EUCTR2018-004012-22-ES进行中（未招募）1 期
A Phase 3, Multinational, Double-Blind, Randomized, Placebo-Controlled Study of MGL-3196 (resmetirom) in Patients With Non-Alcoholic Steatohepatitis (NASH) and Fibrosis to Resolve NASH and Reduce Progression to Cirrhosis and/or Hepatic Decompensation
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 2,000
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
- •Only evaluate patients for study participation if they meet the Prescreening Criteria.
- •Patients who do not initially meet eligibility criteria may be retested, based on Investigator judgment, to determine if they qualify to participate. Patients who meet all of the following criteria will be eligible to participate in the study:
- •1. Must be willing to participate in the study and provide written informed consent.
- •2. Male and female adults =18 years of age.
- •3. Female patients are eligible if they are of reproductive potential and have a negative serum pregnancy test (beta human chorionic gonadotropin), are not breastfeeding, and do not plan to become pregnant during the study and agree to use 2 highly effective birth control methods during the study OR if they are not of child bearing potential (i.e., surgically [bilateral oophorectomy, hysterectomy, or tubal ligation] or naturally sterile [>12 consecutive months without menses]). Highly effective birth control methods include condoms with spermicide, diaphragm with spermicide, hormonal and non-hormonal intrauterine device, hormonal contraception (estrogens stable =3 months), a vasectomized partner, or sexual abstinence (defined as refraining from heterosexual intercourse), throughout the study and for at least 30 days after study drug administration. Reliance on abstinence from heterosexual intercourse is acceptable only if it is the subject’s habitual practice.
- •4. Male subjects who are sexually active with a partner of child-bearing potential must either be sterile (vasectomy with history of a negative sperm count at least 90 days following the procedure); practice total abstinence from sexual intercourse as the preferred lifestyle (periodic abstinence is not acceptable); use a male condom with any sexual activity; or agree to use a birth control method considered to be appropriate by the Investigator (such as one of the methods identified above for female subjects of childbearing potential) from the time of Screening until 30 days after the last dose of study drug administration. Male subjects must agree not to donate sperm for a period of 30 days after the last dose of study drug administration.
- •5. Suspected or confirmed diagnosis of NASH suggested by the historical data assessed in the following order. Subjects MUST meet both criterion 5 (a) and (b) BEFORE obtaining an MRI-PDFF (criterion 6) or liver biopsy (criterion 7).
- •a. First: Meet metabolic risk factors and elevated liver enzyme (AST) as part of Prescreening criteria.
- •b. Second: Meet one of the following that is consistent with liver fibrosis:
- •?Biochemical test for fibrosis: PRO-C3 >14 ng/mL; or ELF =9.
- •?Fibroscan with transient elastography =8.5 kPa; and controlled attenuation parameter =300 dB.m-1
- •?Historical liver biopsy obtained >24 weeks and < 2 years before expected randomization showing Stage 2 or 3 fibrosis with no significant change in body weight >5% or medication that might affect NAS or fibrosis stage. NOTE: This biopsy is not eligible for study entry because it was obtained > 24 weeks before expected randomization; however the biopsy is evidence of existing NASH fibrosis.
- •6. MRI-PDFF fat fraction =8% obtained during the screening period (Baseline MRI-PDFF). NOTE: To be eligible to perform the screening
排除标准
- •Patients who meet any of the following criteria will be excluded from participation in the study. Patients who do not initially meet eligibility criteria may be retested or rescreened, based on Investigator judgment, to determine if they qualify to participate.
- •2. Regular use of drugs historically associated with NAFLD, which include but are not limited to the following: amiodarone, methotrexate, systemic glucocorticoids at greater than 5 mg/day, tetracyclines, tamoxifen, estrogens at doses greater than those used for hormone replacement or contraception, anabolic steroids except testosterone replacement, valproic acid, and known hepatotoxins for more than 4 weeks within the last 8 weeks prior to the initial Screening.
- •4.History of bariatric surgery or intestinal bypass surgery within the 5 years prior to randomization or planned during the conduct of the study.
- •5.Weight gain or loss =5% total body weight within 12 weeks prior to randomization.
- •7.Glucagon-like peptide 1 [GLP-1] agonist therapy (e.g., exenatide, liraglutide, lixisenatide, albiglutide, dulaglutide, semaglutide and albiglutide) unless stable dose for 24 weeks prior to biopsy. GLP-1 therapeutics may not be initiated or doses increased during the first 52 weeks of the study.
- •9.Presence of cirrhosis on liver biopsy defined as stage 4 fibrosis.
- •10.Diagnosis of hepatocellular carcinoma (HCC).
- •13.Chronic liver diseases:
- •a.Primary biliary cholangitis
- •b.Primary sclerosing cholangitis
- •c.Hepatitis B positive (as defined in Appendix 3)
- •d.Hepatitis C as defined by presence of hepatitis C virus (HCV) antibody (HCV Ab) or positive HCV RNA (tested for known cured HCV infection, or positive HCV Ab at Screening). NOTE: Patients with positive anti-HCV who test negative for HCV RNA at Screening will be allowed to participate in the study. If prior treatment for HCV, a documented sustained virologic response (SVR) must be available and the patient must have achieved this SVR at least 2 years prior to the qualifying liver biopsy.
- •e.History or evidence of current active autoimmune hepatitis
- •f.History or evidence of primary biliary cholangitis
- •g.History or evidence of primary sclerosing cholangitis
- •h.History or evidence of Wilson's disease
- •i.History or evidence of alpha-1-antitrypsin deficiency
- •j.Evidence of hemochromatosis
- •k.History or evidence of drug-induced liver disease, as defined on the basis of typical exposure and history
- •l.Known bile duct obstruction
- •m.Suspected or proven liver cancer.
- •15.Serum ALT >250 U/L.
- •NOTE:Must have documented historical (3 weeks to 6 months prior to the study entry) ALT and AST levels consistent with the Screening ALT and AST values. This consistency is established based on the following:
- •oIf the historical and Screening ALT and AST values are both =1.5 × ULN, there is no limit to the difference between the values.
- •oIf the historic ALT/AST are >1.5 × elevated and Screening ALT and AST are markedly improved (>50% decreased or normalized) relative to historic, then a third ALT/AST determination will be made during Screening to assure a st
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