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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)

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 : Active, not recruiting
First Posted : February 20, 2018
Last Update Posted : May 22, 2020
Sponsor:
Information provided by (Responsible Party):
Intercept Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE February 14, 2018
First Posted Date  ICMJE February 20, 2018
Last Update Posted Date May 22, 2020
Actual Study Start Date  ICMJE August 30, 2017
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 12, 2019)
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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: February 19, 2018)
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 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 12, 2019)
  • Percentage of subjects with improvement in fibrosis by at least 2 stages, using Ishak scoring criteria [ Time Frame: 18 months ]
  • Percentage of subjects with NASH resolution, using the NASH CRN scoring [ Time Frame: 18 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: February 19, 2018)
  • 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study Evaluating the Efficacy and Safety of Obeticholic Acid in Subjects With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Compensated Cirrhosis
  • Nonalcoholic Steatohepatitis
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Experimental: Obeticholic Acid (OCA) 10 mg
    10 mg OCA for up to 18 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 15 months of the study
    Intervention: Drug: Obeticholic acid (10 mg to 25 mg)
  • Placebo Comparator: Placebo
    Placebo for up to 18 months
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: February 14, 2020)
919
Original Estimated Enrollment  ICMJE
 (submitted: February 19, 2018)
540
Estimated Study Completion Date  ICMJE June 2022
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Canada,   France,   Germany,   Hungary,   New Zealand,   Poland,   Puerto Rico,   Spain,   Ukraine,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03439254
Other Study ID Numbers  ICMJE 747-304
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Intercept Pharmaceuticals
Study Sponsor  ICMJE Intercept Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Christian Weyer, MD Intercept Pharmaceuticals
PRS Account Intercept Pharmaceuticals
Verification Date May 2020

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