Role of Obeticholic Acid in the Patients of NAFLD With Raised ALT

NCT03836937 | Completed

• 1 other identifier: SirSalimullahMCMH
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

This study will be conducted upon the patients with fatty liver disease. Patients who will be diagnosed as a case of fatty liver disease by ultrasound with raised liver enzyme (ALT) will be primarily selected for the study. A total number of 70 patients will be randomly selected for the study that will also be divided into two groups for the study purpose. The patients will be informed about the details of the study. After getting the detail information those who will give informed written consent will be finally included in the study. One group of patients will be treated by both life style modification and Obeticholic acid. Another group of patients by only life style modification. After 3 months of treatment the two groups will be compared of improvement of fatty liver disease and liver enzyme by improvement of fibroscan with CAP value as well as improvement of ALT value.

Conditions

Non-Alcoholic Fatty Liver Disease

Outcome Measures

Primary Outcomes (14)

• Change in fibroscan score (Kpa) and CAP value (Kpa) which signifies fibrosis and steatosis status respectively.

  Obeticholic acid and life style modification improve fibroscan with CAP results in patients with NAFLD. 1. Change in symptoms after 12 weeks of treatment or life style modification. 2. Change in liver function test, fibroscan values and CAP values after treatment or life style modification.

  For 12 weeks from the date of enrollment of the patient.

• Change in BMI (weight in kg/height in meter square)

  For 12 weeks from the date of enrollment of the patient.

• Change in ALT (U/L)

  For 12 weeks from the date of enrollment of the patient.

• Fasting blood sugar (FBS) (mmol/L)

  For 12 weeks from the date of enrollment of the patient.

• 2 hours after 75 gm glucose (mmol/L)

  For 12 weeks from the date of enrollment of the patient

• Serum bilirubin (mg/dl)

  For 12 weeks from the date of enrollment of the patient

• Aspertate aminotransferase (AST) (U/L)

  For 12 weeks from the date of enrollment of the patient

• Gamma glutamyle transpeptidase (GGT) (U/L)

  For 12 weeks from the date of enrollment of the patient

• Serum albumin (gm/dl)

  For 12 weeks from the date of enrollment of the patient

• Prothrombin time (PT) (sec)

  For 12 weeks from the date of enrollment of the patient

• Total cholesterol (mg/dl)

  For 12 weeks from the date of enrollment of the patient

• Triglyceride (TG) (mg/dl)

  For 12 weeks from the date of enrollment of the patient

• LDL cholesterol (mg/dl)

  For 12 weeks from the date of enrollment of the patient

• HDL cholesterol (mg/dl)

  For 12 weeks from the date of enrollment of the patient

Study Arms (2)

Obeticholic acid

EXPERIMENTAL

Patients diagnosed as NAFLD with raised ALT will be treated with both life style modification and Obeticholic acid. Obeticholic acid will be given as 10 mg twice daily. Life style modification includes moderate exercise that is 30 minutes brisk walking a day with dietary advice to avoid fatty foods and excessive sugar containing diet and intake of at least 3 vegetables per day.

Drug: Obeticholic acid

Lifestyle modification

NO INTERVENTION

Patients diagnosed as NAFLD with raised ALT will be given only life style modification.Life style modification includes moderate exercise that is 30 minutes brisk walking a day with dietary advice to avoid fatty foods and excessive sugar containing diet and intake of at least 3 vegetables per day.

Interventions

Obeticholic acid DRUG

Farnesoid X receptor ligand which is a semi synthetic bile acid analogue

Also known as: Life style modification

Obeticholic acid

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• NAFLD (by USG)
• Raised ALT (\>40 U/L)

You may not qualify if:

• Patient with significant alcohol intake (more than 20 gm/day).
• Patient with history of taking drugs that may cause fatty liver (i.e. tamoxifen, valproic acid, amiodarone, methotrexate, steroid, OCP) or history of taking drugs that have shown benefit in previous NASH pilot studies (i.e. vitamin E, metformin, thiazolidinediones, statin, ARB, fibrates, DPP-4 inhibitor, Omega-3 fatty acid).
• Chronic viral hepatitis (HBV, HCV).
• Pregnancy
• Patient with co-morbid condition (COPD, CKD, CCF etc.)
• Patient with history of recent MI
• Patient with liver failure
• Patient with hypothyroidism

Sponsors & Collaborators

• Sir Salimullah Medical College Mitford Hospital: lead

Study Sites (1)

Department of Hepatology

Dhaka, 1000, Bangladesh

Location

Related Publications (4)

• Neuschwander-Tetri BA, Loomba R, Sanyal AJ, Lavine JE, Van Natta ML, Abdelmalek MF, Chalasani N, Dasarathy S, Diehl AM, Hameed B, Kowdley KV, McCullough A, Terrault N, Clark JM, Tonascia J, Brunt EM, Kleiner DE, Doo E; NASH Clinical Research Network. Farnesoid X nuclear receptor ligand obeticholic acid for non-cirrhotic, non-alcoholic steatohepatitis (FLINT): a multicentre, randomised, placebo-controlled trial. Lancet. 2015 Mar 14;385(9972):956-65. doi: 10.1016/S0140-6736(14)61933-4. Epub 2014 Nov 7.

  PMID: 25468160 BACKGROUND

• Makri E, Cholongitas E, Tziomalos K. Emerging role of obeticholic acid in the management of nonalcoholic fatty liver disease. World J Gastroenterol. 2016 Nov 7;22(41):9039-9043. doi: 10.3748/wjg.v22.i41.9039.

  PMID: 27895393 BACKGROUND

• Promrat K, Kleiner DE, Niemeier HM, Jackvony E, Kearns M, Wands JR, Fava JL, Wing RR. Randomized controlled trial testing the effects of weight loss on nonalcoholic steatohepatitis. Hepatology. 2010 Jan;51(1):121-9. doi: 10.1002/hep.23276.

  PMID: 19827166 BACKGROUND

• Kirk E, Reeds DN, Finck BN, Mayurranjan SM, Patterson BW, Klein S. Dietary fat and carbohydrates differentially alter insulin sensitivity during caloric restriction. Gastroenterology. 2009 May;136(5):1552-60. doi: 10.1053/j.gastro.2009.01.048. Epub 2009 Jan 25.

  PMID: 19208352 BACKGROUND

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

obeticholic acid

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Study Officials

• Md F Karim, MBBS,FCPS,MD

  Sir Salimullah Medical College

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Open label randomized clinical control trial study

Study Record Dates

• First Submitted: January 9, 2019
• First Posted: February 11, 2019
• Study Start: March 5, 2019
• Primary Completion: November 30, 2020
• Study Completion: December 31, 2021
• Last Updated: May 17, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: February'2019-June'2019
• Access Criteria: drfazalkarim@gmail.com

Locations

BA (1)