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



Status:Recruiting
Conditions:Gastrointestinal, Gastrointestinal, Hepatitis
Therapuetic Areas:Gastroenterology, Immunology / Infectious Diseases
Healthy:No
Age Range:18 - 75
Updated:3/31/2019
Start Date:April 20, 2017
End Date:October 28, 2028
Contact:Clinical Trials Registry Team
Email:IR-CTRegistration@allergan.com
Phone:1-877-277-8566

Use our guide to learn which trials are right for you!

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

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.

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.

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
We found this trial at
175
sites
Tulsa, Oklahoma 74137
158
mi
from
Tulsa, OK
Click here to add this to my saved trials
3400 N Charles St
Baltimore, Maryland 21205
410-516-8000
Johns Hopkins University The Johns Hopkins University opened in 1876, with the inauguration of its...
1148
mi
from
Baltimore, MD
Click here to add this to my saved trials
1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
676
mi
from
Birmingham, AL
Click here to add this to my saved trials
185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
1443
mi
from
Boston, MA
Click here to add this to my saved trials
330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
1444
mi
from
Boston, MA
Click here to add this to my saved trials
1000 Blythe Blvd
Charlotte, North Carolina 28203
(704) 355-2000
957
mi
from
Charlotte, NC
Click here to add this to my saved trials
Durham, North Carolina 27710
(919) 684-8111
Duke University Younger than most other prestigious U.S. research universities, Duke University consistently ranks among...
1052
mi
from
Durham, NC
Click here to add this to my saved trials
1200 Moursund Street
Houston, Texas 77030
(713) 798-4951
Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
569
mi
from
Houston, TX
Click here to add this to my saved trials
2010 Wilshire Boulevard
Los Angeles, California 90057
213-413-2500
1170
mi
from
Los Angeles, CA
Click here to add this to my saved trials
610 3rd St # 206
Macon, Georgia 31201
868
mi
from
Macon, GA
Click here to add this to my saved trials
305 1st Avenue # Dazian 7
New York, New York 10003
(212) 420-2806
Beth Israel Med Ctr The physicians and staff of Mount Sinai Beth Israel's Heart Institute...
1288
mi
from
New York, NY
Click here to add this to my saved trials
1 Gustave L Levy Pl # 271
New York, New York 10029
 (212) 241-6500
Mount Sinai Med Ctr Founded in 1852, The Mount Sinai Hospital is a 1,171-bed, tertiary-care...
1289
mi
from
New York, NY
Click here to add this to my saved trials
201 Presidents Circle
Salt Lake City, Utah 84108
801) 581-7200
University of Utah Research is a major component in the life of the U benefiting...
777
mi
from
Salt Lake City, UT
Click here to add this to my saved trials
7940 Floyd Curl Dr.
San Antonio, Texas 78229
210-949-0122
570
mi
from
San Antonio, TX
Click here to add this to my saved trials
8881 Fletcher Parkway Suite 250
San Diego, California 91942
619-589-6888
1132
mi
from
San Diego, CA
Click here to add this to my saved trials
1 Tampa General Cir
Tampa, Florida 33606
(813) 844-7000
Tampa General Hospital In a diverse city known for its rich culture and beautiful beaches,...
1117
mi
from
Tampa, FL
Click here to add this to my saved trials
40 Sunshine Cottage Road
Valhalla, New York 10595
(914) 594-4000
New York Medical College The College was founded in 1860 by a group of New...
1299
mi
from
Valhalla, NY
Click here to add this to my saved trials
1085 N Harbor Blvd
Anaheim, California 92801
(714) 774-7777
Anaheim Clinical Trials, LLC Anaheim Clinical Trials (ACT) is a research center of excellence for...
1155
mi
from
Anaheim, CA
Click here to add this to my saved trials
95 Collier Road Northwest
Atlanta, Georgia 30309
799
mi
from
Atlanta, GA
Click here to add this to my saved trials
517
mi
from
Austin, TX
Click here to add this to my saved trials
Bakersfield, California 93301
1184
mi
from
Bakersfield, CA
Click here to add this to my saved trials
345 Saint Paul Place
Baltimore, Maryland 21202
1148
mi
from
Baltimore, MD
Click here to add this to my saved trials
Baltimore, Maryland 21209
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
?
mi
from
Bastrop, LA
Click here to add this to my saved trials
8901 Rockville Pike
Bethesda, Maryland 20889
(301) 295-4000
Walter Reed National Military Medical Center The Walter Reed National Military Medical Center is one...
1123
mi
from
Bethesda, MD
Click here to add this to my saved trials
Bethlehem, Pennsylvania 18017
?
mi
from
Bethlehem, PA
Click here to add this to my saved trials
Bridgeport, Connecticut 06606
1330
mi
from
Bridgeport, CT
Click here to add this to my saved trials
506 6th St
Brooklyn, New York 11215
(718) 780-3000
New York Methodist Hospital A voluntary, acute-care teaching hospital, New York Methodist Hospital's mission is...
1287
mi
from
Brooklyn, NY
Click here to add this to my saved trials
1062
mi
from
Buffalo, NY
Click here to add this to my saved trials
Catonsville, Maryland 21228
1142
mi
from
Catonsville, MD
Click here to add this to my saved trials
1955 West Frye Road
Chandler, Arizona 85224
846
mi
from
Chandler, AZ
Click here to add this to my saved trials
Chattanooga, Tennessee 37421
728
mi
from
Chattanooga, TN
Click here to add this to my saved trials
Chevy Chase, Maryland 20815
1124
mi
from
Chevy Chase, MD
Click here to add this to my saved trials
303 East Superior Street
Chicago, Illinois 60611
611
mi
from
Chicago, IL
Click here to add this to my saved trials
1653 W. Congress Parkway
Chicago, Illinois 60612
(312) 942-5000
Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
608
mi
from
Chicago, IL
Click here to add this to my saved trials
Chula Vista, California 91910
1139
mi
from
Chula Vista, CA
Click here to add this to my saved trials
Chula Vista, California 91910
1140
mi
from
Chula Vista, CA
Click here to add this to my saved trials
725
mi
from
Cincinnati, OH
Click here to add this to my saved trials
Ciudad Autonoma de Buenos Aires, Buenos Aires 01181
?
mi
from
Ciudad Autonoma de Buenos Aires,
Click here to add this to my saved trials
Clearwater, Florida 33756
1100
mi
from
Clearwater, FL
Click here to add this to my saved trials
Clive, Iowa 50325
342
mi
from
Clive, IA
Click here to add this to my saved trials
Columbia, Maryland 21045
1136
mi
from
Columbia, MD
Click here to add this to my saved trials
410 W 10th Ave
Columbus, Ohio 43210
(614) 293-8652
The Ohio State University, Wexner Medical Center Located in Columbus, The Ohio State University Wexner...
810
mi
from
Columbus, OH
Click here to add this to my saved trials
370 Minorca Avenue
Coral Gables, Florida 33134
1319
mi
from
Coral Gables, FL
Click here to add this to my saved trials
Coronado, California 92118
1145
mi
from
Coronado, CA
Click here to add this to my saved trials
Cumberland, Rhode Island 02864
1424
mi
from
Cumberland, RI
Click here to add this to my saved trials
350
mi
from
Dallas, TX
Click here to add this to my saved trials
5425 West Spring Creek Parkway
Dallas, Texas 75234
328
mi
from
Dallas, TX
Click here to add this to my saved trials
1801 Inwood Rd
Dallas, Texas 75390
(214) 645-3300
University of Texas Southwestern Medical Center UT Southwestern is an academic medical center, world-renowned for...
349
mi
from
Dallas, TX
Click here to add this to my saved trials
Detroit, Michigan 48202
841
mi
from
Detroit, MI
Click here to add this to my saved trials
Doral, Florida 33166
1313
mi
from
Doral, FL
Click here to add this to my saved trials
834
mi
from
Dothan, AL
Click here to add this to my saved trials
Draper, Utah 84020
775
mi
from
Draper, UT
Click here to add this to my saved trials
Englewood, Colorado 80113
408
mi
from
Englewood, CO
Click here to add this to my saved trials
1114
mi
from
Fairfax, VA
Click here to add this to my saved trials
Falls Church, Virginia 22042
1119
mi
from
Falls Church, VA
Click here to add this to my saved trials
Fayetteville, North Carolina 28304
1063
mi
from
Fayetteville, NC
Click here to add this to my saved trials
2510 Lakeland Drive
Flowood, Mississippi 39232
574
mi
from
Flowood, MS
Click here to add this to my saved trials
Flushing, New York 11355
1296
mi
from
Flushing, NY
Click here to add this to my saved trials
Fort Sam Houston, Texas 78234
574
mi
from
Fort Sam Houston, TX
Click here to add this to my saved trials
1400 8th Avenue
Fort Worth, Texas 76104
347
mi
from
Fort Worth, TX
Click here to add this to my saved trials
?
mi
from
Fort Worth, TX
Click here to add this to my saved trials
7055 North Maple Avenue
Fresno, California 93720
1203
mi
from
Fresno, CA
Click here to add this to my saved trials
1206
mi
from
Fresno, CA
Click here to add this to my saved trials
Germantown, Tennessee 38138
481
mi
from
Germantown, TN
Click here to add this to my saved trials
Grand Junction, Colorado 81505
?
mi
from
Grand Junction, CO
Click here to add this to my saved trials
5653 Frist Boulevard
Hermitage, Tennessee 37076
628
mi
from
Hermitage, TN
Click here to add this to my saved trials
High Point, North Carolina 27265
991
mi
from
High Point, NC
Click here to add this to my saved trials
Houston, Texas 77004
571
mi
from
Houston, TX
Click here to add this to my saved trials
Houston, Texas 77030
572
mi
from
Houston, TX
Click here to add this to my saved trials
569
mi
from
Houston, TX
Click here to add this to my saved trials
569
mi
from
Houston, TX
Click here to add this to my saved trials
Houston, Texas 77062
586
mi
from
Houston, TX
Click here to add this to my saved trials
Houston, Texas 77098
570
mi
from
Houston, TX
Click here to add this to my saved trials
?
mi
from
Huntington, WV
Click here to add this to my saved trials
Huntington Park, California 90255
1169
mi
from
Huntington Park, CA
Click here to add this to my saved trials
643
mi
from
Indianapolis, IN
Click here to add this to my saved trials
Inverness, Florida 34452
1084
mi
from
Inverness, FL
Click here to add this to my saved trials
200 Hawkins Dr,
Iowa City, Iowa 52242
866-452-8507
University of Iowa Hospitals and Clinics University of Iowa Hospitals and Clinics—recognized as one of...
429
mi
from
Iowa City, IA
Click here to add this to my saved trials
4022 Worral Way
Jacksonville, Florida 32224
1068
mi
from
Jacksonville, FL
Click here to add this to my saved trials
Kansas City, Missouri 64218
198
mi
from
Kansas City, MO
Click here to add this to my saved trials
9500 Gilman Dr
La Jolla, California 92093
(858) 534-2230
The University of California, San Diego UC San Diego is an academic powerhouse and economic...
1145
mi
from
La Jolla, CA
Click here to add this to my saved trials
La Mesa, California 91942
1133
mi
from
La Mesa, CA
Click here to add this to my saved trials
Lakewood Ranch, Florida 34211
1140
mi
from
Lakewood Ranch, FL
Click here to add this to my saved trials
Lancaster, California 93534
1149
mi
from
Lancaster, CA
Click here to add this to my saved trials
Las Vegas, Nevada 89109
963
mi
from
Las Vegas, NV
Click here to add this to my saved trials
Las Vegas, Nevada 89113
960
mi
from
Las Vegas, NV
Click here to add this to my saved trials
Little Rock, Arkansas 72205
368
mi
from
Little Rock, AR
Click here to add this to my saved trials
Live Oak, Texas 78233
566
mi
from
Live Oak, TX
Click here to add this to my saved trials
5901 West Olympic Boulevard
Los Angeles, California 90036
1174
mi
from
Los Angeles, CA
Click here to add this to my saved trials
8631 West 3rd Street
Los Angeles, California 90048
1175
mi
from
Los Angeles, CA
Click here to add this to my saved trials
Los Angeles, California 90067
1177
mi
from
Los Angeles, CA
Click here to add this to my saved trials
1168
mi
from
Los Angeles, CA
Click here to add this to my saved trials
Louisville, Kentucky 40202
655
mi
from
Louisville, KY
Click here to add this to my saved trials
?
mi
from
Madison, AL
Click here to add this to my saved trials
Madison, New Jersey 07940
?
mi
from
Madison, NJ
Click here to add this to my saved trials
Maitland, Florida 32751
1138
mi
from
Maitland, FL
Click here to add this to my saved trials
Maplewood, Minnesota 55117
?
mi
from
Maplewood, MN
Click here to add this to my saved trials
Marietta, Georgia 30060
788
mi
from
Marietta, GA
Click here to add this to my saved trials
1101 Medical Center Boulevard
Marrero, Louisiana 70072
700
mi
from
Marrero, LA
Click here to add this to my saved trials
Martinsville, New Jersey 08836
1257
mi
from
Martinsville, NJ
Click here to add this to my saved trials