Clinical Trials List
2017-05-01 - 2025-12-31
Others
Not yet recruiting9
Recruiting1
Terminated1
ICD-10K75.81
Nonalcoholic steatohepatitis (NASH)
ICD-9571.8
Other chronic nonalcoholic liver disease
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
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Trial Applicant
Syneos Health
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Sponsor
Tobira Therapeutics, Inc.
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Chun-Yen Lin 無
- Chien-Hao Huang 無
- 曾振輝 無
- Yi-Cheng Chen 無
- 鄭雅婷 無
- 陳威廷 無
- 李承翰 無
- I-Shyan Sheen 無
- Wen-Juei Jeng 無
- 滕威 無
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
- Wei-Fan Hsu 無
- Hsueh-Chou Lai 無
- Po-Heng Chuang 無
- 陳昇弘 無
- 蘇文邦 無
- Hung-Wei Wang 無
- Hung-Yao Chen 無
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
- 顏毅豪 Digestive System Department
- Jing-Houng Wang Digestive System Department
- 郭垣宏 Digestive System Department
- 紀廣明 Digestive System Department
- 蔡明釗 Digestive System Department
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
- 葉宏仁 Digestive System Department
- 黃儀倢 Digestive System Department
- 呂宜達 Digestive System Department
- CHUNG-HSIN CHANG Digestive System Department
- TENG-YU LEE Digestive System Department
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
- Pei-Chang Lee 未分科
- Chien-Wei Su Digestive System Department
- 林崇棋 Digestive System Department
- Chi-Jen Chu Digestive System Department
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
Audit
None
Co-Principal Investigator
- Wan-Long Chuang 未分科
Audit
None
Co-Principal Investigator
- 楊宏志 Digestive System Department
- JA-DER LIANG Digestive System Department
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Audit
None
Co-Principal Investigator
- 吳毅晉 無
- Chiu Hung Chiu 無
- Pin-Nan Cheng 無
- 簡世杰 無
- 邱彥程 無
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Audit
None
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
Proportion of subjects with improvement in fibrosis by at least
1 stage (NASH CRN system) AND no worsening of steatohepatitis
(no worsening of lobular inflammation or hepatocellular ballooning
grade) on liver histology at Month 12 relative to the Screening biopsy
Primary Efficacy Endpoint (Part 2):
Time to first occurrence of any of the following adjudicated events
(all subjects):
o Death (all cause)
o Histopathologic progression to cirrhosis
o HCC
o Liver transplant
o MELD score ≥ 15
o Ascites
o Hospitalization (as defined by a stay of ≥ 24 hours) for onset of
variceal bleed, hepatic encephalopathy (defined by a West Haven
Stage of ≥ 2), spontaneous bacterial peritonitis (confirmed by
diagnostic paracentesis)
Each component of this endpoint will be considered by the
independent adjudication committee, and only events confirmed by the
committee will be included in the primary analysis.
If any of the above events occur in Part 1, they will be included in this
primary efficacy endpoint for Part 2.
Inclution Criteria
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 slides
a. Historical biopsy may be substituted for Screening biopsy to
determine eligibility if the following are met:
i. Historical biopsy was obtained no more than 180 days prior
to the first day of screening
ii. Hepatic tissue is available for central histologic evaluation
iii. No new therapeutic intervention for NASH was made during
the 180-day period (e.g., obeticholic acid, vitamin E > 400
IU/day, pioglitazone, rosiglitazone, liraglutide, loss of ≥ 7%
of body weight, bariatric surgery including gastric banding,
investigational NASH agents)
iv. Subjects must have been metabolically stable since the
biopsy (no significant weight loss [≥ 7% of body weight], no
major deterioration of glycemic control, and no introduction
of new or investigational drugs for the treatment of T2DM)
4. Histological evidence of Stage 2 to 3 liver fibrosis per the NASH CRN
System based on central reading of the Screening biopsy slides (refer
to criterion 3a regarding use of a historical biopsy as a substitute for
the Screening biopsy)
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
2. Hepatitis B surface antigen (HBsAg) positive
3. Hepatitis C antibody (HCVAb) positive with the following
2 exceptions:
a. Subjects previously treated for viral hepatitis C with at least a
3-year period since documented sustained virologic response at
Week 12 (post-treatment) may be eligible if all other eligibility
criteria are met
b. Subjects with presence of HCVAb but negative hepatitis C virus
(HCV) ribonucleic acid (RNA) without treatment (i.e.,
spontaneous clearance) may be eligible if all other eligibility
criteria are met
4. Human immunodeficiency virus (HIV)-1 or HIV-2 infection
5. Prior or planned liver transplantation
6. Other known causes of chronic liver disease, such as the following:
a. Alcoholic liver disease
b. Primary biliary cirrhosis
c. Primary sclerosing cholangitis
d. Autoimmune hepatitis
e. Wilson's disease, hemochromatosis, or iron overload
f. Alpha-1-antitrypsin (A1AT) deficiency
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 (one unit of alcohol is half pint of beer
[285 mL; 9.64 oz], 1 glass of spirits [25 mL; 0.85 oz] or 1 glass of
wine [125 mL; 4.23 oz])
9. Aspartate aminotransferase (AST) > 200 IU/L in males and females at
Screening
10. Alanine aminotransferase (ALT) > 250 IU/L in males and > 200 IU/L
in females at Screening
11. Hemoglobin A1c (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)
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, including but not limited to myocardial infarct,
acute coronary syndrome, revascularization (percutaneous coronary
intervention or coronary artery bypass grafting), ischemic stroke, or
implanted defibrillator or pacemaker
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 Screening liver biopsy
(Note: if a historical biopsy is to be used, subjects need to be on stable
therapy for at least 6 months prior to the historical liver biopsy)
25. Receiving ongoing therapy with any disallowed medication between
Screening and Baseline visits. (Note: subjects receiving allowed
concomitant medications need to be on stable therapy for 30 days prior
to the Baseline visit)
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. Participated in a clinical trial with any investigational product being
evaluated for the treatment of liver fibrosis or NASH in the 12 months
before Day 1
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 requirements
The Estimated Number of Participants
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Taiwan
60 participants
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Global
2000 participants
