It is a combined treatment of Tropifexor (CLJN452) & Cenicriviroc (CVC) in adult patient having Nonalcoholic fatty liver disease (NAFLD)& formation of an abnormal amount of fibrous tissue in Liver for assessing Safety, Tolerability & effectiveness.
- Conditions
- Health Condition 1: K70-K77- Diseases of liver
- Registration Number
- CTRI/2019/01/017014
- Lead Sponsor
- ovartis Healthcare Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
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.
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,9. 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 Uncontrolled diabetes defined as HbA1c >= 9% at screening Clinical evidence of hepatic decompensation or severe liver impairment 15. Previous diagnosis of other forms of chronic liver disease:16. Calculated eGFR less than 60 mL/min (using the MDRD formula) History of biliary diversion History of liver transplantation or planned liver transplant 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 Platelet count < 120 Ã?109/L
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method