Safety, Tolerability, and Efficacy of a Combination Treatment of Tropifexor (LJN452) and Cenicriviroc (CVC) in Adult Patients With Nonalcoholic Steatohepatitis (NASH) and Liver Fibrosis. (TANDEM)



Status:Recruiting
Conditions:Gastrointestinal, Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - Any
Updated:1/11/2019
Start Date:September 11, 2018
End Date:July 27, 2020
Contact:Novartis Pharmaceuticals
Email:novartis.email@novartis.com
Phone:1-888-669-6682

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

A Randomized, Double-blind, Multicenter Study to Assess the Safety, Tolerability, and Efficacy of a Combination Treatment of Tropifexor (LJN452) and Cenicriviroc (CVC) in Adult Patients With Nonalcoholic Steatohepatitis (NASH) and Liver Fibrosis

The purpose of this study is to assess the safety, tolerability, and efficacy of a
combination treatment of tropifexor (LJN452) and cenicriviroc (CVC) in adult patients with
nonalcoholic steatohepatitis (NASH) and liver fibrosis.


Inclusion Criteria:

Written informed consent Male and female patients 18 years or older (at the time of the
screening visit). Patients must weigh at least 50 kg (110 lb) and no more than 200 kg (440
lb) to participate in the study.

Able to communicate well with the investigator, to understand and comply with the
requirements of the study.

Adequate liver biopsy sample for evaluation by Central Reader. Presence of NASH as
demonstrated by histologic evidence based on liver biopsy - NASH with fibrosis stage F2/F3,
demonstrated on liver biopsy during the screening period. Alternatively, a historical
biopsy can be used if performed within 6 months prior to screening.

Exclusion Criteria:

Use of other investigational drugs within 5 half-lives of enrollment or within 30 days
whichever is longer.

History of hypersensitivity to any of the study drugs or its excipients or to drugs of
similar chemical classes.

Previous exposure to elafibranor, CVC, tropifexor, obeticholic acid (OCA), LMB763 or other
FXR agonist.

Participated in a clinical trial and treated with any investigational product being
evaluated for the treatment of liver fibrosis or NASH in the 6 months before screening.

Patients taking medications prohibited by the protocol. History of treated or untreated
malignancy of any organ system, other than localized basal cell carcinoma of the skin or
treated cervical intraepithelial neoplasia, within the past 5 years, regardless of whether
there is evidence of local recurrence or metastases .

Pregnant or nursing (lactating) women. Women of child-bearing potential. Current or history
of significant alcohol consumption for a period of more than 3 consecutive months within 1
year prior to screening (significant alcohol consumption is defined as more than 20 g/day
in females and more than 30 g/day in males, on average) and/or a score on the modified
AUDIT questionnaire ≥ 8.

Inability to reliably quantify alcohol consumption. History or evidence of ongoing drug
abuse, within the last 6 months prior to randomization.

Prior or planned (during the study) bariatric surgery. Uncontrolled diabetes defined as
HbA1c ≥ 9% at screening Clinical evidence of hepatic decompensation or severe liver
impairment. Previous diagnosis of other forms of chronic liver disease. Calculated eGFR
less than 60 mL/min (using the MDRD formula). History of biliary diversion History of liver
transplantation or planned liver transplant. Known positivity for HIV. History or current
diagnosis of ECG abnormalities indicating significant risk of safety for the patient to
participate.

History of inflammatory bowel disease. Patients who are not candidates for liver biopsy.
Presence of cirrhosis on liver biopsy (F4 by NASH CRN System) or medical history Patients
with an abnormal platelet count (referring to reference ranges from the central lab).
We found this trial at
13
sites
Metairie, Louisiana 70006
?
mi
from
Metairie, LA
Click here to add this to my saved trials
Asheville, North Carolina 28803
?
mi
from
Asheville, NC
Click here to add this to my saved trials
Atlanta, Georgia 30322
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
Chandler, Arizona 85224
?
mi
from
Chandler, AZ
Click here to add this to my saved trials
Chattanooga, Tennessee 37404
?
mi
from
Chattanooga, TN
Click here to add this to my saved trials
Dallas, Texas 75216
?
mi
from
Dallas, TX
Click here to add this to my saved trials
?
mi
from
Edegem,
Click here to add this to my saved trials
Germantown, Tennessee 38138
?
mi
from
Germantown, TN
Click here to add this to my saved trials
Indianapolis, Indiana 46202
?
mi
from
Indianapolis, IN
Click here to add this to my saved trials
Morehead City, North Carolina 28557
?
mi
from
Morehead City, NC
Click here to add this to my saved trials
Palmetto Bay, Florida 33157
?
mi
from
Palmetto Bay, FL
Click here to add this to my saved trials
Shreveport, Louisiana 71101
?
mi
from
Shreveport, LA
Click here to add this to my saved trials
Winston-Salem, North Carolina 27157
?
mi
from
Winston-Salem, NC
Click here to add this to my saved trials