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Study Evaluating the Efficacy and Safety of Obeticholic Acid in Subjects With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis (REVERSE)

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ClinicalTrials.gov Identifier: NCT03439254
Recruitment Status : Recruiting
First Posted : February 20, 2018
Last Update Posted : May 24, 2018
Sponsor:
Information provided by (Responsible Party):
Intercept Pharmaceuticals

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 540 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
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2021


Arm Intervention/treatment
Experimental: Obeticholic Acid (OCA) 10 mg
10 mg OCA for up to 12 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 9 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 12 months
Drug: Placebo
Tablets administered orally once daily.




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: 12 months ]

Secondary Outcome Measures :
  1. Percentage of subjects with improvement in fibrosis by at least 2 stages, using Ishak scoring criteria [ Time Frame: 12 months ]
  2. Percentage of subjects with NASH resolution, using the NASH CRN scoring [ Time Frame: 12 months ]


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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 hepatic decompensation such as clinically significant 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 ≥ 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

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


Contacts
Contact: Roger Davies 1-619-541-7249 roger.davies@interceptpharma.com
Contact: Carol Parish +44-203-872-5027 carol.parish@interceptpharma.com

  Show 37 Study Locations
Sponsors and Collaborators
Intercept Pharmaceuticals
Investigators
Study Director: Christian Weyer, MD Intercept Pharmaceuticals

Responsible Party: Intercept Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03439254     History of Changes
Other Study ID Numbers: 747-304
First Posted: February 20, 2018    Key Record Dates
Last Update Posted: May 24, 2018
Last Verified: May 2018

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:
Fibrosis
Liver Cirrhosis
Fatty Liver
Non-alcoholic Fatty Liver Disease
Pathologic Processes
Liver Diseases
Digestive System Diseases
Chenodeoxycholic Acid
Cathartics
Gastrointestinal Agents