Subjects randomized to 1.5 mg OCA will take 1.5 mg OCA daily for 12 weeks. If tolerated, the dose will be increased to 3 mg OCA daily for an additional 12 weeks.

Subjects randomized to 5 mg OCA will take 5 mg OCA daily for 12 weeks. If tolerated, the dose will be increased to 10 mg OCA daily for an additional 12 weeks.

Subjects randomized to placebo will take placebo for 24 weeks.

Subjects randomized to 1.5 mg OCA will take 1.5 mg OCA daily for 12 weeks. If tolerated, the dose will be increased to 3 mg OCA daily for an additional 12 weeks.
OCA

1.5 mg OCA Titrating to 3 mg OCA

Subjects randomized to 5 mg OCA will take 5 mg OCA daily for 12 weeks. If tolerated, the dose will be increased to 10 mg OCA daily for an additional 12 weeks.
OCA

5 mg OCA Titrating to 10 mg OCA

Subjects randomized to placebo will take placebo for 24 weeks.
Placebo

Placebo

Total

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Alkaline phosphatase (ALP)

Total Bilirubin

Weight

Height

The INR is the ratio of a patient's prothrombin time to a normal (control) sample and corrected for the analytical system being used.

International Normalized Ratio (INR)

The primary efficacy analysis will compare the Week 24 change from Baseline in ALP between OCA treatment group and placebo using an analysis of covariance (ANCOVA) model with fixed effects for treatment group and randomization strata, and Baseline as a covariate.

Subjects randomized to placebo will take placebo daily for 24 weeks.
Placebo

Change From Baseline in Serum Alkaline Phosphatase (ALP)

Change From Baseline in Serum Alanine Transaminase (ALT)

Change From Baseline in Serum Aspartate Aminotransferase (AST)

Change From Baseline in Serum Total Bilirubin

Change From Baseline in Serum Direct Bilirubin

Change From Baseline in Serum Gamma-Glutamyl Transferase (GGT)

Change From Baseline in Plasma Fibroblast Growth Factor-19 (FGF-19)

Change From Baseline in Plasma C4

Overall Study

Medical Information

Primary Sclerosing Cholangitis (PSC)

St. Joseph Hospital & Medical Center

Mayo Clinic

UC Davis Medical Center

University of Colorado, Denver

University of Miami

Piedmont Transplant Institute

Gastrointestinal Specialists of Georgia

Rush University Medical Center

University of Chicago

Indiana University School of Medicine

University of Louisville

Tulane Medical Center

Mercy Medical Center

John Hopkins University

Henry Ford Health System

Southern Therapy and Advanced Research

Washington University School of Medicine

St Louis University School of Medicine

Weill Cornell Medicine

Icahn School of Medicine at Mount Sinai

University of Rochester Medical Center

University Hospitals Case Medical Center

The Ohio State University

University of Pennsylvania

University of Pittsburgh

The Liver Institute at Methodist Dallas Medical Center

Texas Baylor University

Baylor College of Medicine

Liver Associates of Texas, P.A.

Texas Digestive Disease Consultants

McGuire DVAMC

Swedish Organ Transplant and Liver Center

Dipartimento di Scienze Mediche e Chirurgiche

Azienda Ospedaliera di Padova - Gastroenterologia

Obeticholic Acid (OCA) in Primary Sclerosing Cholangitis (PSC)

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Finding, Clinical Trial Evaluating the Efficacy and Safety of Obeticholic Acid in Subjects With Primary Sclerosing Cholangitis

Intercept Pharmaceuticals

oxalis macrocarpa

phosphatase

oxalis

oxalis macrocarpa/phosphatase

Obeticholic Acid (OCA) in Primary Sclerosing Cholangitis (PSC)

Најкомплетнија база лековитог биља подржана науком