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临床试验/NCT02308111
NCT02308111终止4 期

A Phase 4, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study Evaluating the Effect of Obeticholic Acid on Clinical Outcomes in Patients With Primary Biliary Cholangitis

Intercept Pharmaceuticals180 个研究点 分布在 2 个国家目标入组 334 人开始时间: 2014年12月26日最近更新:
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适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
终止
发起方
入组人数
334
试验地点
180
主要终点
Time to the First Occurrence of Composite Endpoint
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验相关资讯

研究概览

简要总结

Primary Biliary Cholangitis (PBC) is a serious, life-threatening, bile acid related liver disease of unknown cause. Without treatment, it frequently progresses to liver fibrosis and eventual cirrhosis requiring liver transplantation or resulting in death. The investigational drug, Obeticholic Acid (OCA) is a modified bile acid and FXR agonist that is derived from the primary human bile acid chenodeoxycholic acid. The key mechanisms of action of OCA, including its choleretic, anti-inflammatory, and anti-fibrotic properties, underlie its hepatoprotective effects and result in attenuation of injury and improved liver function in a cholestatic liver disease such as PBC. The study will assess the effect of OCA compared to placebo, combined with stable standard care, on clinical outcomes in PBC participants.

详细描述

This Phase 4, double-blind, randomized, placebo-controlled, multicenter study is being undertaken at up to 170 sites internationally to evaluate the effect of OCA on clinical outcomes in 428 participants with PBC. The study will include a screening period of up to 8 weeks, requiring two clinic visits. Eligible participants will be randomly allocated (1:1) to treatment with either OCA 5 mg or matching placebo tablets, taken orally once daily for the majority of participants; dose and frequency will be modified for participants with cirrhosis and classified as Child-Pugh (CP) B or C. Randomization will be stratified by standard treatment with UDCA (yes/no) and baseline liver function. The treatment period involves clinic visits approximately every 3 months. At the 3 month visit or any study visit thereafter, if study treatment is tolerated, participants' dose should be titrated per protocol in a blinded manner eg for participants who are non-cirrhotic or classified as CP A and randomized to OCA, they should receive the maximum daily dose of 10 mg OCA, those on placebo continue to receive placebo. Subsequently, daily dosage may return to 5 mg if necessary for these participants who are non-cirrhotic or classified as CP A, but should be increased to 10 mg if possible, based on tolerability and clinical judgment. Safety and tolerability will be assessed by monitoring adverse events and vital signs, and blood and urine testing. The study is event driven and total duration will be determined by the time required to accrue approximately 127 primary endpoint events, estimated to be approximately 10 years. Participants are expected to have a minimum follow-up time of approximately 6 years.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —（Adult, Older Adult）
性别
All
接受健康志愿者
否

入选标准

  • •Definite or probable PBC diagnosis (consistent with American Association for the Study of Liver Diseases [AASLD] and the European Association for the Study of the Liver [EASL] practice guidelines; Lindor 2009; EASL 2009), as demonstrated by the presence of ≥2 of the following 3 diagnostic factors:
  • •History of elevated Alkaline phosphatase levels for at least 6 months
  • •Positive antimitochondrial antibody (AMA) titer or if AMA negative or in low titer (<1:80) PBC-specific antibodies (anti-GP210 and/or anti-SP100 and/or antibodies against the major M2 components [PDC-E2, 2-oxo-glutaric acid dehydrogenase complex])
  • •Liver biopsy consistent with PBC
  • •A mean total bilirubin >ULN and ≤5x ULN and/or a mean ALP >3x ULN
  • •Either is not taking UDCA (no UDCA dose in the past 3 months) or has been taking UDCA for at least 12 months with a stable dose for ≥3 months prior to Day 0

排除标准

  • •History or presence of other concomitant liver diseases including:
  • •Hepatitis C virus infection
  • •Active Hepatitis B infection; however, subjects who have seroconverted (hepatitis B surface antigen and hepatitis B e antigen negative) may be included in this study after consultation with the medical monitor
  • •Primary sclerosing cholangitis (PSC)
  • •Alcoholic liver disease
  • •Definite autoimmune liver disease or overlap hepatitis
  • •Nonalcoholic steatohepatitis (NASH)
  • •Gilbert's Syndrome
  • •Presence of clinical complications of PBC or clinically significant hepatic decompensation, including:
  • •History of liver transplant, current placement on a liver transplant list, or current Model of End Stage Liver Disease (MELD) score >
  • •Subjects who are placed on a transplant list despite a relatively early disease stage (for example per regional guidelines) may be eligible as long as they do not meet any of the other exclusion criteria
  • •Cirrhosis with complications, including history (within the past 12 months) or presence of:
  • •Variceal bleed
  • •Uncontrolled ascites
  • •Encephalopathy
  • •Spontaneous bacterial peritonitis
  • •Known or suspected HCC
  • •Prior transjugular intrahepatic portosystemic shunt procedure
  • •Hepatorenal syndrome (type I or II) or screening (Visit 1 or 2) serum creatinine >2 mg/dL (178 μmol/L)
  • •Mean total bilirubin >5x ULN
  • •Subjects who have undergone gastric bypass procedures (gastric lap band is acceptable) or ileal resection or plan to undergo either of these procedures
  • •Other medical conditions that may diminish life expectancy, including known cancers (except carcinomas in situ or other stable, relatively benign conditions)
  • •If female: plans to become pregnant, known pregnancy or a positive urine pregnancy test (confirmed by a positive serum pregnancy test), or lactating
  • •Known history of human immunodeficiency virus infection
  • •Medical conditions that may cause nonhepatic increases in ALP (eg, Paget's disease or fractures within 3 months)
  • •Other clinically significant medical conditions that are not well controlled or for which medication needs are anticipated to change during the study
  • •History of alcohol abuse or other substance abuse within 1 year prior to Day 0
  • •Participation in another investigational product, biologic, or medical device study within 30 days prior to Screening. Participation in a previous study of OCA is allowed with 3 months washout prior to enrollment in this study
  • •Mental instability or incompetence, such that the validity of informed consent or ability to be compliant with the study is uncertain
  • •History of known or suspected clinically significant hypersensitivity to OCA or any of its components
  • •UDCA naïve (unless contraindicated)

研究组 & 干预措施

Obeticholic Acid (OCA) 5 mg to 10 mg

Experimental

Obeticholic Acid (OCA) 5 mg for a minimum 3 months and then titrating up to a maximum 10 mg for the remainder of the trial (based on tolerability and CP Score).

干预措施: Obeticholic Acid (OCA) (Drug)

Placebo

Placebo Comparator

干预措施: Placebo (Drug)

结局指标

主要结局

Time to the First Occurrence of Composite Endpoint

时间窗: Time to first occurrence from date of randomization until the time to accrue approximately 127 primary endpoint events (up to 7 years)

To assess the effect of OCA, compared to placebo in conjunction with the established local standard of care, on clinical outcomes in participants with PBC as measured by time to the first occurrence of any of the following adjudicated events, derived as a composite event endpoint of death, liver transplant, model of end-stage liver disease (MELD) ≥15, uncontrolled ascites, or hospitalization for new onset or recurrence of variceal bleed, hepatic encephalopathy (as defined by a West Haven score of \>=2), or spontaneous bacterial peritonitis. The clinical events distribution was estimated using the Kaplan-Meier methodology. Point estimates and 95% confidence intervals (CIs) for the clinical events distribution percentiles (25th and 50th) are provided.

Time to the First Occurrence of Primary Clinical Event (Expanded Endpoint)

时间窗: Time to first occurrence from date of randomization until the time to accrue approximately 127 primary endpoint events (up to 7 years)

Primary clinical outcome event is the first occurrence of the following events: death, liver transplant, MELD score \>=15 (MELD-Na score \>=12 baseline), MELD-Na score \>=15 (MELD-Na score \<12 baseline), hospitalization for new onset or recurrence of variceal bleed, hepatic encephalopathy, spontaneous bacterial peritonitis (confirmed by diagnostic paracentesis), or bacterial empyema, uncontrolled or refractory ascites (requiring large volume paracentesis), portal hypertension syndromes, progression to decompensated liver disease, and progression to clinical evidence of portal hypertension without decompensation (for participants without decompensation or clinical evidence of portal hypertension at baseline). 71 endpoint events were observed in the OCA arm, and 80 were observed in the Placebo arm. The clinical events distribution was estimated using the Kaplan-Meier methodology. Point estimates and 95% CIs for the clinical events distribution percentiles (25th and 50th) are provided.

次要结局

  • PK Population: AUC From 0 to 24 Hours Post-dose (AUC0-24h) Of Participants Who Received 5 mg QD OCA and With CP Score=NC(Month 9)
  • Time To First Occurrence Of Severe Decompensating Events of Expanded Composite Endpoint(Time to first occurrence from date of randomization until the date of first documented progression or date of death from any cause, whichever came first (up to 7 years))
  • Time To Liver Transplant Or Death (All-cause)(Time to first occurrence from date of randomization until the date of first documented liver transplant or date of death from any cause (up to 7 years))
  • Time to First Occurrence of Fatal Event (All-Cause)(Time to first occurrence from date of randomization until the date of death from any cause (up to 7 years))
  • Time to First Occurrence of Liver Transplant(Time to first occurrence from date of randomization until the date of first documented liver transplant or date of death from any cause (up to 5 years))
  • Time to First Occurrence of Hospitalization Due to Hepatic Events(Time to first occurrence from date of randomization until the date of hospitalization, liver transplant or death from any cause, whichever came first (up to 5 years))
  • Change From Baseline To Month 72 Of Cytokeratin-18 (CK-18)(Baseline up to Month 72)
  • Time to First Occurrence of Uncontrolled or Refractory Ascites(Time to first occurrence from date of randomization until the date of first documented uncontrolled or refractory ascites, liver transplant or date of death from any cause, whichever came first (up to 5 years))
  • Time to First Occurrence of MELD Score ≥15(Time to first occurrence from date of randomization until the date of first documented MELD Score ≥15, liver transplant or date of death from any cause, whichever came first (up to 5 years))
  • Time To Development Of Varix/Varices(Time to first occurrence from date of randomization until the date of first documented development of varix/varices, liver transplant or death from any cause, whichever came first (up to 5 years))
  • Time To Liver-Related Death(Time to first occurrence from date of randomization until the date of first liver-related or non-liver- related death, whichever came first (up to 5 years))
  • Time To Liver-Related Death Or Liver Transplant(Time to first occurrence from date of randomization until the date of liver transplant, liver-related death or non-liver-related death from any cause, whichever came first (up to 5 years))
  • Time To Liver-Related Death, Liver Transplant, Or MELD Score ≥15(Time to first occurrence from date of randomization until the date of liver transplant, liver-related death, non-liver-related death from any cause or MELD Score ≥15, whichever came first (up to 5 years))
  • Progression To Cirrhosis (for Noncirrhotic Subjects at Baseline)(Time to first occurrence from date of randomization until the date of cirrhosis, liver transplant or death from any cause, whichever came first (up to 5 years))
  • Time To Occurrence Of Hepatocellular Carcinoma (HCC)(Time to first occurrence from date of randomization until the date of HCC diagnosis, liver transplant or death from any cause, whichever came first (up to 5 years))
  • Change From Baseline To Month 24 Of Total Bilirubin(Baseline up to Month 24)
  • Change From Baseline To Month 24 Of Direct Bilirubin(Baseline up to Month 24)
  • Change From Baseline To Month 72 Of 7α-hydroxy-4-cholesten-3-one (C4)(Baseline up to Month 72)
  • Change From Baseline To Month 24 Of Aspartate Aminotransferase (AST)(Baseline up to Month 24)
  • Change From Baseline To Month 24 Of Alanine Aminotransferase (ALT)(Baseline up to Month 24)
  • Change From Baseline To Month 24 Of Alkaline Phosphatase (ALP)(Baseline up to Month 24)
  • Change From Baseline To Month 24 Of Gamma-glutamyl Transferase (GGT)(Baseline up to Month 24)
  • Change From Baseline To Month 24 Of Albumin(Baseline up to Month 24)
  • Change From Baseline To Month 24 Of INR(Baseline up to Month 24)
  • Change From Baseline To Month 72 Of MELD Score(Baseline up to Month 72)
  • Change From Baseline To Month 72 Of MELD-Na Score(Baseline up to Month 72)
  • Change From Baseline To Month 72 Of CPS(Baseline up to Month 72)
  • Change From Baseline To Month 72 Of Mayo Risk Score (MRS)(Baseline up to Month 72)
  • Change From Baseline To Month 72 Of Immunoglobulin-M (IgM)(Baseline up to Month 72)
  • Change From Baseline To Month 72 Of C-reactive Protein (CRP)(Baseline up to Month 72)
  • Change From Baseline To Month 72 Of Tumor Necrosis Factor-α (TNF-α)(Baseline up to Month 72)
  • Change From Baseline To Month 72 Of Fibroblast Growth Factor-19 (FGF-19)(Baseline up to Month 72)
  • PK Population: Area Under The Concentration-Time Curve (AUC) From 0 to 6 Hours Post-dose (AUC0-6h) Of Participants Who Received 5 mg QD OCA and With CP Score=Non-Cirrhotic (NC)(Month 9)
  • Change From Baseline To Month 72 Of Enhanced Liver Fibrosis (ELF)(Baseline up to Month 72)
  • Change From Baseline To Month 72 Of Liver Stiffness - Transient Elastography(Baseline up to Month 72)
  • Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)(Baseline up to the last IP dose plus 30 days and prior to commercial OCA initiation date (up to 7 years))
  • Pharmacokinetic (PK) Population: Fasting Trough Concentrations Of OCA By Dose Regimen(Months 3, 6, 9, 12, 24, 36, 48, and 60)
  • PK Population: Serial Concentration of OCA By Dose Regimen(Month 9)
  • PK Population: Maximum Observed Concentration (Cmax) Of Participants Who Received 5mg QD OCA and With CP Score=NC(Month 9)
  • PK Population: Time to Cmax (Tmax) Of Participants Who Received 5mg QD OCA and With CP Score=NC(Month 9)
  • PK Population: Metabolite to Parent Ratio of AUC0-6h (MRAUC) Of Participants Who Received 5mg QD OCA and With CP Score=NC(Month 9)
  • PK Population: Metabolite to Parent Ratio of Cmax (MRCmax) Of Participants Who Received 5mg QD OCA and With CP Score=NC(Month 9)
  • PK Population: AUC0-6h Of Participants Who Received 5 mg QD OCA and With CP Score=A(Month 9)
  • PK Population: AUC0-24h Of Participants Who Received 5 mg QD OCA and With CP Score=A(Month 9)
  • PK Population: Cmax Of Participants Who Received 5mg QD OCA and With CP Score=A(Month 9)
  • PK Population: Tmax Of Participants Who Received 5mg QD OCA and With CP Score=A(Month 9)
  • PK Population: Concentration at 24 Hours Post-dose (Ctrough) Of Participants Who Received 5mg QD OCA and With CP Score=A(Month 9)
  • PK Population: MRAUC Of Participants Who Received 5mg QD OCA and With CP Score=A(Month 9)
  • PK Population: MRCmax Of Participants Who Received 5mg QD OCA and With CP Score=A(Month 9)
  • PK Population: Ctrough Of Participants Who Received 5mg QD OCA and With CP Score=B(Month 9)
  • PK Population: AUC0-6h Of Participants Who Received 5 mg QOD OCA and With CP Score=NC(Month 9)
  • PK Population: AUC0-24h Of Participants Who Received 5 mg QOD OCA and With CP Score=NC(Month 9)
  • PK Population: Cmax Of Participants Who Received 5mg QOD OCA and With CP Score=NC(Month 9)
  • PK Population: Tmax Of Participants Who Received 5mg QOD OCA and With CP Score=NC(Month 9)
  • PK Population: AUC0-6h Of Participants Who Received 10 mg QD OCA and With CP Score=NC(Month 9)
  • PK Population: Tmax Of Participants Who Received 10 mg QD OCA and With CP Score=NC(Month 9)
  • PK Population: MRCmax Of Participants Who Received 5 mg QD OCA and With MELD Category=A(Month 9)
  • PK Population: Ctrough Of Participants Who Received 5mg QOD OCA and With CP Score=NC(Month 9)
  • PK Population: Cmax Of Participants Who Received 10 mg QD OCA and With CP Score=NC(Month 9)
  • PK Population: Ctrough Of Participants Who Received 10 mg QD OCA and With CP Score=NC(Month 9)
  • PK Population: MRAUC Of Participants Who Received 10 mg QD OCA and With CP Score=NC(Month 9)
  • PK Population: MRCmax Of Participants Who Received 10 mg QD OCA and With CP Score=NC(Month 9)
  • PK Population: Ctrough Of Participants Who Received 5 mg QD OCA and With MELD Category=A(Month 9)
  • PK Population: MRAUC Of Participants Who Received 5 mg QD OCA and With MELD Category=A(Month 9)
  • PK Population: AUC0-24h Of Participants Who Received 5 mg QD OCA and With MELD Category=B(Month 9)
  • PK Population: Cmax Of Participants Who Received 5 mg QD OCA and With MELD Category=B(Month 9)
  • PK Population: Tmax Of Participants Who Received 5 mg QD OCA and With MELD Category=B(Month 9)
  • PK Population: Ctrough Of Participants Who Received 5 mg QD OCA and With MELD Category=B(Month 9)
  • PK Population: MRAUC Of Participants Who Received 5mg QOD OCA and With CP Score=NC(Month 9)
  • PK Population: MRCmax Of Participants Who Received 5mg QOD OCA and With CP Score=NC(Month 9)
  • PK Population: AUC0-24h Of Participants Who Received 10 mg QD OCA and With CP Score=NC(Month 9)
  • PK Population: AUC0-24h Of Participants Who Received 10 mg QD OCA and With CPS Score=A(Month 9)
  • PK Population: Cmax Of Participants Who Received 10 mg QD OCA and With CP Score=A(Month 9)
  • PK Population: Tmax Of Participants Who Received 10 mg QD OCA and With CPS Score=A(Month 9)
  • PK Population: Ctrough Of Participants Who Received 10 mg QD OCA and With CP Score=A(Month 9)
  • PK Population: MRAUC Of Participants Who Received 10 mg QD OCA and With CP Score=A(Month 9)
  • PK Population: AUC0-6h Of Participants Who Received 10 mg Q2W OCA and With CP Score=B(Month 9)
  • PK Population: Tmax Of Participants Who Received 10 mg Q2W OCA and With CP Score=B(Month 9)
  • PK Population: Ctrough Of Participants Who Received 10 mg Q2W OCA and With CP Score=B(Month 9)
  • PK Population: MRAUC Of Participants Who Received 10 mg Q2W OCA and With CP Score=B(Month 9)
  • PK Population: AUC0-6h Of Participants Who Received 10 mg QD OCA and With CP Score=A(Month 9)
  • PK Population: MRCmax Of Participants Who Received 10 mg QD OCA and With CP Score=A(Month 9)
  • PK Population: AUC0-24h Of Participants Who Received 10 mg Q2W OCA and With CP Score=B(Month 9)
  • PK Population: Cmax Of Participants Who Received 10 mg Q2W OCA and With CP Score=B(Month 9)
  • PK Population: AUC0-6h Of Participants Who Received 10 mg QD OCA and With MELD Category=A(Month 9)
  • PK Population: MRCmax Of Participants Who Received 10 mg Q2W OCA and With CP Score=B(Month 9)
  • PK Population: AUC0-6h Of Participants Who Received 5 mg QD OCA and With MELD Category=A(Month 9)
  • PK Population: Tmax Of Participants Who Received 5 mg QD OCA and With MELD Category=A(Month 9)
  • PK Population: AUC0-6h Of Participants Who Received 5 mg QD OCA and With MELD Category=B(Month 9)
  • PK Population: MRAUC Of Participants Who Received 5 mg QD OCA and With MELD Category=B(Month 9)
  • PK Population: MRCmax Of Participants Who Received 5 mg QD OCA and With MELD Category=B(Month 9)
  • PK Population: AUC0-6h Of Participants Who Received 5 mg QOD OCA and With MELD Category=A(Month 9)
  • PK Population: AUC0-24h Of Participants Who Received 5 mg QOD OCA and With MELD Category=A(Month 9)
  • PK Population: Cmax Of Participants Who Received 5 mg QOD OCA and With MELD Category=A(Month 9)
  • PK Population: Tmax Of Participants Who Received 5 mg QOD OCA and With MELD Category=A(Month 9)
  • PK Population: Ctrough Of Participants Who Received 5 mg QOD OCA and With MELD Category=A(Month 9)
  • PK Population: MRAUC Of Participants Who Received 5 mg QOD OCA and With MELD Category=A(Month 9)
  • PK Population: AUC0-24h Of Participants Who Received 5 mg QD OCA and With MELD Category=A(Month 9)
  • PK Population: Cmax Of Participants Who Received 5 mg QD OCA and With MELD Category=A(Month 9)
  • PK Population: Trough Concentrations Of Cirrhotic Participants Who Received 10 mg QD OCA(Months 6, 9, 12, 24, 36, and 60)
  • PK Population: MRCmax Of Participants Who Received 5 mg QOD OCA and With MELD Category=A(Month 9)
  • PK Population: AUC0-24h Of Participants Who Received 10 mg QD OCA and With MELD Category=A(Month 9)
  • PK Population: Cmax Of Participants Who Received 10 mg QD OCA and With MELD Category=A(Month 9)
  • PK Population: Tmax Of Participants Who Received 10 mg QD OCA and With MELD Category=A(Month 9)
  • PK Population: Ctrough Of Participants Who Received 10 mg QD OCA and With MELD Category=A(Month 9)
  • PK Population: MRAUC Of Participants Who Received 10 mg QD OCA and With MELD Category=A(Month 9)
  • PK Population: MRCmax Of Participants Who Received 10 mg QD OCA and With MELD Category=A(Month 9)
  • PK Population: AUC0-6h Of Participants Who Received 10 mg QD OCA and With MELD Category=B(Month 9)
  • PK Population: AUC0-24h Of Participants Who Received 10 mg QD OCA and With MELD Category=B(Month 9)
  • PK Population: Cmax Of Participants Who Received 10 mg QD OCA and With MELD Category=B(Month 9)
  • PK Population: Tmax Of Participants Who Received 10 mg QD OCA and With MELD Category=B(Month 9)
  • PK Population: Ctrough Of Participants Who Received 10 mg QD OCA and With MELD Category=B(Month 9)
  • PK Population: MRAUC Of Participants Who Received 10 mg QD OCA and With MELD Category=B(Month 9)
  • PK Population: MRCmax Of Participants Who Received 10 mg QD OCA and With MELD Category=B(Month 9)
  • PK Population: AUC0-6h Of Participants Who Received 10 mg Q2W OCA and With MELD Category=B(Month 9)
  • PK Population: AUC0-24h Of Participants Who Received 10 mg Q2W OCA and With MELD Category=B(Month 9)
  • PK Population: Cmax Of Participants Who Received 10 mg Q2W OCA and With MELD Category=B(Month 9)
  • PK Population: Tmax Of Participants Who Received 10 mg Q2W OCA and With MELD Category=B(Month 9)
  • PK Population: Ctrough Of Participants Who Received 10 mg Q2W OCA and With MELD Category=B(Month 9)
  • PK Population: MRAUC Of Participants Who Received 10 mg Q2W OCA and With MELD Category=B(Month 9)
  • PK Population: MRCmax Of Participants Who Received 10 mg Q2W OCA and With MELD Category=B(Month 9)
  • PK Population: Trough Concentrations Of Cirrhotic Participants Who Received 5 mg QD OCA(Months 3, 6, 12, 24, and 48)
  • PK Population: Trough Concentrations Of Non-Cirrhotic Participants Who Received 5 mg QD OCA(Months 3, 6, 9, 12, and 24)
  • PK Population: Trough Concentrations Of Cirrhotic Participants Who Received 5 mg QOD OCA(Months 6, 12, and 24)
  • PK Population: Trough Concentrations Of Non-Cirrhotic Participants Who Received 5 mg QOD OCA(Months 3, 6, and 12)
  • PK Population: Trough Concentrations Of Cirrhotic Participants Who Received 5 mg QW OCA(Months 6 and 12)
  • PK Population: Trough Concentrations Of Non-Cirrhotic Participants Who Received 5 mg QW OCA(Month 12)
  • PK Population: Trough Concentrations Of Cirrhotic Participants Who Received 5 mg Q2W OCA(Months 6, 24, 36 and 48)
  • PK Population: Trough Concentrations Of Non-Cirrhotic Participants Who Received 5 mg Q2W OCA(Months 3, 6, 12, 24, 36, and 48)
  • PK Population: Trough Concentrations Of Non-Cirrhotic Participants Who Received 10 mg QD OCA(Months 6, 9, 12, 24, and 36)
  • PK Population: Trough Concentrations Of Cirrhotic Participants Who Received 10 mg QOD OCA(Months 3, 6, 9, 12, 24, 36, 48, and 60)
  • PK Population: Trough Concentrations Of Non-Cirrhotic Participants Who Received 10 mg QOD OCA(Month 12)
  • PK Population: Trough Concentrations Of Cirrhotic Participants Who Received 10 mg Q2W OCA(Month 6)
  • PK Population: Trough Concentrations Of Non-Cirrhotic Participants Who Received 10 mg Q2W OCA(Month 6)

研究者

发起方
Intercept Pharmaceuticals
申办方类型
Industry
责任方
Sponsor

研究点 (180)

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相关资讯

Ocaliva's Conditional Approval for PBC Revoked in Europe After Court Ruling- The European Commission's decision to revoke the conditional marketing authorization for Ocaliva (obeticholic acid) in Europe has been upheld by the General Court of the EU. - Advanz Pharma, which markets Ocaliva in Europe, had its temporary suspension of the revocation lifted, leading to the drug's immediate withdrawal from the EU and EEA markets. - The revocation is based on the EMA's reassessment of Ocaliva's benefit-risk profile, concluding it was no more effective than a placebo for primary biliary cholangitis (PBC). - Ocaliva, a farnesoid X receptor (FXR) agonist, remains available in the US under accelerated approval, while Advanz Pharma considers options for continued patient access in Europe.last yearFDA Rejects Full Approval for Intercept's Ocaliva in Primary Biliary Cholangitis- The FDA issued a complete response letter for Intercept's Ocaliva, preventing its full approval for primary biliary cholangitis (PBC). - The decision aligns with a negative opinion from the Gastrointestinal Drugs Advisory Committee (GIDAC) regarding Ocaliva's clinical benefit. - Ocaliva will remain available in the US under its existing accelerated approval, while the FDA considers post-marketing study data. - This setback follows previous regulatory challenges for Ocaliva, including rejection for NASH and withdrawal of European conditional approval.last year
Phase 4 Study of Obeticholic Acid Evaluating... | 临床试验