A study on the efficacy and safety of a new drug (OCA) in patients with non-alcoholic fatty liver hepatitis (NASH).
Résumé de l'étude
The study examines a new treatment option for non-alcoholic steatohepatitis (NASH). There are currently no therapies approved for the treatment of NASH. The sponsor of this study, Intercept Pharmaceuticals, Inc., is investigating the investigational drug Obeticholic acid (also referred to as OCA) and its impact on your condition, NASH. If you are eligible to participate in this study, your treatment phase will begin, during which you will be randomly assigned to the study medication OCA (10 mg or 25 mg) or a placebo. Throughout the duration of the study, which is expected to last up to 7 years, you will take approximately 1 tablet every day at about the same time. Before your appointments, you must not eat or drink for at least 8 hours. At the appointment in month 0 (day 1), you will be randomly assigned by a computer program (i.e., like flipping a coin) to 1 of 3 study treatment groups (10 mg OCA, 25 mg OCA, or placebo). This appointment will be followed 4 weeks later (month 1) by another appointment. After that, you will need to visit the study center every 3 months (month 3, 6, 9, 12, 12, 15) until the appointment in month 18. After you complete the appointment in month 18, you will be asked to appear at the clinic every 6 months until the study is completed.
(BASEC)
Intervention étudiée
The study examines a new treatment option for non-alcoholic steatohepatitis (NASH).
NASH means that the liver is swollen and damaged due to an accumulation of fat and that a certain degree of liver fibrosis (damaged and scarred liver tissue) is present.
The investigational drug Obeticholic acid (OCA) is a synthetic version of a naturally occurring compound produced in the liver, namely a bile acid. Bile acids are used by the body to aid digestion and also have other effects on liver function.
This study aims to determine how safe and effective OCA can be in stopping certain medical conditions or health-related complications that may occur in patients with NASH and evidence of liver fibrosis.
(BASEC)
Maladie en cours d'investigation
non-alcoholic fatty liver hepatitis (NASH)
(BASEC)
1. Evidence of non-alcoholic fatty liver hepatitis (NASH) based on microscopic tissue sections after liver biopsy. 2. Evidence of liver fibrosis based on microscopic tissue sections at stage 2 or 3 according to the NASH-CRN fibrosis classification. Or evidence of fibrosis based on microscopic tissue sections at stage 1a or 1b accompanied by at least one of the following risk factors: - Obesity (body mass index greater than 30 kg/m2) - Type 2 diabetes (sugar disease) - Elevated levels of the enzyme alanine aminotransferase 3. Stable body weight (i.e., no weight fluctuations of more than 10% in the last 3 months). (BASEC)
Critères d'exclusion
1. Current or past significant alcohol consumption in the 3 consecutive months within 1 year prior to screening. 2. Previous or planned surgery (during the study period) that is intended to result in weight reduction (e.g., gastric banding). 3. Evidence of other forms of chronic liver disease, such as: - Hepatitis B or C - Alcoholic liver disease - Known or suspected liver cancer - Liver cirrhosis (BASEC)
Lieu de l’étude
Berne, Lugano, St-Gall, Zurich
(BASEC)
Sponsor
non disponible
Contact pour plus d'informations sur l'étude
Personne de contact en Suisse
Prof. Dr. Annalisa Berzigotti
+41 31 632 21 11
Annalisa.Berzigotti@clutterinsel.ch(BASEC)
Informations générales
Intercept Pharmaceuticals
(ICTRP)
Informations scientifiques
Intercept Pharmaceuticals
(ICTRP)
Nom du comité d'éthique approbateur (pour les études multicentriques, uniquement le comité principal)
Commission cantonale d'éthique de Berne
(BASEC)
Date d'approbation du comité d'éthique
01.06.2016
(BASEC)
Identifiant de l'essai ICTRP
NCT02548351 (ICTRP)
Titre officiel (approuvé par le comité d'éthique)
non disponible
Titre académique
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 (ICTRP)
Titre public
Randomized Global Phase 3 Study to Evaluate the Impact on NASH With Fibrosis of Obeticholic Acid Treatment (ICTRP)
Maladie en cours d'investigation
Non Alcoholic Steatohepatitis (NASH) (ICTRP)
Intervention étudiée
Drug: Obeticholic Acid;Drug: Placebo (ICTRP)
Type d'essai
Interventional (ICTRP)
Plan de l'étude
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). (ICTRP)
Critères d'inclusion/exclusion
Gender: All
Maximum age: 85 Years
Minimum age: 18 Years
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.
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
(ICTRP)
non disponible
Critères d'évaluation principaux et secondaires
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;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) (ICTRP)
To evaluate the effect of Obeticholic Acid compared to placebo on liver histology in NASH;To evaluate the effect of Obeticholic Acid compared to placebo on liver histology in NASH;To evaluate the effect of Obeticholic Acid compared to placebo on liver biochemistry and markers of liver function (ICTRP)
Date d'enregistrement
non disponible
Inclusion du premier participant
non disponible
Sponsors secondaires
non disponible
Contacts supplémentaires
Sangeeta Sawhney, MD, Intercept Pharmaceuticals (ICTRP)
ID secondaires
747-303 (ICTRP)
Résultats-Données individuelles des participants
non disponible
Informations complémentaires sur l'essai
https://clinicaltrials.gov/ct2/show/NCT02548351 (ICTRP)
Résultats de l'essai
Résumé des résultats
non disponible
Lien vers les résultats dans le registre primaire
non disponible