EUCTR2007-005089-12-FR进行中（未招募）不适用
Study title: Double-blind vs Placebo, Randomized, Exploratory Study toAssess the Short Term Effect on Liver Enzymes and the Safety ofTRO19622 500 mg QD for One Month in Patients with Non-AlcoholicSteatohepatitis (NASH).
TROPHOS0 个研究点开始时间: 2007年10月4日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Adult subjects older than 18 years.
- •2. Persistent ALT elevation (> 2x the upper limit normal of the local laboratory of the investigating site , ie > 70 U/L for males and > 54 U/L for females at Salpétrière) over 6 months prior to entry into study. No more than one ALT value within the normal range in the past year.
- •3. Histologically confirmed diagnosis of steatohepatitis (Brunt et al. criteria
- •- Am J Gastroenterol 1999;94(9)2467-74) on biopsy within 2 years prior to entry into
- •4. Compensated liver disease with the following hematologic, biochemical, and serological criteria on entry into protocol:
- •Hemoglobin > 11 gm/dL for females and > 12 gm/dL for males
- •White blood cell (WBC) > 2.5 K/UL
- •Neutrophil count > 1.5 K/UL
- •Platelets > 100 K/UL
- •Total bilirubin < 35µmol/L)
- •Albumin > 36 g/L
- •TP> 80% .
- •Serum creatinine within normal limits
- •5. No other cause of chronic liver disease (autoimmune, primary biliary cirrhosis, HBV, Wilson, a-1-antitrypsin deficit, hemochromatosis etc. . . )
- •6. If applicable, have a stable diabetes, defined as HgbA1c < 9% and fasting glycemia <10 mmol/L, no changes in medication in the previous 6 months, and no new symptoms associated with diabetes in the previous 3 months.
- •7. If applicable have a stable metabolic condition (diagnosis made at least 6 months before inclusion), without major weight or laboratory tests changes.
- •8. Negative pregnancy test or post menopausal.
- •9. Have an electrocardiogram (ECG) without any clinically significant abnormality.
- •10. Subjects must be willing to give written informed consent.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Evidence of another form of liver disease.
- •2. History of excess alcohol ingestion: daily alcohol consumption > 30 g/day (3 drinks per day) for males and > 20 g/day (2 drinks/day) for females.
- •3. Unstable metabolic condition: Weight change > ±10% in the previous year, diabetes with poor glycemic control (HgbA1c > 9%), introduction of an antidiabetic or of an anti-obesity drug in the past 6 months prior to screening.
- •4. History of gastrointestinal bypass surgery or ingestion of drugs known to produce hepatic steatosis including corticosteroids, high-dose estrogens, methotrexate, tetracycline or amiodarone in the previous 6 months.
- •5. Significant systemic or major illnesses other than liver disease, including congestive heart failure, coronary artery disease, cerebrovascular disease, pulmonary disease, renal failure, organ transplantation, serious psychiatric disease, malignancy that, in the opinion of the investigator would preclude treatment with TRO19622 and/or adequate follow up.
- •6. HIV infection.
- •7. Active substance abuse, such as inhaled or injection drugs within the previous year.
- •8. Pregnancy or inability to practice adequate contraception in women of child-bearing potential.
- •9. Active malignancy except cutaneous basocellular carcinoma.
- •10. Any other condition which, in the opinion of the investigator would impede competence or compliance or possibly hinder completion of the study.
- •11. Body mass index (BMI) >40 kg/m2 (obesity Grade III).
- •12. Type 1 diabetes or Insulin-treated type 2 diabetes.
- •13. Hemostasis disorders or current treatment with anticoagulants.
- •14. History of, or current cardiac dysrhythmias and / or a history of cardiovascular disease, including myocardial infarction, except patients with only well controlled hypertension.
- •15. Participation in any other investigational drug or therapy study within the previous 3 months.
- •16. Be possibly dependent on the Investigator or the Sponsor (eg, including, but not limited to, affiliated employee).
- •17. Medications that could interfere with TRO19622 absorption
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