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CTRI Number  CTRI/2018/06/014509 [Registered on: 12/06/2018] Trial Registered Prospectively
Last Modified On: 23/08/2018
Post Graduate Thesis   
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study
Modification(s)  
A randomized, double blind, placebo controlled , multicenter, 12 weeks study to assess safety ,tolerability and efficacy of LJN452 in patients with non-alcoholic steatohepatitis 
Scientific Title of Study
Modification(s)  
A randomized, double-blind, placebo controlled, 3- part, adaptive design, multicenter study to assess safety, tolerability and efficacy of tropifexor (LJN452) in patients with non-alcoholic steatohepatitis (NASH) 
Secondary IDs if Any  
Secondary ID  Registry 
CLJN452A2202-NASH  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)  
Name  Murugananthan K  
Address  Novartis Healthcare Private Limited, Medical Department, Sandoz House, Shiv Sagar Estate, Dr. Annie Besant Road, Worli, Mumbai – 400 018 Mumbai MAHARASHTRA Mumbai MAHARASHTRA

Mumbai
MAHARASHTRA
400018
India 
Phone  02224958545  
Fax    
Email  murugananthan.k@novartis.com  
 
Details Contact Person
Scientific Query

Modification(s)  
Name  Murugananthan K  
Address  Novartis Healthcare Private Limited, Medical Department, Sandoz House, Shiv Sagar Estate, Dr. Annie Besant Road, Worli, Mumbai – 400 018 Mumbai MAHARASHTRA Mumbai MAHARASHTRA

Mumbai
MAHARASHTRA
400018
India 
Phone  02224958545  
Fax    
Email  murugananthan.k@novartis.com  
 
Details Contact Person
Public Query

Modification(s)  
Name  Murugananthan K  
Address  Novartis Healthcare Private Limited, Medical Department, Sandoz House, Shiv Sagar Estate, Dr. Annie Besant Road, Worli, Mumbai – 400 018 Mumbai MAHARASHTRA Mumbai MAHARASHTRA

Mumbai
MAHARASHTRA
400018
India 
Phone  02224958545  
Fax    
Email  murugananthan.k@novartis.com  
 
Source of Monetary or Material Support  
Novartis Pharma AG, CH-4002 Basel, Switzerland. 
 
Primary Sponsor  
Name  Novartis Healthcare Pvt Ltd 
Address  Medical Dept, Sandoz House, Shiv Sagar Estate, Dr. Annie Besant Road, Worli, Mumbai- 400018 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     Australia
Austria
Belgium
Canada
France
Germany
India
Italy
Netherlands
Slovakia
Spain
Switzerland
Taiwan
United States of America  
Sites of Study
Modification(s)  
No of Sites = 5  
Contact Person  Name of Site  Site Address  Phone/Fax/Email 
Dr Manav Wadhawan  Fortis Escorts Heart Institute  Fortis Escorts Liver and Digestive Diseases Institute Fortis Escorts Heart Institute Okhla Road New Delhi-110025 India
New Delhi
 
91244713500
91244713500
manavwadhawan@gmail.com 
Dr Shah Samir Ramnik  Global Hospitals-Super Speciality & Transplant Centre  Dr E.Borges Road Hospital Avenue Opp Shirodkar High School Parel Mumbai400012 Maharashtra India
Mumbai
 
912267670101
912267670101
drshahsamir@gmail.com 
Dr Shiv Kumar Sarin  Institute of Liver and Biliary Sciences,   Institute of Liver and Biliary Sciences, Hepatology,D1, Vasant Kunj, Delhi 110070
New Delhi
 
9873173140

shivsarin@gmail.com 
Dr Gaurav Mehta  Kokilaben Dhirubhai Ambani Hospital & Medical research Institute  Rao Saheb Achutrao Patwardhan Marg Four bunglows AndheriWest Mumbai 400 053 Maharshtra India
Mumbai
 
0223099999
02230972030
gaurav.mehta@relianceada.com 
Dr Arvinder Singh Soin  Medanta Institute of Liver Transplantation and Regenerative Medicine  Medanta The Medicity Sector 38 Gurugram 122001 Haryana
Gurgaon
 
911244411441
91244834111
Arvinder.Soin@Medanta.org 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 5  
Name of Committee  Approval Status 
Ethics Committee Global Hospital Mumbai  Submittted/Under Review 
Institution Scientific and Ethics Board Kokilaben Dhirubhai Ambani Hospital & Medical research Institute Rao Saheb Achutrao Patwardhan Marg Four bunglows Andheri West Mumbai 400 053  Approved 
Institutional Ethics Committee Dr Wadhwan  Approved 
Institutional Ethics Committee_Dr Sarin  Approved 
Medanta Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI
Modification(s)  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Non-alcoholic Steatohepatitis NASH 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Arm A LJN452 dose 1   Once daily (morning fasting) treatment with 10 μg LJN452 for 12 weeks 
Intervention  Arm B  Once daily (morning fasting) treatment with 10 μg LJN452 for 12 weeks 
Intervention  Arm C  Once daily (morning fasting) treatment with 10 μg LJN452 for 12 weeks 
Intervention  Arm D  Once daily (morning fasting) treatment with 10 μg LJN452 for 12 weeks 
Intervention  Arm E  Once daily (morning fasting) treatment with 10 μg LJN452 for 12 weeks 
Comparator Agent  Arm F  Once daily (morning fasting) treatment with LJN452 dose A as determined after DMC review of first Part A interim analysis data for 12 weeks 
Comparator Agent  Arm G  Once daily (morning fasting) treatment with LJN452 dose B as determined after DMC review of first Part A interim analysis data for 12 weeks 
Comparator Agent  Arm H  Once daily (morning fasting) treatment with matching placebo for 12 weeks 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1 male/female patients, 18 years or older
2 written informed consent
3 presence of NASH by histological evidence (liver biopsy) and elevated alanine aminotransferase (ALT) OR phenotypic diagnosis based on elevated ALT, BMI and diagnosis of Type 2 diabetes mellitus (DM)
4 Liver fat equal to or higher than 10% by MRI
 
 
ExclusionCriteria 
Details  1 previous exposure to OCA
2 patients taking prohibited medications
3 pregnant or nursing (lactating) women
4 current or history of significant alcohol consumption for a period of more than 3 consecutive months within 1 year prior to screening
5 uncontrolled diabetes mellitus
6 presence of cirrhosis
7 hepatic decompensation or severe liver impairment
8 previous diagnosis of other forms of chronic liver disease
9 patients with contraindications to MRI imaging
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
1 Adverse event profile of different doses of LJN452 in patients with NASH
2 Change in Transaminase levels  
12 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
1 Change from baseline in percentage of fat in the liver assessed using MRI  12 weeks 
2 Change from baseline in weight   12 weeks 
Change from baseline in biomarker C4   12 weeks 
Change from baseline in biomarker FGF19   12 weeks 
Change from baseline in BMI   12 weeks 
Change from baseline in waist-to-hip (WTH) ratio   12 weeks 
Change from baseline on fasting lipid profile   12 weeks 
Change from baseline on gamma-glutamyl transferase (GGT)  12 weeks 
Change from baseline on on markers of liver fibrosis   12 weeks 
Determine C2h of LJN452   12 weeks 
Determine Ctrough of LJN452   12 weeks 
Itch based on a visual analog scale (VAS) rating scale   12 weeks 
 
Target Sample Size   Total Sample Size="250"
Sample Size from India="50" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)
Modification(s)  
14/06/2018 
Date of First Enrollment (Global)  11/01/2018 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Open to Recruitment 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   No publication provided 
Brief Summary  

1 Purpose of the trial

The purpose of this study is to assess the safety and tolerability profile of LJN452 and to determine the early hepatic response to different doses of LJN452 in patien ts with phenotypic non-alcoholic steatohepatitis (NASH). Data from this study will be used to support further development of LJN452 in the treatment of patients with NASH.

2 FPFV for India : 4 Oct 2017

3 Target sample size for India  50

 

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