NCT02444728

Cyclophosphamide and Hydroxychloroquine for Thrombocytopenia in SLE

Cyclophosphamide and Hydroxychloroquine for the Treatment of Severe Thrombocytopenia in Systemic Lupus Erythematosus

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Chinese SLE Treatment And Research Group · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Treating severe thrombocytopenia is a challenge in the management of systemic lupus erythematosus. Although rheumatologists have followed some rules in real practice,there is very few evidence to support the current treatment algorithm. The purpose of this study is to compare the complete remission rate and partial remission rate of cyclophosphamide and hydroxychloroquine for treating severe thrombocytopenia in Chinese SLE patients.

Detailed description

This is a prospective,randomized,open-label,multi-center clinical trial. The aim of this study is to test the efficacy of GC(gluco-corticosteroid)+HCQ(hydroxychloroquine) and GC(glucocorticosteroid)+CTX(cyclophosphamide) with sequential AZA(azathioprine) in the induction and maintenance therapy of severe thrombocytopenia in SLE patients.

Conditions

• Thrombocytopenia

Interventions

Type	Name	Description
DRUG	Hydroxychloroquine	Hydroxychloroquine 200 mg BID for 12 months
DRUG	Cyclophosphamide	Cyclophosphamide 1000mg intravenous infusion every month for 6 months
DRUG	Azathioprine	After Cyclophosphamide treatment, Azathioprine 100mg once daily for 6 months
DRUG	Methylprednisolone	Methylprednisolone 40-50 mg once daily for 1 months and then taped for 12 months

Timeline

• Start date: 2015-07-01
• Primary completion: 2018-12-30
• Completion: 2018-12-30
• First posted: 2015-05-14
• Last updated: 2022-03-14

Locations

15 sites across 1 country: China