Efficacy and safety study of corticosteroids plus hydroxychloroquine in first-line treatment of patients with primary immune thrombocytopenia with positive antinuclear antibody

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2100045747

Enrollment

Unknown

Registered

2021-04-23

Start date

2020-12-01

Completion date

Unknown

Last updated

2021-12-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

primary immune thrombocytopenia

Interventions

Experimental group:hydroxychloroquine + Dexamethasone

Control group:Dexamethasone

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Newly diagnosis ITP patients; 2.Platelet count30x10^9/L, accompanied with bleeding; 3.Antinuclear antibodies 1:100~1:320 positive; 4.Other auto-antibodies negative (dsDNA antibody, SSA, SSB, RNP, ß2-GP, ACA, ANCA).

Exclusion criteria

Exclusion criteria: 1.Pregnant or lactating female patients; 2.Patients accompanied with malignant tumor; 3.G-6PD patients; 4.Patients with retinal or visual field diseases caused by 4-aminoquinoline compound; 5.Patients allergic to 4-aminoquinoline compound; 6.Secondary thrombocytopenia; 7.Patients with diagnosed rheumatoid diseases.

Design outcomes

Primary

Measure	Time frame
response rate;response duration;	—

Secondary

Measure	Time frame
adverse reation;	—

Countries

China

Contacts

Public ContactCheng Yunfeng

Zhongshan Hospital, Fudan University

yfcheng@fudan.edu.cn+86 15921398238

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026