EUCTR2018-001171-20-IT进行中（未招募）1 期
A 52-week, placebo-controlled, randomized, Phase 3 study to evaluate thesafety and efficacy of seladelpar in subjects with primary biliary cholangitis(PBC) and an inadequate response to or intolerance to ursodeoxycholicacid (UDCA). - NA
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 265
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. Must have given written informed consent (signed and dated) and any
- •authorizations required by local law
- •2. 18 to 75 years old (inclusive)
- •3. Male or female with a diagnosis of PBC, by at least two of the
- •following criteria:
- •History of AP above ULN for at least 6 months
- •Positive anti-mitochondrial antibody (AMA) titers (>1/40 on
- •immunofluorescence or M2 positive by enzyme linked immunosorbent
- •assay [ELISA]) or positive PBC-specific antinuclear antibodies
- •Documented liver biopsy result consistent with PBC
- •4. On a stable and recommended dose of UDCA for the past 12 months
- •OR intolerant to UDCA (last dose of UDCA > 3 months prior to Screening)
- •5. AP > 1.67 × ULN
- •6. Females of reproductive potential must use at least one barrier
- •contraceptive and a second effective birth control method during the
- •study and for at least 90 days after the last dose. Male subjects who are
- •sexually active with female partners of reproductive potential must use
- •barrier contraception and their female partners must use a second
- •effective birth control method during the study and for at least 90 days
- •after the last dose
- •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 200
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 40
排除标准
- •1. Previous exposure to seladelpar (MBX-8025)
- •2. A medical condition, other than PBC, that in the investigator's opinion
- •would preclude full participation in the study or confound its results
- •(e.g., cancer)
- •3. AST above 3 × ULN
- •4. ALT above 3 × ULN
- •5. Total bilirubin above 2.0 × ULN
- •6. Advanced PBC as defined by the Rotterdam criteria (albumin below
- •LLN AND total bilirubin above 1 × ULN
- •7. Creatine kinase (CK) above 1.0 × ULN
- •8. eGFR below 60 mL/min/1.73 m2 (calculated by MDRD formula) 7. Serum creatinine above 1.0 × ULN
- •9. International normalized ratio (INR) above 1.0 × ULN
- •10. Platelet count below 100 × 103/µL
- •11. Presence of clinically significant hepatic decompensation, including:
- •- History of liver transplantation, current placement on liver
- •transplantation list, or current Model for End-Stage Liver Disease (MELD)
- •- Complications of portal hypertension, including known esophageal
- •varices, history of variceal bleeds or related interventions (e.g.,
- •transjugular intrahepatic portosystemic shunt placement), relevant
- •ascites, hepatic encephalopathy
- •- Cirrhosis with complications, including history or presence of
- •spontaneous bacterial peritonitis
- •12. Other chronic liver diseases:
- •a.Current features of auto-immune hepatitis as determined by the
- •investigator based on immunoserology, liver biochemistry and histology
- •b.Primary sclerosing cholangitis determined by presence of diagnostic
- •cholangiographic findings
- •c.History or clinical evidence of alcoholic liver disease
- •d.History or clinical evidence of alpha-1-antitrypsin deficiency
- •e.Biopsy confirmed nonalcoholic steatohepatitis
- •f.History or evidence of Gilbert' Syndrome with elevated total bilirubin
- •g.History or evidence of hemochromatosis
- •h.Hepatitis B defined as presence of hepatitis B surface antigen (HBsAg)
- •i.Hepatitis C defined as presence of HCV RNA
- •13. Known history of HIV
- •14. Evidence of significant alcohol consumption
- •15. Evidence of drug abuse
- •16. Subjects with inadequate response to obeticholic acid (OCA) or
- •intolerance to OCA: OCA must be discontinued 30 days prior to Screening
- •17. Use of colchicine, methotrexate, azathioprine, or long-term systemic
- •corticosteroids (> 2 weeks) within two months prior to Screening
- •18. Use of fibrates within 30 days prior to Screening
- •19. Use of simvastatin within 7 days prior to Screening
- •20. Use of an experimental or unapproved treatment for PBC within 30
- •days prior to Screening
- •21. Use of experimental or unapproved immunosuppressant within 30
- •days prior to Screening
- •22. Treatment with any other investigational therapy or device within 30
- •days or within five half-lives, whatever is longer, prior to Screening
- •23. For females, pregnancy or breast-feeding
- 另有 3 项未显示
研究者
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