CTRI/2018/05/013619尚未招募3 期
Open label study comparing the efficacy of Tacrolimus andtadalafil versus oral Mycophenolate in patients of systemicsclerosis with ILD
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- Self
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
入选标准
- •42 Patients with systemic sclerosis (fulfilling 2013 ACR/EULAR classification
- •criteria) between age of 18 to 60 years.
- •1. Having evidence of ILD in HRCT
- •2. Pulmonary function test (PFT) showing Forced Vital Capacity (FVC)<= 80% predicted
- •& DLCO <= 70 % of predicted.
排除标准
- •1. Those who cannot perform PFT or 6 min walk test at baseline
- •2. FVC <45% of predicted or DLCO (Hg-corrected) <40% of predicted.
- •3. Taken high dose prednisolone (1 mg/kg) or cyclophosphamide ( >500 mg) or MMF ( >
- •500mg/d) or azathioprine ( >1 mg/kg) for more than 4 weeks anytime within previous
- •4. SBP < 90 mmHg or history of orthostatic hypotension
- •5. Serum creatinine >=2.0 mg/dl
- •6. Obstructive lung disease (FEV1/FVC ratio < 0.6),
- •7. Received prostacyclins or endothelin antagonists or any investigational drug within
- •the prior month.
- •8. History of acute coronary or cerebrovascular event within 3 months
- •9. Evidence of malignancy, peptic ulcer, renal or hepatic dysfunction.
- •10. Prednisolone (for indications other than ILD) will be allowed up to 10 mg/d in all
- •11. All the married women of reproductive age group will undergone pregnancy testing
- •and will be advised non-hormonal contraception during the study period.
研究者
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