Cyclophosphamide and Hydroxychloroquine for Thrombocytopenia in SLE

• Status: Unknown status
• Trial end date: 2018-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chinese SLE Treatment And Research Group
• Collaborator: Peking Union Medical College Hospital
• Treatments: Azathioprine; Cyclophosphamide; Hydroxychloroquine; Methylprednisolone; Methylprednisolone acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate

Criteria

Inclusion Criteria:

1. Patients fulfilled the 1997 ACR modified or SLICC classification criteria of SLE；

2. New onset thrombocytopenia: platelet count <30X109/L(by both routine test and citric acid anti-coagulated blood count test) within 3 months

Exclusion Criteria:

1. Thrombocytopenia caused by other reasons, including drugs；

2. Positive for active HAV(hepatitis A virus)/HBV(hepatitis B virus) infection

3. Active HIV(human immunodeficiency virus) or HCV(hepatitis C virus) infection;

4. Active HP(Helicopter pylori) infection;

5. Severe liver and kidney dysfunction；

6. Severe neuropsychiatric lupus；

7. No response to high dose steroid and/or cyclophosphamide 1 month prior to study enrollment；

8. Uncontrolled diabetes or hypertension before entry

9. Active GI bleeding 3 months before entry

10. Intolerant to HCQ in the past treatment history；

11. Severe bone marrow suppression or liver damage caused by cyclophosphamide in the past history；

12. Active infection , including bacteria, virus, fungi, mycobacteria

13. Allergy to any of the study medications

14. Confirmed TTP(thrombolic thrombocytopenic purpura)or CAPS(catastrophic anti-phosphilipid syndrome)

15. Platelet count less than 20X109/L with active bleeding

16. Myelodysplastic diseases

17. Patients with heart and lung function impairment

18. thiopurine S-methyltransferase (TPMT) gene positive -