The study of an investigational drug, Cenicriviroc, for the treatment of liver fibrosis in patients with Nonalcoholic Steatohepatitis (NASH).
- Conditions
- iver fibrosis in Subjects with Nonalcoholic SteatohepatitisMedDRA version: 22.0Level: PTClassification code 10053219Term: Non-alcoholic steatohepatitisSystem Organ Class: 10019805 - Hepatobiliary disordersTherapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Registration Number
- EUCTR2016-004566-26-PL
- Lead Sponsor
- Tobira Therapeutics, Inc., a subsidiary of Allergan plc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 2000
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 liver biopsy slides
4. Subjects included in Part1 must have histopathological evidence of Stage 2 or 3 liver fibrosis per the NASH CRN System based on central reading of the biopsy slides Subjects newly randomized in Part 2 must have histological evidence of Stage 3 liver fibrosis per the NASH CRN System, based on central reading of the Screening period 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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1800
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 200
1. Inability to undergo a liver biopsy safety
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 (NASH CRN Fibrosis Stage 4) 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 > 5 × upper limit of normal (ULN) at Screening
10. ALT > 5 × ULN at Screening
11. HbA1c > 9% at Screening
12. Serum albumin < 3.5 g/dL
13. Estimated glomerular filtration rate (eGFR) < 50 mL/min/1.73 m2 at Screening
according to the Modification of Diet in Renal Disease (MDRD) equation
14. Platelet count < 100,000/mm3 at Screening
15. Total bilirubin > 1.3 mg/dL (subjects with hyperbilirubinemia
associated with documented Gilbert's syndrome may be eligible upon
review by the medical monitor) at Screening
16. International normalized ratio (INR) > 1.3 at Screening
17. Model of end stage liver disease (MELD) score > 12
18. Weight reduction, defined as = 7% of body weight through bariatric surgery in the past 5 years or bariatric surgery
planned during the conduct of the study (including gastric banding and
sleeve surgery)
19. Known history of hepatocellular carcinoma (HCC) at any time, history
of malignancy within the past 5 years or ongoing malignancy other than:
basal cell carcinoma, resected noninvasive cutaneous squamous cell
carcinoma, or treated stage II or lower colorectal or breast cancer in
remission for = 2 years and with documented low risk of recurrence (included but no limited to Oncotype DX
12 gene recurrence score <30 for stage II or lower colon cancer; earlystage,
estrogen-receptor-positive, HER2-negative breast cancers that
have not spread to the lymph nodes; Oncotype DX 21 gene recurrence
score <18 for earlystage invasive breast cancer; or Oncotype DX ductal
carcinoma in situ [DCIS] 12 gene recurrence score <39 for noninvasive
breast cancer)
20. Active, serious infections that require parenteral therapy (antibiotic or
antifungal) 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
chemotherapeutic agents and immunomodulating agents (such as
systemic corticosteroids, interleukins, interferons)
23. Current or anticipated treatment with radiation therapy, cytotoxic
chemotherapeutic agents and immune-modulating agents (such as
systemic corticosteroids, interleukins and interferons)
24. Receiving a glucagon-like peptide 1 (GLP-1) receptor agonist, a
dipeptidyl peptidase 4 (DPP-4) inhibitor, a sodium–glucose
cotransporter 2 (SGLT2) and/or SGLT1 inhibitor, or a thiazolidinedione (TZD) for less
than 6 months of stable therapy prior to the liver biopsy at Screening period liver biopsy (.Subjects on a stable therapy with a GLP-1 receptor agonist, DPP-4 inhibitor, SGLT1 and/or SGLT2 inhibitor, or a TZD for at least 6 months
prior to the Screening liver biopsy may be considered eligible. (Important Note: if a historical biopsy is to be used, subjects need to be
on stable therapy for at least 6 months prior to the day historical liver
biopsy) was performed).
25. Receiving ongoing therapy with any disallowed medication during the
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method