Subjects with femoral condyle osteochondral defects ≥10mm, as determined by MRI or diagnostic knee arthroscopy, will be recruited for allograft transplantation.

Subjects with femoral condyle osteochondral defects <10mm, as determined by MRI or diagnostic knee arthroscopy, will be recruited for microfracture treatment.

Outcomes of Allograft

University of Missouri-Hospital and Clinics

Long Term Outcomes of Osteochondral Allografts for Osteochondral Defects of the Knee

Long Term Outcomes of Osteochondral Allografts for Osteochondral Defects of the Knee.

Subject outcomes will be assessed through validated outcomes scoring systems, including the International Knee Documentation Committee (IKDC), the SF-36 health survey and the Tegner activity scale. These will be completed by the participants prior to the index procedure and at the 3, 6 and 12 month visits and yearly thereafter.

James Stannard

Professor and Chairman - Orthopaedic Surgery

University of Missouri-Columbia

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 Child Pugh Score).

Liver Cirrhosis, Biliary

Non-cirrhotic and classified as Child-Pugh Class A: 5 mg tablet of OCA once daily titrating up to a maximum of 10 mg OCA once daily based on tolerability at 3 months for the duration of the study (majority of patients).
Cirrhotic and classified as Child-Pugh Class B and C: 5 mg tablet of OCA once weekly for at least 3 months, subsequently titrating up to a maximum dose and frequency of 10 mg OCA twice weekly based on tolerability and biochemical response for the duration of the study.

Obeticholic Acid (OCA)

One tablet daily (or a lower frequency depending on Child Pugh score) for the remainder of the study

Placebo

Mayo Clinic Arizona

Cedars-Sinai Medical Center

Inland Empire Liver Foundation

University of California Davis, Davis Medical Center

Stanford University

University of Colorado Denver and Hospital

UF Hepatology Research at CTRB

Schiff Center for Liver Diseases/University of Miami

Piedmont Atlanta Hospital

Emory University Hospital

Gastrointestinal Specialists of Georgia

Northwestern University Feinberg School of Medicine

University of Chicago Medical Center

Indiana University

Indianapolis Gastroenterology Research Foundation

University of Louisville, Medical Dental Complex

Tulane University Medical Center

Mercy Medical Center

UMass Medical School

Henry Ford Health System

Minnesota Gastroenterology, P.A.

Southern Therapy and Advanced Research (STAR)

Kansas City Research Institute

Saint Louis University Gastroenterology & Hepatology

Saint Joseph's Regional Medical Center

Mount Sinai Beth Israel

Weill Cornell Medical College

University of Rochester Medical Center

Hospital of the University of Pennsylvania

Quality Medical Research, PLLC

The Liver Institute at Methodist Dallas Medical Center

Baylor University Medical Center

Texas Digestive Disease Consultants

UT Southwestern Medical Center

Brooke Army Medical Center

Baylor Scott and White Research Institute

Baylor College of Medicine - Advanced Liver Therapies

UT Health The University of Texas Health Science Center at Houston

American Research Corporation at Texas Liver Institute

Clinical Research Centers of America

McGuire DVAMC

Swedish Organ Transplant & Liver Center

Centro De Hepatología

Hospital Universitario Austral

Dim Clínica Privada

Hospital Privado Universitario de Cordoba S.A.

Hospital Provincial del Centenario

CIPREC - Centro de Investigacion y Prevencion Cardiovascular S.A.

Hospital De Clinicas University Of Buenos Aires

Centrol Integral de Gastroenterologia

Hospital Italiano de Buenos Aires

Hospital de Gastroenterologia Dr. Carlos Bonorino Udaondo

Hospital Aleman

Hospital Britanico De Buenos Aires

AW Morrow Gastroenterology and Liver Centre, Royal Prince Alfred Hospital

Department of Gastroenterology & Hepatology, Nepean Hospital

Gallipoli Medical Research Foundation

Department of Gastroenterology and Hepatology, Royal Adelaide Hospital

Flinders Medical Centre

Box Hill Hospital

St. Vincent's Hospital Melbourne

Austin Hospital

Fiona Stanley Hospital, Gastroenterology Department

AKH, Medical University of Vienna

University Hospital Antwerp

Uz Leuven

Cub Hôpital Erasme

University Hospital Ghent

Hospital Sao Rafael

Gastrocentro/ Universidade Estadual de Campinas (UNICAMP)

Instituto Hospital de Base do Distrito Federal-IHBDF

Instituto Goiano de Gastroenterologia

Cepec Huufma

Hospital das Clinicas da Universidade Federal de Minas Gerais (UFMG)

Hospital de Clinicas de Porto Alegre

Hospital Universitario Professor Edgard Santos

Gastrocentro. Unidad Estadual de CAmpinas UNICAMP

Universidade Federal do Estado do Rio de Janeiro - Hospital Universitario Gaffree e Guinle/HUGG/UNIRIO

Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo-HCFMUSP

St. Ivan Rilsky University Hospital

University of Calgary Liver Unit (Heritage Medical Research Clinic)

University of Alberta, Walter C. Mackenzie Health Sciences Centre (WMC)

University Of Manitoba, Health Sciences Centre

London Health Sciences Centre-University Hospital

University Health Network, Toronto General Hospital

Chum

Centro De Investigaciones Clínicas Viña Del Mar

Aarhus University Hospital Department of Hepatology and Gastroenterology

Medicinsk klinik for mave, tarm-og leversygdomme

Odense University Hospital Afdeling for medicinske mave-tarmsygdomme S

East Tallinn Central Hospital Gastroenterology Center

Tartu University Hospital

Helsinki University Central Hospital

Turku University Central Hospital, Gastroenterology Outpatient Clinic

Hospital Saint-Antoine, A.P.-H.P.

CHRU Hôpital HURIEZ

Chu De Bordeaux - Hôpital Haut Lévêque

Klinikum der Johann-Wolfgang Goethe, Universitaet Frankfurt am Main

Medizinische Hochschule Hannover, Klinik für Gastroenterologie, Hepatologie und Endokrinologie

Phase 4 Study of Obeticholic Acid Evaluating Clinical Outcomes in Patients With Primary Biliary Cholangitis

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

Primary endpoint events include:
death
liver transplant
MELD score ≥15
uncontrolled ascites
hospitalization for new onset or recurrence of any of the following:
variceal bleed
hepatic encephalopathy
spontaneous bacterial peritonitis

Individual events include:
death
liver transplant
MELD score >15
uncontrolled ascites
hospitalization for new onset or recurrence of any of the following:
variceal bleed
hepatic encephalopathy
spontaneous bacterial peritonitis

To assess the effect of OCA compared to placebo on time to occurrence of liver-related death

To assess the effect of OCA compared to placebo on progression to cirrhosis

To assess the effect of OCA compared to placebo on time to occurrence of hepatocellular carcinoma (HCC)

oxalis/priešuždegiminis

Long Term Outcomes of Osteochondral Allografts for Osteochondral Defects of the Knee

Phase 4 Study of Obeticholic Acid Evaluating Clinical Outcomes in Patients With Primary Biliary Cholangitis

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