The Efficacy and Safety of HCQ Plus DEX in ANA Positive ITP
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 resp
| Condition(s) | Immune Thrombocytopenia With Positive ANA Antibodies |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| 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 |
| Who can participate | Inclusion Criteria: 1. Age is between 15-75 years old, and gender is unlimited. 2. Before randomization, the clinical diagnosis is primary immune thrombocytopenia. The platelet count is less than 30×10\^9 / L within 1 week before enrollment, or platelet count is less than 50×10\^9 / L with bleeding symptoms within 1 week before enrollment. 3. The antinuclear antibody is positive. 4. Other autoantibodies (mainly including dsDNA antibodies, SSA, SSB, RNP, β 2-GP, ACA, ANCA) are negative. 5. Prothrombin time does not exceed ± 3s of the normal value ranget, activated partial thrombin time is not outside normal range ± 10s; no history of coagulopathy except ITP. 6. Understand the study procedures and sign the written informed consent form. Exclusion Criteria: 1. Secondary thrombocytopenia cause |
| Ages | 15 Years to 75 Years |
| Sex | All |
| Lead sponsor | Yunfeng Cheng |
| Locations | Shanghai, Shanghai Municipality, China; Shanghai, Shanghai Municipality, China; Shanghai, Shanghai Municipality, China; Shanghai, Shanghai Municipality, China; Hong Kong, Hong Kong; Macao, Macau (+1 more sites) |
| Start date | 2024-04-24 |
| NCT ID | NCT06479317 |
| Official listing | https://clinicaltrials.gov/study/NCT06479317 |