Facilitated By

San Antonio Medical Foundation

Stellaris: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study To Evaluate The Efficacy And Safety Of Cenicriviroc For The Treatment Of Liver Fibrosis In Adult Subjects With Nonalcoholic Steatohepatitis

Brooke Army Medical Center

Brooke Army Medical Center (BAMC) at Fort Sam Houston, Texas, is proud to provide safe, quality care to our military service members, their families, veterans and civilian emergency patients as the most robust and productive healthcare organization within the Military Health System (MHS).

Principal Investigator(s)
Email for information
Funded by
Geneva
Research Start Date
Status
Active

This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study of Cenicriviroc (CVC) for the treatment of Stage 2 to 3 liver fibrosis in adult subjects with Non-Alcoholic Steatohepatitis (NASH). The study will be conducted in 2 parts: Part 1 (surrogate endpoint) and Part 2 (clinical outcomes). Part 1: Approximately 1000 subjects will be randomized. Approximately 667 subjects are to receive CVC and approximately 333 subjects are to receive placebo. Subjects who remain in Part 1 at Month 12 will continue to receive the same treatment assignment in Part 2. Part 2: This part will focus on clinical outcomes and will enroll approximately 2000 subjects (of which up to 1000 subjects will have been randomized in Part 1). Approximately 1334 subjects are to receive CVC and approximately 666 subjects are to receive placebo.

Collaborative Project
Clinical Care
Infectious Disease
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