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Trial record 1 of 1 for:    NCT03439254
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Study Evaluating the Efficacy and Safety of Obeticholic Acid in Subjects With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis (REVERSE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03439254
Recruitment Status : Completed
First Posted : February 20, 2018
Last Update Posted : October 27, 2022
Sponsor:
Information provided by (Responsible Party):
Intercept Pharmaceuticals

Study Description
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Brief Summary:
The primary objective of this study is to evaluate whether obeticholic acid (OCA; INT-747) can lead to histological improvement in fibrosis with no worsening of NASH in adults with compensated cirrhosis due to NASH.

Condition or disease Intervention/treatment Phase
Compensated Cirrhosis Nonalcoholic Steatohepatitis Drug: Obeticholic acid (10 mg) Drug: Obeticholic acid (10 mg to 25 mg) Drug: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 919 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Obeticholic Acid in Subjects With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis
Actual Study Start Date : August 30, 2017
Actual Primary Completion Date : September 8, 2022
Actual Study Completion Date : September 8, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Obeticholic Acid (OCA) 10 mg
10 mg OCA for up to 18 months
 Drug: Obeticholic acid (10 mg)
Tablets administered orally once daily.
Other Names:
  • OCA
  • 6alpha-ethylchenodeoxycholic acid (6-ECDCA)
  • INT-747
Experimental: Obeticholic Acid (OCA) 10 mg to 25 mg
10 mg OCA for the first 3 months and then may titrate up to 25 mg OCA for the remaining 15 months of the study
 Drug: Obeticholic acid (10 mg to 25 mg)
Tablets administered orally once daily.
Other Names:
  • OCA
  • 6alpha-ethylchenodeoxycholic acid (6-ECDCA)
  • INT-747
Placebo Comparator: Placebo
Placebo for up to 18 months
 Drug: Placebo
Tablets administered orally once daily.


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of subjects with improvement in fibrosis by at least 1 stage with no worsening of NASH, using NASH Clinical Research Network (CRN) scoring system [ Time Frame: 18 months ]

Secondary Outcome Measures :
  1. Percentage of subjects with improvement in fibrosis by at least 2 stages, using Ishak scoring criteria [ Time Frame: 18 months ]
  2. Percentage of subjects with NASH resolution, using the NASH CRN scoring [ Time Frame: 18 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key inclusion criteria:

1. Subjects with a confirmed diagnosis of NASH and a fibrosis score of 4 based upon the NASH CRN scoring system determined by central reading

Key exclusion criteria:

  1. Current or past history of a clinically evident hepatic decompensation event, such as ascites, hepatic encephalopathy (HE), or variceal bleeding
  2. Current or past history of CP score ≥7 points
  3. Model for End-stage Liver Disease (MELD) score > 12
  4. ALT ≥ 5 X ULN
  5. Calculated creatinine clearance <60mL/min using Cockcroft-Gault method
  6. Hemoglobin A1c (HbA1c) ≥ 9.5 %
  7. Evidence of other known forms of 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)
  8. History of liver transplant, or current placement on a liver transplant list
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03439254


Locations
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Sponsors and Collaborators
Intercept Pharmaceuticals
Investigators
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Study Director: Steven Shiff, MD Intercept Pharmaceuticals
More Information
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Responsible Party: Intercept Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03439254    
Other Study ID Numbers: 747-304
First Posted: February 20, 2018    Key Record Dates
Last Update Posted: October 27, 2022
Last Verified: October 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Intercept Pharmaceuticals:
Compensated Cirrhosis
Nonalcoholic Steatohepatitis
Fatty Liver Disease
NASH
Additional relevant MeSH terms:
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Liver Cirrhosis
Fatty Liver
Non-alcoholic Fatty Liver Disease
Fibrosis
Pathologic Processes
 Liver Diseases
Digestive System Diseases
Chenodeoxycholic Acid
Cathartics
Gastrointestinal Agents