| CTRI Number |
CTRI/2023/03/050213 [Registered on: 01/03/2023] Trial Registered Prospectively |
| Last Modified On: |
28/02/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Saroglitazar vs obeticholic acid in patients of fatty liver. |
|
Scientific Title of Study
|
A prospective single centre observational study to evaluate effectiveness and safety of Saroglitazar 4mg Vs Obeticholic acid 10 mg in pateints with non alcoholic fatty liver disease ( NAFLD)/ Non alcoholic Steatohepatitis (NASH). |
| Trial Acronym |
OCASAR in NAFLD/ NASH |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Prof GM Gulzar |
| Designation |
Professor , department of gastroenterology SKIMS |
| Affiliation |
Skims Srinagar |
| Address |
Skims Soura , department of gastroenterology
190011
Skims Soura , department of gastroenterology
190011
Srinagar
JAMMU & KASHMIR
190011
India |
| Phone |
9149615104 |
| Fax |
|
| Email |
gmgulzar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prof GM Gulzar |
| Designation |
Professor , department of gastroenterology SKIMS |
| Affiliation |
Skims Srinagar |
| Address |
Skims Soura , department of gastroenterology
190011
Skims Soura , department of gastroenterology
190011
Srinagar
JAMMU & KASHMIR
190011
India |
| Phone |
9149615104 |
| Fax |
|
| Email |
gmgulzar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prof GM Gulzar |
| Designation |
Professor , department of gastroenterology SKIMS |
| Affiliation |
Skims Srinagar |
| Address |
Skims Soura , department of gastroenterology
190011
Skims Soura , department of gastroenterology
190011
Srinagar
JAMMU & KASHMIR
190011
India |
| Phone |
9149615104 |
| Fax |
|
| Email |
gmgulzar@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Department of Medical gastroenterology |
| Address |
department of medical gastroenterology,
2nd floor, near SICU
Shere -I - Kashmir institute of medical sciences
Srinagar
190011
Contact number 9599618233
Dr ( prof ) GM Gulzar
Dr kalpana Acharya
Srinagar 190011
India |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Kalpana Acharya |
Shere I Kashmir institute srinagar |
Shere Kashmir institute medical sciences
Department of gastroenterology.
2nd floor near SICU
Srinagar
JAMMU & KASHMIR |
9599618233
acharyaacms@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SKIMS IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K740||Hepatic fibrosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Drug |
Arm B. : Saroglitazar 4 mg once a day in pateints of NAFLD/NASH |
| Comparator Agent |
Drug |
Arm A : Obeticholic acid 10 mg Once a day .
Arm B : Saroglitazar 4 mg once a day. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Adults (age 18 to 60) being managed or treated for NAFLD.
•The patient must qualify for NAFLD, according to the American Association for the Study of Liver Diseases (AASLD) criteria (Chalasani et al.2017).
•(a) There is hepatic steatosis by imaging or histology,
•(b) There is no significant alcohol consumption,
•(c) There are no competing aetiologies for hepatic steatosis
•(d) There are no co-existing causes for chronic liver disease.
•Patient’s demonstration of understanding of study requirements and treatment procedures, willingness to comply with all protocol-required evaluations.
•The subjects underwent Fibroscan per the protocol described prior to enrolment and subsequently, they were contacted to participate in the follow-up study at 24 .
•The lipid profile range in the inclusion criteria. TG ≥ 150mg/dl and LDL ≥ 100mg /dL and HDL ≤ 40 mg /dL. |
|
| ExclusionCriteria |
| Details |
Presence of regular or excessive use of alcohol within 2 years prior to initial screening.
Presence of alternative causes of fatty liver, including:
History of bowel surgery, gastrointestinal (bariatric) surgery or undergoing evaluation for bariatric surgery for obesity, extensive small-bowel resection, or orthotopic liver transplants (OLT)
History of other chronic liver disease (Viral hepatitis B or C, autoimmune hepatitis, cholestatic and metabolic liver diseases) and hemochromatosis |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary Endpoints
1.Change in liver fat content by non-invasively measuring CAP parameters through Fibroscan at week 8 16week 24 weeks
2.Change in hepatic fibrosis assessed by non-invasively measuring LSM parameters through Fibroscan at baseline ,week 8, 16 and 24
3.To assess the change in non-invasive scoring methods like NAFLD fibrosis score, FIB 4 Score, BARD Score and FAST Score at baseline, 16 and 24 weeks
4.Compare the overall treatment efficacy in patients with NAFLD/ NASH treated with Saroglitazar magnesium 4mg and OCA 10mg. |
6months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Secondary Endpoints
1.To assess the change in serum alanine aminotransferase (ALT) & aspartate aminotransferase (AST) level from baseline.
2.To assess the change in Lipid profile, the serum triglycerides (TG) level, high-density lipoprotein (HDL), low density lipoprotein (LDL) from baseline.
To assess the change in fasting plasma glucose (FPG)/glycosylated haemoglobin (HbA1c), from baseline |
6 months |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
10/03/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="30" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
METHODOLOGY This is a single centre prospective, double arms, randomised observational study to evaluate the safety and efficacy of Saroglitazar 4mg and OCA 10mg in patients with NAFLD/NASH in real life setting. This is a randomized, open-label, single center study. Patients are randomized to two treatment arms. Arm I: Patients receives Saroglitazar 4mg once daily and moderate physical activity of 30 minutes 5 dyas a week. Arm II: Patients receives OCA 10 mg once daily and moderate physical activity of 30 minutes 5 days a week. Patients are randomized in 1:1 ratio in both the arms and the planned sample size of 100 (50 each arm) subjects, considering 30-35% dropouts by end of the trial. Diet and Exercise- All patients must maintain lifestyle modifications, including diet and exercise as advised by physician for the duration of the study. Patients should make no major changes in the type or amount of exercise in which they partake during the study. Baseline Investigations 1. Hemogram. i. Hemoglobin. ii. Platelet count. iii. WBC (White blood cell) count. iv. Differential WBC count. 2. Liver Function Tests. i. AST (Aspartate aminotransferase). ii. ALT (Alanine aminotransferase). iii. ALP (Alkaline phosphatase). iv. Bilirubin. v. Total protein. vi. Albumin. 3. Fasting 4. Lipid profile Blood Sugar / HbA1c. i. Total cholesterol. ii. HDL (High density lipoprotein) cholesterol. iii. Direct LDL (Low density lipoprotein) cholesterol iv. TG (Triglycerides). 5. Hepatic steatosis measured by CAP score 6. Hepatic Fibrosis measured by LSM 7. Height and Weight 8. Pregnancy Test Follow up Investigations [At week 24 & 52]  Patients will be clinically examined. Safety and efficacy parameters will be assessed as given below. 1. ALT 2. AST 3. Albumin 4. Platelet Count 5. Fasting Blood Sugar. 6. Lipid profile i. HDL (High density lipoprotein) cholesterol. ii. Direct LDL (Low density lipoprotein) cholesterol iii. TG (Triglycerides). 7. Hepatic steatosis measured by CAP score 8. Hepatic Fibrosis measured by LSM 9. Weight 10. Any Significant side effect associated with drug
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