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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02548351
Registration number
NCT02548351
Ethics application status
Date submitted
1/09/2015
Date registered
14/09/2015
Date last updated
17/10/2023
Titles & IDs
Public title
Randomized Global Phase 3 Study to Evaluate the Impact on NASH With Fibrosis of Obeticholic Acid Treatment
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Scientific title
A Phase 3, Double-Blind, Randomized, Long-Term, Placebo-Controlled, Multicenter Study Evaluating the Safety and Efficacy of Obeticholic Acid in Subjects With Nonalcoholic Steatohepatitis
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Secondary ID [1]
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747-303
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Universal Trial Number (UTN)
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Trial acronym
REGENERATE
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Non Alcoholic Steatohepatitis (NASH)
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Condition category
Condition code
Oral and Gastrointestinal
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0
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Metabolic and Endocrine
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0
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Metabolic disorders
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Diet and Nutrition
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0
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Obesity
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Experimental: 10 mg Obeticholic Acid - 10 mg Obeticholic Acid daily for the remainder of the study
Experimental: 25 mg Obeticholic Acid - 25 mg Obeticholic Acid daily for the remainder of the study
Placebo comparator: Placebo - One tablet daily for the remainder of the study
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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To evaluate the effect of Obeticholic Acid compared to placebo on liver histology in non-cirrhotic nonalcoholic steatohepatitis (NASH) subjects with stage 2 or 3 fibrosis by assessing the following primary endpoints
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Assessment method [1]
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Primary endpoints include:
* The proportion of Obeticholic Acid treated patients relative to placebo achieving at least one stage of liver fibrosis improvement with no worsening of NASH, or
* The proportion of Obeticholic Acid treated patients relative to placebo achieving NASH resolution with no worsening of liver fibrosis.
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Timepoint [1]
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Measurements at Baseline and 18 months
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Primary outcome [2]
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To evaluate the effect of Obeticholic Acid compared to placebo on all-cause mortality and liver-related clinical outcomes as measured by the time to first occurrence of any of the listed adjudicated events (clinical outcomes composite endpoint)
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Assessment method [2]
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Primary endpoint events include:
Death (all cause), model of end stage liver disease (MELD) score =15, liver transplant, ascites requiring medical intervention, histological progression to cirrhosis, hospitalization (as defined by a stay of =24 hours) for onset of: variceal bleed, hepatic encephalopathy, spontaneous bacterial peritonitis.
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Timepoint [2]
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Time to accrue a pre-specified number of adjudicated events, End of Study, estimated to be 7 years
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Secondary outcome [1]
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To evaluate the effect of Obeticholic Acid compared to placebo on liver histology in NASH
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Assessment method [1]
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* Improvement of fibrosis by at lease 1 stage AND/OR resolution of NASH, without worsening of either
* No worsening of fibrosis AND no worsening of NASH
* Improvement in each histological feature of NASH by at least 1 point
* Improvement of fibrosis by at least 2 stages
* Improvement in NAS by at least 2 points with no worsening of fibrosis
* Improvement of fibrosis and resolution of NASH as a composite endpoint and as defined by both endpoints being met in the same subject
* Resolution of fibrosis
* Histological progression to cirrhosis
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Timepoint [1]
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18 month Interim Analysis
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Secondary outcome [2]
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To evaluate the effect of Obeticholic Acid compared to placebo on liver histology in NASH
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Assessment method [2]
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* Improvement in fibrosis by at least 1 stage with no worsening of NASH
* NASH resolution with no worsening of fibrosis
* Improvement of fibrosis by at lease 1 stage AND/OR resolution of NASH, without worsening of either
* No worsening of fibrosis AND no worsening of NASH
* Improvement in each histological feature of NASH by at least 1 point
* Improvement of fibrosis by at least 2 stages
* Improvement in NAS by at least 2 points with no worsening of fibrosis
* Improvement of fibrosis and resolution of NASH as a composite endpoint and as defined by both endpoints being met in the same subject
* Resolution of fibrosis
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Timepoint [2]
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End of Study, estimated to be 7 years
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Secondary outcome [3]
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To evaluate the effect of Obeticholic Acid compared to placebo on liver biochemistry and markers of liver function
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Assessment method [3]
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Timepoint [3]
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18 months and End of Study, estimated to be 7 years
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Eligibility
Key inclusion criteria
1. Histologic evidence of NASH upon central read of a liver biopsy obtained no more than 6 months before Day 1 defined by presence of all 3 key histological features of NASH according to NASH CRN criteria.
2. Histologic evidence of fibrosis stage 2 or stage 3 as defined by the NASH CRN scoring of fibrosis, or
Histologic evidence of fibrosis stage 1a or stage 1b if accompanied by =1 of the following risk factors:
* Obesity (BMI =30 kg/m2)
* Type 2 diabetes diagnosed per 2013 American Diabetes Association criteria
* ALT >1.5× upper limit of normal (ULN).
3. For subjects with a historical biopsy, is either not taking or is on stable doses of TZDs/glitazones or vitamin E for 6 months before Day 1.
4. Stable body weight.
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Minimum age
18
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Maximum age
85
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Model for End-stage Liver Disease (MELD) score >12
2. ALT =10× ULN
3. HbA1c >9.5%
4. Total bilirubin >1.5 mg/dL
5. Evidence of other known forms of known chronic liver disease such as alcoholic liver disease, hepatitis B, hepatitis C, PBC, PSC, autoimmune hepatitis, Wilson disease, iron overload, alpha-1-antitrypsin deficiency, drug-induced liver injury, known or suspected hepatocellular carcinoma (HCC)
6. History of liver transplant, or current placement on a liver transplant list
7. Current or history of significant alcohol consumption
8. Prior or planned ileal resection, or prior or planned bariatric surgery
9. Histological presence of cirrhosis
10. History of biliary diversion
11. Known positivity for human immunodeficiency virus infection.
12. Acute cholecystitis or acute biliary obstruction.
13. BMI >45 kg/m2
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Stopped early
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
22/09/2015
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
15/09/2023
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Sample size
Target
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Accrual to date
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Final
2480
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Royal Adelaide Hospital Gastroenterology and Hepatology Dept. - Adelaide
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Flinders Medical Centre - Bedford Park
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AW Morrow Gastroenterology and Liver Centre Royal Prince Alfred Hospital - Camperdown
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Monash Health - Monash Medical Centre - Clayton
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Gallipoli Medical Research Foundation - Greenslopes
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Austin Hospital - Heidelberg
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Royal Brisbane and Women's Hospital - Herston
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Nepean Hospital - Kingswood
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The Alfred Hospital, Department of Gastroenterology - Melbourne
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Fiona Stanley Hospital - Murdoch
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The Royal Melbourne Hospital - Parkville
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Westmead Hospital - Westmead
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5000 - Adelaide
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5042 - Bedford Park
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2050 - Camperdown
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3168 - Clayton
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4120 - Greenslopes
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3084 - Heidelberg
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4029 - Herston
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2747 - Kingswood
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3004 - Melbourne
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6150 - Murdoch
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3053 - Parkville
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2145 - Westmead
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Italy
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Modena
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Italy
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Plymouth
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Funding & Sponsors
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Name
Intercept Pharmaceuticals
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Summary
Brief summary
The primary objectives of this study are to evaluate the effect of Obeticholic Acid treatment compared to placebo on 1) histological improvement and 2) liver-related clinical outcomes in patients with non-cirrhotic nonalcoholic steatohepatitis (NASH) with liver fibrosis.
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Trial website
https://clinicaltrials.gov/study/NCT02548351
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Trial related presentations / publications
Rinella ME, Dufour JF, Anstee QM, Goodman Z, Younossi Z, Harrison SA, Loomba R, Sanyal AJ, Bonacci M, Trylesinski A, Natha M, Shringarpure R, Granston T, Venugopal A, Ratziu V. Non-invasive evaluation of response to obeticholic acid in patients with NASH: Results from the REGENERATE study. J Hepatol. 2022 Mar;76(3):536-548. doi: 10.1016/j.jhep.2021.10.029. Epub 2021 Nov 15. Younossi ZM, Stepanova M, Nader F, Loomba R, Anstee QM, Ratziu V, Harrison S, Sanyal AJ, Schattenberg JM, Barritt AS, Noureddin M, Bonacci M, Cawkwell G, Wong B, Rinella M; RandomizEd Global Phase 3 Study to Evaluate the Impact on NASH with FibRosis of Obeticholic Acid TreatmEnt (REGENERATE) Study Investigators. Obeticholic Acid Impact on Quality of Life in Patients With Nonalcoholic Steatohepatitis: REGENERATE 18-Month Interim Analysis. Clin Gastroenterol Hepatol. 2022 Sep;20(9):2050-2058.e12. doi: 10.1016/j.cgh.2021.07.020. Epub 2021 Jul 15. Younossi ZM, Ratziu V, Loomba R, Rinella M, Anstee QM, Goodman Z, Bedossa P, Geier A, Beckebaum S, Newsome PN, Sheridan D, Sheikh MY, Trotter J, Knapple W, Lawitz E, Abdelmalek MF, Kowdley KV, Montano-Loza AJ, Boursier J, Mathurin P, Bugianesi E, Mazzella G, Olveira A, Cortez-Pinto H, Graupera I, Orr D, Gluud LL, Dufour JF, Shapiro D, Campagna J, Zaru L, MacConell L, Shringarpure R, Harrison S, Sanyal AJ; REGENERATE Study Investigators. Obeticholic acid for the treatment of non-alcoholic steatohepatitis: interim analysis from a multicentre, randomised, placebo-controlled phase 3 trial. Lancet. 2019 Dec 14;394(10215):2184-2196. doi: 10.1016/S0140-6736(19)33041-7. Epub 2019 Dec 5. Erratum In: Lancet. 2020 Aug 1;396(10247):312. doi: 10.1016/S0140-6736(20)31645-7. Lancet. 2021 Jun 19;397(10292):2336. doi: 10.1016/S0140-6736(21)01216-2. Ratziu V, Sanyal AJ, Loomba R, Rinella M, Harrison S, Anstee QM, Goodman Z, Bedossa P, MacConell L, Shringarpure R, Shah A, Younossi Z. REGENERATE: Design of a pivotal, randomised, phase 3 study evaluating the safety and efficacy of obeticholic acid in patients with fibrosis due to nonalcoholic steatohepatitis. Contemp Clin Trials. 2019 Sep;84:105803. doi: 10.1016/j.cct.2019.06.017. Epub 2019 Jun 29.
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Public notes
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Contacts
Principal investigator
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Sangeeta Sawhney, MD
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Intercept Pharmaceuticals
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Contact person for scientific queries
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Results not provided in
https://clinicaltrials.gov/study/NCT02548351
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