EUCTR2017-004365-27-FR进行中（未招募）1 期
A Phase 2 Dose Ranging, Randomized, Double Blind, and Placebo-Controlled Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of EDP-305 in Subjects with Non-Alcoholic Steatohepatitis (NASH)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 125
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
入选标准
- •1. Male and female subjects of any ethnic origin between the ages of 18 and 75 years, inclusive
- •2. Male or female with presence of NASH by:
- •- Histologic evidence on a historical liver biopsy within 24 months of Screening consistent with NASH with fibrosis (no cirrhosis), and elevated ALT at Screening
- •- Phenotypic diagnosis of NASH based on elevated ALT and diagnosis of T2DM or pre-diabetes
- •- Screening MRI PDFF with >8% steatosis
- •3. Body mass index (BMI) >25 kg/m2. NOTE: for Asian-Americans, BMI >23 kg/m2
- •4. Subjects must have Screening laboratory values for Hepatitis B surface antigen (HBsAg), anti-HCV antibodies and HCV RNA, and Human Immunodeficiency Virus (HIV) 1 and 2 antibodies (Ab) as seronegative.
- •5. Female subjects of childbearing potential must agree to use two effective methods of contraception from the date of Screening until 90 days after the last dose of EDP-305.
- •6. All male participants who have not had a vasectomy must use effective contraception from Day -1 to 90 days after their last dose of study drug.
- •7. Male subjects must agree to refrain from sperm donation from the date of Screening until 90 days after their last dose of study drug.
- •8. Subject must be willing and able to adhere to the assessments, visit schedules, prohibitions and restrictions, as described in this protocol.
- •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 100
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 25
排除标准
- •1. Laboratory Screening Results:
- •- Total bilirubin >ULN (normal range 0.2–1.2 mg/dL)
- •- Total white blood cells (WBC) <3,000 cells/mm3
- •- Absolute neutrophil count (ANC) <1,500 cells/mm3
- •- Platelet count <140,000/mm3
- •- Prothrombin time (international normalized ratio, INR)>1.2
- •- Creatine kinase above the upper limit of normal (ULN) except when in relation with intense exercise
- •- Serum creatinine >2 mg/dL or clearance creatinine <60 ml/min (based on Cockroft Gault method)
- •2. Known history of alpha-1-antitrypsin deficiency
- •3. Use of an experimental treatment for NASH within the past 6 months
- •4. Prior use and/or concurrent treatment with obeticholic acid
- •5. Use of immunosuppressant (eg, corticosteroids) for more than 2 weeks in duration within 1 year prior to Screening and during the course of the study
- •6. Use of experimental or unapproved drugs within a year of Screening
- •7. Any other condition(s) (including cardiovascular diseases) that would compromise the safety of the subject or compromise the quality of the clinical study, as judged by the Principal Investigator
- •8. Pregnant or nursing females
- •9. Recipients of liver or other organ transplantation or anticipated need for orthotropic organ transplantation in one year as determined by a Model for End-Stage Liver Disease Score =15
- •10. Clinical suspicion of advanced liver disease or cirrhosis
- •11. Coexisting liver or biliary diseases, such as primary sclerosing cholangitis, choledocholithiasis, acute or chronic hepatitis, autoimmune hepatitis, alcoholic liver disease, acute infection of bile duct system or gall bladder, history of gastrointestinal bleeding (secondary to portal hypertension), cirrhosis
- •12. Suspicion of cancer (eg, liver cancer) with the exception of basal cell carcinoma that has been resected
- •13. Cirrhosis with or without complications, including history or presence of: spontaneous bacterial peritonitis, hepatocellular carcinoma, bilirubin >2 × ULN
- •14. Hepatorenal syndrome (type I or II) or Screening serum creatinine > 2 mg/dL (178 µmol/L)
- •15. Prior variceal hemorrhage, uncontrolled encephalopathy, Child-Pugh Class A, B, and C, esophageal varices, or refractory ascites within the previous 6 months of Screening
- •16. Any condition possibly affecting drug absorption (eg, gastrectomy <3 years prior to Screening)
- •17. History of regular alcohol consumption exceeding 14 drinks/week for females and 21 drinks/week for males within 6 months of Screening.
- •18. Subject has received an investigational agent or vaccine within 30 days, or a biological product within 3 months or 5 elimination half-lives (whichever is longer) prior to the planned intake of study drug.
- •19. Clinically significant electrocardiogram abnormalities or QTcF greater than 450 ms for males and 470 ms for females at either Screening or Baseline, or any prior history of QT abnormality
- •20. Use of cytochrome P450 (CYP)3A4 and P-glycoprotein (P-gp) inducers and inhibitors within 14 days prior to the first dose of study medication and throughout study duration
研究者
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