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: 20.1Level: 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-LV
• 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: 2019-04-04
• Last Update Posted: 12 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 biopsy slides
4. Histological evidence of Stage 2 to 3 liver fibrosis per the NASH CRN System based on central reading of the 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
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 > 8 x upper limit of normal (ULN) at Screening
10. ALT > 8 x ULN 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 (subjects with hyperbilirubinemia associated with documented Gilbert’s syndrome may be eligible upon review by the medical monitor)
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 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, or treated stage II or lower colorectal or breast cancer in remission for = 2 years and with low risk of recurrence (ie, Oncotype DX 12 gene recurrence score <30 for stage II or lower colon cancer; early-stage, estrogen-receptor-positive, HER2-negative breast cancers that haven´t 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 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 (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) inhibitor, or a thiazolidinedione (TZD) for less than 6 months of stable therapy prior to the liver biopsy at Screening
25. Receiving ongoing therapy with any disallowed medication between Screening and Baseline visits.
26. Allergy to the study drug or its components
27. Receiving any investigational products within 30 days prior to Screening or anticipated use during the trial
28. Receiving any investigational product being evaluated for the treatment of liver fibrosis or NASH in the 6 months prior to the Screening liver biopsy (subjects documented to be assigned to placebo in such trials may be eligible immediately following completion of their participation in the previous trial)
29. Participation in any other clinical trial at Screening without approval from the sponsor
30. Any other clinically significant disorders or prior therapy that, in the opinion of the investigator, would make the subject unsuitable for the study or unable to comply with the dosing and protocol requireme

Study & Design

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