An interventional study of Hydroxychloroquine Oral Tablet and Dexamethasone oral in Immune Thrombocytopenia With Positive ANA Antibodies, sponsored by Yunfeng Cheng. Recruiting at 7 sites in 3 countries. Open to participants aged 15 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-06-28.
Sponsored by Yunfeng Cheng · Not applicable, Interventional, and Treatment
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 30×10\^9/L 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.
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 33.3% -39.2% of ITP patients have positive antinuclear antibodies (ANA) in the course of 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 longer-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 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.
697 studies on the registry are indexed under Thrombocytopenia; 153 are open to participants now.
This study's planned enrollment of 129 is above the median of 55 across 472 interventional studies indexed under Thrombocytopenia.
Browse Thrombocytopenia studies →Yunfeng Cheng is the lead sponsor of 3 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
This group is experiment group. Participants will take DEX every day for consecutive 4 days ( if platelet count does not recover higher than 30×10\^9/L after 2 weeks, take DEX every day for another consecutive 4 days) with HCQ twice a day for 1 year
Drug: Hydroxychloroquine Oral Tablet · Drug: Dexamethasone oral
This group is control group.Participants will take DEX every day for consecutive 4 days ( if platelet count does not recover higher than 30×10\^9/L after 2 weeks, take DEX every day for another consecutive 4 days)
Drug: Dexamethasone oral
Hydroxychloroquine is taken at the dose of 0.1g / dose, twice a day for 1 year, regardless of food intake.
Also known as: Hydroxychloroquine
Dexamethasone is given at 40mg every morning after meals for 4 consecutive days( if platelet count does not recover higher than 30×10\^9/L after 2 weeks, dexamethasone is given 40mg every day for another consecutive 4 days).
Also known as: Dexamethasone
Overall response rate
The percentage of participants with platelet counts higher than 30×10\^9/L and at least twice the baseline platelet count , for at least two consecutive tests (7 days apart).
Time frame: 4 weeks
Complete response rate
The percentage of participants with platelet counts higher than 100×10\^9/L , for at least two consecutive tests (7 days apart).
Time frame: 1 year
Duration of response
Time from response to disease relapse (platelet count ≤ 30×10\^9/L on any test or occurance of bleeding symptoms )
Time frame: 1 year
Durable response rate
Percentage of patients with complete remission lasting at least 6 months without any additional ITP-specific therapy
Time frame: 1 year
Platelet count at each visit
Average platelet count at each visit
Time frame: 1 year
Time to response
Time from starting treatment to response
Time frame: 4 weeks
Response rate throughout the trial
The percentage of response participants (platelet counts higher than 30×10\^9/L and at least twice the baseline platelet count ) at each visit
Time frame: 1 year
WHO bleeding score
WHO bleeding score at each visit
Time frame: 1 year
Adverse reaction
Adverse reaction at each visit
Time frame: 1 year
Plan to share: Yes
Supporting information: Study protocol, Sap, Icf, Csr, Analytic code
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