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Efficacy and safety of hydroxychloroquine combined with prednisone in first-line treatment of primary immune thrombocytopenia

Efficacy and safety of hydroxychloroquine combined with prednisone in first-line treatment of primary immune thrombocytopenia: a multicenter, randomized, controlled clinical study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300068387
Enrollment
Unknown
Registered
2023-02-16
Start date
2023-03-01
Completion date
Unknown
Last updated
2023-05-22

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

Conditions

primary immune thrombocytopenia

Interventions

Group 1:Hydroxychloroquine and prednisone
Group 2:prednisone

Sponsors

The Second Affiliated Hospital of Kunming Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: (1) 18-70 years old, male or female; (2) Newly diagnosed primary ITP; (3) Platelet count =30×109/L or platelet count <50×109/L accompanied with bleeding symptoms; (4) Be able to understand the procedures and methods of this study, sign the informed consent voluntarily and strictly abide by the clinical trial protocol; (5) Subjects agree to use effective contraceptive measures during the trial period and for 6 months after the end of the last medication.

Exclusion criteria

Exclusion criteria: (1) Secondary ITP; (2) Pregnancy or lactation; (3) hypersensitivity to glucocorticoid or hydroxychloroquine; (4) Hepatitis B,Cor HIV infection; (5) Contraindication of glucocorticoid: such as diabetes, poorly controlled hypertension, glaucoma, active gastrointestinal ulcer, severe osteoporosis, active tuberculosis or other uncontrolled diseases, etc.; (6) Contraindications of hydroxychloroquine: macular degeneration of fundus; (7) severe mental illness or epilepsy; (8) Other Conditions that researchers consider unsuitable for participating in the study.

Design outcomes

Primary

MeasureTime frame
Sustained response rate;

Secondary

MeasureTime frame
Initial response rate ;Time to response;Duration of reaction;

Countries

China

Contacts

Public ContactBi Hui

The Second Affiliated Hospital of Kunming Medical University

bihui1971@163.com13888430152

Outcome results

None listed

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