Trial | NCT02444728  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Terminated

  • Study Participants

    50
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.
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.
Study Started
Jul 31
2015
Primary Completion
Dec 30
2018
Study Completion
Dec 30
2018
Last Update
Mar 14
2022

Drug Hydroxychloroquine

Hydroxychloroquine 200 mg BID for 12 months

  • Other names: Fenle

Drug Cyclophosphamide

Cyclophosphamide 1000mg intravenous infusion every month for 6 months

  • Other names: Huanlinxianan

Drug Azathioprine

After Cyclophosphamide treatment, Azathioprine 100mg once daily for 6 months

  • Other names: liuzuopiaolin

Drug Methylprednisolone

Methylprednisolone 40-50 mg once daily for 1 months and then taped for 12 months

  • Other names: meizhuole

Group1:Hydroxychloroquine Active Comparator

Hydroxychloroquine: 100 mg tablets by mouth, 400mg everyday for 12 months Methylprednisolone: 4 mg tablets by mouth, 40-50mg everyday and tapering for 12 months

Group 2:Cyclophosphamide Active Comparator

Cyclophosphamide, Azathioprine & Methylprednisolone Cyclophosphamide: 200mg powder intravenous infusion, 1000mg every month for 6 month. Azathioprine: 100 mg tablets by mouth, everyday for 6 months. Methylprednisolone: 4 mg tablets by mouth, 40-50mg everyday and tapering for 12 months

Criteria 

Inclusion Criteria:

Patients fulfilled the 1997 ACR modified or SLICC classification criteria of SLE；
New onset thrombocytopenia: platelet count <30X109/L(by both routine test and citric acid anti-coagulated blood count test) within 3 months

Exclusion Criteria:

Thrombocytopenia caused by other reasons, including drugs；
Positive for active HAV(hepatitis A virus)/HBV(hepatitis B virus) infection
Active HIV(human immunodeficiency virus) or HCV(hepatitis C virus) infection;
Active HP(Helicopter pylori) infection;
Severe liver and kidney dysfunction；
Severe neuropsychiatric lupus；
No response to high dose steroid and/or cyclophosphamide 1 month prior to study enrollment；
Uncontrolled diabetes or hypertension before entry
Active GI bleeding 3 months before entry
Intolerant to HCQ in the past treatment history；
Severe bone marrow suppression or liver damage caused by cyclophosphamide in the past history；
Active infection , including bacteria, virus, fungi, mycobacteria
Allergy to any of the study medications
Confirmed TTP(thrombolic thrombocytopenic purpura)or CAPS(catastrophic anti-phosphilipid syndrome)
Platelet count less than 20X109/L with active bleeding
Myelodysplastic diseases
Patients with heart and lung function impairment
thiopurine S-methyltransferase (TPMT) gene positive -
No Results Posted