The study of an investigational drug, Cenicriviroc, for the treatment of liver fibrosis in patients with Nonalcoholic Steatohepatitis (NASH).

Phase 1

• Conditions: iver fibrosis in Subjects with Nonalcoholic Steatohepatitis; MedDRA version: 22.0Level: PTClassification code 10053219Term: Non-alcoholic steatohepatitisSystem Organ Class: 10019805 - Hepatobiliary disorders; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2016-004566-26-BE
• Lead Sponsor: Tobira Therapeutics Inc., a subsidiary of Allergan plc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-03-13
• Last Update Posted: 19 April 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 2000

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 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

Exclusion Criteria

1. Inability to undergo a liver biopsy safely
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 according to the Modification of Diet in Renal Disease (MDRD) equation at Screening
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
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 (including but not limited to Oncotype DX 12 gene recurrence score <30 for stage II or lower colon cancer; early-stage, estrogen-receptor-positive, HER2-negative breast cancers that have not spread to the lymph nodes; Oncotype DX 21 gene recurrence score <18 for early stage 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
23. Current or anticipated treatment with radiation therapy, cytotoxic chemotherapeutic agents and immune-modulating agents (such as
systemic corticosteroids, interleukins, 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 prior to the 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 conduct of the study. Disallowed medication in use prior to
enrollment will be required to be discontinued. For medications that are disallowed due to significant drug interactions with

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified