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Summary

for people ages 18–75 (full criteria)
at San Francisco, California and other locations
study started
estimated completion:

Description

Summary

The AURORA study will be conducted to confirm the efficacy and safety of cenicriviroc (CVC) for the treatment of liver fibrosis in adult subjects with NASH.

Official Title

AURORA: A Phase 3 Study to Evaluate the Efficacy and Safety of Cenicriviroc for the Treatment of Liver Fibrosis in Adult Subjects With Nonalcoholic Steatohepatitis

Details

The AURORA study will be conducted in 2 parts. Part 1 will examine the surrogate endpoint of improvement in fibrosis of at least 1 stage (nonalcoholic steatohepatitis clinical research network [NASH CRN]) and no worsening of steatohepatitis at Month 12. Subjects from Part 1 will continue into Part 2 and additional subjects will be newly randomized in Part 2 to determine long-term clinical outcomes composed of histopathologic progression to cirrhosis, liver-related clinical outcomes, and all-cause mortality.

Keywords

Nonalcoholic Steatohepatitis Fatty Liver Liver Cirrhosis Non-alcoholic Fatty Liver Disease TAK-652

Eligibility

You can join if…

Open to people ages 18–75

  1. Male and female subjects aged between 18-75 years
  2. Ability to understand and sign a written informed consent form (ICF)
  3. Histological evidence of NASH based on central reading of the Screening biopsy
  4. Histological evidence of Stage 2 to 3 liver fibrosis per the NASH CRN System based on central reading of the Screening biopsy slides
  5. Females of childbearing potential and males participating in the study must agree to use at least 2 approved methods of contraception throughout the duration of the study and for 30 days after stopping study drug. Females who are postmenopausal must have documentation of cessation of menses for ≥ 12 months and serum follicle-stimulating hormone (FSH) ≥ 30 mU/mL at Screening.

You CAN'T join if...

  1. Inability to undergo a liver biopsy
  2. Hepatitis B surface antigen (HBsAg) positive
  3. Hepatitis C antibody (HCVAb) positive
  4. Human immunodeficiency virus (HIV)-1 or HIV-2 infection
  5. Prior or planned liver transplantation
  6. Other known causes of chronic liver disease
  7. History or presence of cirrhosis and/or hepatic decompensation including ascites,hepatic encephalopathy or variceal bleeding
  8. Alcohol consumption greater than 21 units/week for males or 14 units/week for females
  9. AST > 200 IU/L in males and females at Screening
  10. . ALT > 250 IU/L in males and > 200 IU/L in females at Screening
  11. . HbA1c > 10% at Screening
  12. . Serum albumin < 3.5 g/dL
  13. . Estimated glomerular filtration rate (eGFR) < 50 mL/min/1.73 m2 according to the Modification of Diet in Renal Disease (MDRD) equation
  14. . Platelet count < 100,000/mm3
  15. . Total bilirubin > 1.5 mg/dL
  16. . International normalized ratio (INR) > 1.3
  17. . Model of end stage liver disease (MELD) score > 12
  18. . Weight reduction through bariatric surgery in the past 5 years or planned during the conduct of the study (including gastric banding)
  19. . History of malignancy within the past 5 years or ongoing malignancy other than basal cell carcinoma, or resected noninvasive cutaneous squamous cell carcinoma
  20. . Active, serious infections that require parenteral antibiotic or antifungal therapy within 30 days prior to Screening Visit
  21. . Clinically significant cardiovascular or cerebrovascular disease within the past 3 months
  22. . Females who are pregnant or breastfeeding
  23. . Current or anticipated treatment with radiation therapy, cytotoxic chemotherapeutic agents and immunomodulating agents
  24. . Receiving a glucagon-like peptide 1 (GLP-1) receptor agonist, a dipeptidyl peptidase 4(DPP-4) inhibitor, a sodium-glucose cotransporter 2 (SGLT2) inhibitor, or a thiazolidinedione (TZD) for less than 6 months of stable therapy prior to the Screening liver biopsy

Locations

  • UCSF School of Medicine accepting new patients
    San Francisco, California, 94143-0538, United States
  • Fresno Clinical Research Center accepting new patients
    Fresno, California, 93720, United States
  • Stanford School of Medicine, Center for Clinical Sciences Research in progress, not accepting new patients
    Palo Alto, California, 94304, United States
  • Franco Felizarta MD accepting new patients
    Bakersfield, California, 93301, United States
  • AV Pediatrics, Allergy and Family Medicine accepting new patients
    Lancaster, California, 93534, United States
  • Island View Gastroenterology Associates accepting new patients
    Ventura, California, 93003, United States
  • Cedars-Sinai Medical Group in progress, not accepting new patients
    Los Angeles, California, 90048, United States
  • GastroIntestinal Biosciences accepting new patients
    Los Angeles, California, 90067-2015, United States
  • Veterans Affairs Greater Los Angeles Healthcare System in progress, not accepting new patients
    Los Angeles, California, 90073, United States
  • Ruane Medical and Liver Health Institute accepting new patients
    Los Angeles, California, 90036, United States
  • Pasadena Liver Center accepting new patients
    Pasadena, California, 91105, United States
  • National Research Institute accepting new patients
    Los Angeles, California, 90057, United States
  • National Research Institute accepting new patients
    Huntington Park, California, 90255, United States
  • Upland Clinical Research accepting new patients
    Upland, California, 91786, United States
  • Inland Empire Liver Foundation accepting new patients
    Rialto, California, 92377-4697, United States
  • eStudySite - Las Vegas accepting new patients
    Las Vegas, Nevada, 89109, United States
  • Southern California Permanente Medical Group accepting new patients
    San Marcos, California, 92069, United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Tobira Therapeutics, Inc.
ID
NCT03028740
Phase
Phase 3
Study Type
Interventional
Last Updated
February 9, 2018
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