ACTRN12619000701123招募中3 期
A randomised controlled trial of Testosterone Undecanoate therapy for the treatment of non-alcoholic fatty liver disease (TNT)
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 75 Years（—）
- 性别
- Male
入选标准
- •1) Men with estimated hepatic steatosis greater than or equal to 30% by meeting 1 of the following criteria:
- •a. Diffuse increased echogenicity of the liver parenchyma on ultrasound as compared to echogenicity of renal cortex or spleen
- •b. Reduced attenuation on CT scan (less than or equal to 40 Houndsfield units)
- •c. Controlled attenuation parameter on fibroscan above 270dB/m
- •2) Age 18 to 75 years of age.
- •3) Plasma total testosterone less than or equal to 12nmol/L or free testosterone less than or equal to 230pmol/L on two occasions.
- •4) Fibroscan greater than or equal to 7.0kPa OR ALT greater than or equal to 30u/L, to identify men at risk of progression of liver disease.
排除标准
- •1) Alcohol consumption >21 units per week >2 weeks in the last year or >3 months of the past 5 years to exclude inadvertent inclusion of patients with alcoholic liver disease
- •2) Other significant cause for liver disease, including autoimmune liver disease, metabolic liver disease such as Wilson’s disease or hereditary haemachromatosis, or viral hepatitis (excluding Hepatitis C virus treated >12 months ago)
- •3) Prostate cancer, elevated PSA or abnormal prostate on digital rectal exam
- •4) Hepatocellular or other active cancer
- •5) Current or previous (within 12 months) testosterone or androgen deprivation therapy
- •6) Severe renal impairment (eGFR <30ml/min)
- •7) Symptomatic ischaemic heart disease or significant heart failure symptoms (New York Heart Association class III or IV)
- •8) Uncontrolled hypertension >160/100mHg
- •9) Uncontrolled obstructive sleep apnoea
- •10) Decompensated cirrhosis, as evidence by Child Pugh Score B or C, given risk of death or transplantation within the study period
- •11) Contraindications to MRI (non-MRI-compatible pacemaker or other device, severe claustrophobia, inability to breath hold)
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