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Trial record 1 of 1 for:    OBETICHOLIC ACID | Compensated Cirrhosis due to Nonalcoholic Steatohepatitis
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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

February 14, 2018
February 20, 2018
May 24, 2018
August 30, 2017
July 2020   (Final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT03439254 on ClinicalTrials.gov Archive Site
  • Percentage of subjects with improvement in fibrosis by at least 2 stages, using Ishak scoring criteria [ Time Frame: 12 months ]
  • Percentage of subjects with NASH resolution, using the NASH CRN scoring [ Time Frame: 12 months ]
Same as current
Not Provided
Not Provided
 
Study Evaluating the Efficacy and Safety of Obeticholic Acid in Subjects With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis
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
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Compensated Cirrhosis
  • Nonalcoholic Steatohepatitis
  • Drug: Obeticholic acid (10 mg)
    Tablets administered orally once daily.
    Other Names:
    • OCA
    • 6alpha-ethylchenodeoxycholic acid (6-ECDCA)
    • INT-747
  • Drug: Obeticholic acid (10 mg to 25 mg)
    Tablets administered orally once daily.
    Other Names:
    • OCA
    • 6alpha-ethylchenodeoxycholic acid (6-ECDCA)
    • INT-747
  • Drug: Placebo
    Tablets administered orally once daily.
  • Experimental: Obeticholic Acid (OCA) 10 mg
    10 mg OCA for up to 12 months
    Intervention: Drug: Obeticholic acid (10 mg)
  • 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
    Intervention: Drug: Obeticholic acid (10 mg to 25 mg)
  • Placebo Comparator: Placebo
    Placebo for up to 12 months
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
540
Same as current
July 2021
July 2020   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact: Roger Davies 1-619-541-7249 roger.davies@interceptpharma.com
Contact: Carol Parish +44-203-872-5027 carol.parish@interceptpharma.com
United States
 
 
NCT03439254
747-304
Yes
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Intercept Pharmaceuticals
Intercept Pharmaceuticals
Not Provided
Study Director: Christian Weyer, MD Intercept Pharmaceuticals
Intercept Pharmaceuticals
May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP