Safety and Tolerability of Cilofexor in Participants With Primary Sclerosing Cholangitis (PSC) and Compensated Cirrhosis

A Proof-of-Concept, Open-Label Study Evaluating the Safety and Tolerability of Cilofexor in Subjects With Primary Sclerosing Cholangitis (PSC) and Compensated Cirrhosis

Sponsoren

Hauptsponsor: Gilead Sciences

Quelle Gilead Sciences
Kurze Zusammenfassung

The primary objective of this study is to assess the safety and tolerability of escalating doses of cilofexor in participants with primary sclerosing cholangitis (PSC) and compensated cirrhosis.

Gesamtstatus Recruiting
Anfangsdatum October 17, 2019
Fertigstellungstermin June 2021
Primäres Abschlussdatum June 2021
Phase Phase 1
Studientyp Interventional
Primärer Ausgang
Messen Zeitfenster
Percentage of Participants Experiencing Treatment-Emergent Adverse Events First dose date up to Week 12 plus 30 days
Percentage of Participants Experiencing Laboratory Abnormalities First dose date up to Week 12 plus 30 days
Einschreibung 20
Bedingung
Intervention

Interventionsart: Drug

Interventionsname: CILO

Beschreibung: Tablets administered orally once daily

Armgruppenetikett: CILO 30 mg

Teilnahmeberechtigung

Kriterien:

Inclusion Criteria:

- Diagnosis of large duct PSC based on cholangiogram (magnetic resonance cholangiopancreatography [MRCP], endoscopic retrograde cholangiopancreatography [ERCP], or percutaneous transhepatic cholangiogram [PTC])

- Individuals have evidence of cirrhosis based on historical liver biopsy, abdominal imaging (MRI, CT, or Ultrasound), or a screening FibroScan®, ELF™, or FibroTest®.

- Individual has the following laboratory parameters at the Screening visit, as determined by the central laboratory:

- Estimated glomerular filtration rate (eGFR) > 60 mL/min, as calculated by the Cockcroft-Gault equation

- ALT ≤ 5 x ULN

- Total Bilirubin ≤ 1.5 x ULN, except in confirmed cases of Gilbert's syndrome

- INR ≤ 1.4, unless due to therapeutic anticoagulation

- Platelet count ≥ 100,000/μL

- Negative anti-mitochondrial antibody

Exclusion Criteria:

- Current or prior history of any of the following

- Decompensated liver disease, including ascites, hepatic encephalopathy (HE), or variceal hemorrhage

- Liver transplantation

- Cholangiocarcinoma or hepatocellular carcinoma (HCC).

- Model for End-stage Liver Disease (MELD) score > 12 at Screening, unless due to an alternate etiology such as therapeutic anticoagulation

- Child-Pugh (CP) score > 6 at Screening, unless due to an alternative etiology such as Gilbert's syndrome or therapeutic anticoagulation

- Current moderate to severely active inflammatory bowel disease (IBD) in the opinion of the investigator

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Geschlecht: All

Mindestalter: 18 Years

Maximales Alter: 75 Years

Gesunde Freiwillige: No

Insgesamt offiziell
Nachname Rolle Zugehörigkeit
Gilead Study Director Study Director Gilead Sciences
Gesamtkontakt

Nachname: Gilead Clinical Study Information Center

Telefon: 1-833-445-3230

Telefon ext.: GILEAD-0

Email: [email protected]

Ort
Einrichtung: Status:
Arizona Liver Health | Chandler, Arizona, 85224, United States Recruiting
California Liver Research Institute | Pasadena, California, 91105, United States Recruiting
Schiff Center for Liver Diseases/University of Miami | Miami, Florida, 33136, United States Recruiting
Piedmont Atlanta Hospital | Atlanta, Georgia, 30309, United States Recruiting
Louisiana Research Center, LLC | Shreveport, Louisiana, 71105, United States Recruiting
Minnesota Gastroenterology, PA | Maplewood, Minnesota, 55117, United States Recruiting
Northwell Health Center for Liver Diseases and Transplantation | Manhasset, New York, 11030, United States Recruiting
The Liver Institute at Methodist Dallas Medical Center | Dallas, Texas, 75203, United States Recruiting
University of Virginia Medical Center | Charlottesville, Virginia, 22908, United States Recruiting
Bon Secours Richmond Community Hospital, Inc. d/b/a Bon Secours Liver Institute of Richmond | Richmond, Virginia, 23226, United States Recruiting
VCU Clinical Research Services Unit (CRSU) [Patient Site Address] | Richmond, Virginia, 23298, United States Recruiting
University of Washington at Harborview Medical Center | Seattle, Washington, 98104, United States Recruiting
Standort Länder

United States

Überprüfungsdatum

July 2020

Verantwortliche Partei

Art: Sponsor

Hat den Zugriff erweitert No
Bedingung Durchsuchen
Anzahl der Waffen 1
Armgruppe

Etikette: CILO 30 mg

Art: Experimental

Beschreibung: Participants will receive escalating doses of CILO 30 mg, 60 mg, and 100 mg.

Patientendaten No
Studiendesign Info

Zuweisung: N/A

Interventionsmodell: Single Group Assignment

Hauptzweck: Treatment

Maskierung: None (Open Label)

Quelle: ClinicalTrials.gov