCQ plus Pred with Pred alone to see if HCQ plus Pred works better to treat primary immune thrombocytopenia with positive anti-nuclear antibodies.
Participants will:
Take Pred every day for 6 weeks, 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 Pred raise the response rate in participants, compared to Pred alone? Does HCQ plus Pred prolong the response duration in participants, compared to Pred alone? What medical problems do participants have when taking HCQ plus Pred? Researchers will compare HCQ plus Pred with Pred alone to see if HCQ plus Pred works better to treat primary immune thrombocytopenia with positive anti-nuclear antibodies.
Participants will:
Take Pred every day for 6 weeks, 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 by a decreased peripheral platelet count and an increased risk of bleeding. It has been reported that 33.3% -39.2% of ITP patients have positive antinuclear antibodies (ANA) in the course of the disease.In the meantime, they do not meet the diagnostic criteria for rheumatic diseases such as lupus erythematosus(SLE). ITP patients with positive ANA are prone to relapse and chronicity. Therefore, it is necessary to explore new clinical treatments to attain long-term remission in these patients.
Hydroxychloroquine (HCQ) has immune modulating role on a variety of immune cells.A 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 good tolerance. In conclusion, it can be seen that HCQ and prednisone 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 cells.A 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 good tolerance. In conclusion, it can be seen that HCQ and prednisone 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:
True
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?: