NL-OMON53971撤回2 期
A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multiple-dose Phase 2 Study to Evaluate the Efficacy and Safety of BMS-986263 in Adults with Compensated Cirrhosis from Nonalcoholic Steatohepatitis (NASH) - IM025-017
Bristol-Myers Squibb0 个研究点目标入组 6 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 入组人数
- 6
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •*Male and female participants, ages >= 21 years to <= 75 years of age, inclusive,
- •at the time of screening;
- •*Liver biopsy performed within 12 months prior to the screening visit or
- •performed during the screening period. A liver biopsy performed prior to
- •informed consent form, if utilized for eligibility, must be available for
- •central pathology reading prior to Randomization.
- •i) Liver biopsy consistent with NASH Clinical Research Network (CRN)
- •Score Stage 4, as assessed by central pathology reading.
- •ii) Liver biopsy must either be consistent with steatohepatitis, as
- •assessed by central
- •pathology reading, OR, for liver biopsies without definite steatohepatitis,
- •there should
- •be some evidence of steatosis and/or ballooning and the following definition of
- •cirrhosis must be fulfilled:
- •(1) Absence of other causes of liver disease AND either of the
- •(a) At least 2 of the 3 following criteria:
- •(i) History of body mass index [BMI] >= 30 kg/m2
- •(ii) History of type 2 diabetes mellitus
- •(iii) History of hypertension AND/OR history of
- •dyslipidemia
- •(b) Previous histologic readings of steatohepatitis (for
- •biopsies > 12 months prior to screening visit) AND either history of BMI >= 30
- •kg/m2 OR history
- •of type 2 diabetes mellitus.
- •NOTE: At least 80% of participants will be required to have definite
- •steatohepatitis on
- •the biopsy used to confirm eligibility.
排除标准
- •*Other active causes of liver disease (eg, alcoholic liver disease, hepatitis B
- •virus infection, chronic hepatitis C virus infection, autoimmune hepatitis,
- •primary biliary cholangitis, primary sclerosing cholangitis, drug-induced
- •hepatotoxicity, Wilson disease, homozygous a-1-
- •antitrypsin deficiency, iron overload [with blood iron saturation > 50%], or
- •hemochromatosis)
- •* Past or current evidence of hepatic decompensation (eg, ascites, variceal
- •bleeding, hepatic encephalopathy, or spontaneous bacterial peritonitis)
- •* Liver transplantation (past or planned)
- •* Child-Pugh Score > 6 at screening. Participants with a Child-Pugh Score > 6
- •with elevated total bilirubin and who have Gilbert Syndrome and direct
- •bilirubin <= the upper limit of normal (ULN) may be included after discussion
- •with the Medical Monitor
- •* Model for End-stage Liver Disease (MELD) score > 14 at screening.
- •Participants with a MELD Score > 14 with elevated total bilirubin and who have
- •Gilbert Syndrome and direct bilirubin <= the ULN may be included after
- •discussion with the Medical Monitor
- •* Evidence of HCC at screening based on (i) serum alpha-fetoprotein (AFP) > 20
- •(> 16.5 IU/mL) or (ii) Liver Reporting & Data System 3, 4, or 5 as determined
- •by historical computed tomography (CT)/magnetic resonance imaging (MRI) within
- •3 months prior to screening or from multiphasic CT/MRI of liver during screening
- •* The participant*s laboratory test results at screening include any of the
- •* Albumin < 2.8 g/dL
- •* INR > 2.2
- •* Alanine aminotransferase value >= 5× the ULN
- •* Aspartate aminotransferase value >= 5× the ULN
- •* Total bilirubin > 3.0 mg/dL, unless participant has a diagnosis of Gilbert
- •Syndrome and direct bilirubin <= ULN
- •* Platelet count < 85,000/µL
- •* Hemoglobin A1c >= 9.0%
- •* Serum vitamin A (retinol) > ULN
- •* Inability to safely undergo a liver biopsy in the opinion of the
- •investigator.
研究者
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