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AURORA: Phase 3 Study for the Efficacy and Safety of CVC for the Treatment of Liver Fibrosis in Adults With NASH

This study is currently recruiting participants.
See Contacts and Locations
Verified April 2017 by Tobira Therapeutics, Inc.
Sponsor:
Information provided by (Responsible Party):
Tobira Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT03028740
First received: January 13, 2017
Last updated: April 7, 2017
Last verified: April 2017
  Purpose
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.

Condition Intervention Phase
Nonalcoholic Steatohepatitis Drug: Cenicriviroc Drug: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Investigator
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Tobira Therapeutics, Inc.:

Primary Outcome Measures:
  • Superiority of CVC compared to placebo on liver histology at Month 12 relative to the Screening biopsy [ Time Frame: Measurements at Baseline and 12 months ]
    Proportion of subjects with improvement in fibrosis by at least 1 stage (NASH CRN system) AND no worsening of steatohepatitis

  • Superiority of CVC compared to placebo on the composite endpoint of histopathologic progression to cirrhosis, liver-related clinical outcomes, and all-cause mortality [ Time Frame: Time to accrue a pre-specified number of adjudicated events, End of Study, estimated to be 5 years ]

Secondary Outcome Measures:
  • Effect of CVC compared to placebo on liver histology at Month 60 relative to the Screening biopsy for the proportion of subjects with improvement in fibrosis by at least 1 stage AND no worsening of steatohepatitis [ Time Frame: Time to accrue a pre-specified number of adjudicated events, End of Study, estimated to be 5 years ]

Estimated Enrollment: 2000
Actual Study Start Date: April 4, 2017
Estimated Study Completion Date: October 31, 2024
Estimated Primary Completion Date: July 31, 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Drug: Cenicriviroc
150 mg cenicriviroc
Drug: Cenicriviroc
1 tablet QD
Other Name: CVC
Placebo Comparator: Drug: Placebo
Placebo
Drug: Placebo
1 tablet QD

Detailed Description:
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.
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  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.

Exclusion Criteria:

  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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03028740

Contacts
Contact: Clinical Trials Registry Team 1-877-277-8566 IR-CTRegistration@allergan.com

Locations
United States, Alabama
Digestive Health Specialists of the Southeast Recruiting
Dothan, Alabama, United States, 36305
United States, Florida
South Florida Center of Gastroenterology, PA Recruiting
Wellington, Florida, United States, 33414
United States, Oklahoma
Options Health Research Recruiting
Tulsa, Oklahoma, United States, 74104
Puerto Rico
Fundacion de Investigacion De Diego Recruiting
San Juan, Puerto Rico, 00927
Sponsors and Collaborators
Tobira Therapeutics, Inc.
Investigators
Study Director: Star Seyedkazemi, PharmD Allergan
  More Information

Responsible Party: Tobira Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT03028740     History of Changes
Other Study ID Numbers: 3152-301-002
Study First Received: January 13, 2017
Last Updated: April 7, 2017
Individual Participant Data  
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
TAK-652
Fatty Liver
Liver Cirrhosis
Non-alcoholic Fatty Liver Disease
Liver Diseases
Digestive System Diseases
CCR5 Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on June 27, 2017