EUCTR2016-000821-37-AT进行中（未招募）1 期
A Phase 2, Double-Blind, Randomized Study Evaluating the Safety, Tolerability, and Efficacy of GS-4997 in Combination with Prednisolone versus Prednisolone Alone in Subjects with Severe Alcoholic Hepatitis (AH)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 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 clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1) Males and non-pregnant, non-lactating females between 18-70 years of age, inclusive based on the date of the screening visit;
- •2) Willing and able to give informed consent prior to any study specific procedures being performed. In subjects with hepatic encephalopathy (HE), which may impair decision-making, consent will be obtained per hospital procedures (eg, by legal Authorized Representative);
- •3) Clinical diagnosis of severe AH
- •4) All female subjects of childbearing potential must agree to use a highly effective method of contraception during intercourse from the screening visit throughout the study period and for 90 days following the last dose of study drug. If females utilize hormonal agents as one of their contraceptive methods, the same hormonal methods must have been used for at least 3 months before study dosing. Females on hormonal methods must also utilize a barrier method as another form of contraception;
- •5) Male subjects must refrain from sperm donation from screening through at least 90 days following the last dose of study drug;
- •6) Male subjects must agree to use condoms during intercourse from screening through study completion and for 90 days following the last dose of study drug;
- •7) Female subjects must refrain from egg donation or harvest for 90 days after last dose of study drug;
- •8) Willing and able to comply with scheduled visits, drug administration plan, laboratory tests, other study procedures, and study restrictions
- •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 108
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 12
排除标准
- •1) Pregnant or lactating females;
- •2) Other causes of liver disease including chronic hepatitis B (hepatitis B surface antigen [HBsAg] positive), chronic hepatitis C (HCV RNA positive), acetaminophen hepatotoxicity, biliary obstruction, and autoimmune liver disease;
- •3) Serum AST >400 U/L or ALT > 300 U/L;
- •4) MELD > 30 at screening;
- •5) Maddrey's DF > 60 at screening;
- •6) Grade 4 HE by West Haven criteria;
- •7) Concomitant or previous history of hepatocellular carcinoma;
- •8) History of liver transplantation;
- •9) HIV Ab positive;
- •10) Clinical suspicion of pneumonia;
- •11) Uncontrolled sepsis;
- •12) Uncontrolled gastrointestinal (GI) bleeding or controlled GI bleeding within 7 days of screening that was associated with shock or required transfusion of more than 3 units of blood;
- •13) Type 1 hepatorenal syndrome (HRS) or renal failure defined as a serum creatinine >221 µmol/L (> 2.5 mg/dL) or the requirement for renal replacement therapy;
- •14) Subjects dependent on inotropic (eg, epinephrine or norepinephrine) or ventilatory support (ie, endotracheal intubation or positive-pressure
- •ventilation);
- •15) Portal vein thrombosis;
- •16) Acute pancreatitis;
- •17) Cessation of alcohol consumption for more than 2 months before baseline/Day 1;
- •18) Severe associated disease (eg, cardiac failure, acute myocardial infarction, severe cardiac arrhythmias, severe pulmonary disease, neurologic disease,) that may lead to premature mortality within the study period;
- •19) Malignancy within the 2 years prior to screening, with the exception of specific cancers that have been cured by surgical resection (basal cell
- •skin cancer, etc). Subjects under evaluation for possible malignancy are not eligible.
- •20) Positive urine screen for amphetamines, cocaine or opiates (ie, heroin, morphine) at screening. Subjects on stable methadone or buprenorphine maintenance treatment for at least 6 months prior to screening may be included in the study. Subjects with positive cannabis
- •drug screen may be included in the study. Subjects with a positive urine drug screen due to prescription opioid-based medication are eligible if the prescription and diagnosis are reviewed and approved by the investigator;
- •21) Treatment with immunosuppressive drugs [budesonide, tacrolimus, sirolimus, cyclosporine, azathioprine, mycophenolate mofetil, and
- •methotrexate], pentoxifylline, N-acetylcysteine (NAC), or granulocyte (macrophage) colony-stimulating factor within 6 months of Screening.
- •Subjects will be eligible to enroll if systemic corticosteroids were started within 3 days prior to the Baseline/Day 1 visit. Inhaled and topical
- •corticosteroids are allowed;
- •22) Use of strong CYP3A4 inducers (eg, carbamazepine, phenytoin, rifampin, St. John's Wort) within 2 weeks of the Baseline/Day 1;
- •23) Active ocular herpes simplex;
- •24) Any laboratory abnormality or condition that, in the investigator's opinion, could adversely affect the safety of the subject or impair the
- •assessment of study results;
- •25) Participation in another investigational study of a drug or device within 1 month prior or within 5 half-lives of the prior investigational
- •agent (whichever is longer) prior to screening;
- •26) Concurrent participation in another therapeutic clinical study;
- •27) Known hypersensitivity to the study drugs (GS-4997 and prednisolone), the metabolites, or formulation excipient;
- •28) Presence of any condition that could, in the opinion of the investigator, compromise the subject's ability to participat
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