Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2/PHASE3
54 participants
INTERVENTIONAL
2023-02-28
2024-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Hydroxychloroquine monotherapy
Oral hydroxychloroquine 200mg twice daily for 12 weeks.
Hydroxychloroquine
Oral hydroxychloroquine 200mg twice daily for 12weeks.
Tacrolimus monotherapy
Oral tacrolimus 1-2mg twice daily for 12 weeks.
Tacrolimus
Oral Tacrolimus 1-2mg twice daily for 12 weeks.
Interventions
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Hydroxychloroquine
Oral hydroxychloroquine 200mg twice daily for 12weeks.
Tacrolimus
Oral Tacrolimus 1-2mg twice daily for 12 weeks.
Eligibility Criteria
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Inclusion Criteria
* Baseline platelet counts within 30-80×109/L.
Exclusion Criteria
* Severe complications of Sjogren's syndrome.
* Abnormal laboratory tests such as: white blood cell count \<2.5x10\^9/L, hemoglobin \<80 g/L, AST/ALT \>1.5 ULN, serum creatine \> 1.5 mg/dL.
* Received glucocorticoids, immunosuppressants, or biological agents within 3 months.
* Active acute or chronic infections.
* History of malignancy.
* Pregnancy or breastfeeding.
18 Years
70 Years
ALL
No
Sponsors
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Peking Union Medical College Hospital
OTHER
Responsible Party
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Wen Zhang
Prof.
Central Contacts
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Other Identifiers
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I-22PJ1065
Identifier Type: -
Identifier Source: org_study_id
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