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Study With Heptral in Subjects With Liver Disease Due to Alcohol Consumption | Clinical Trials | Clareo Health

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Study With Heptral in Subjects With Liver Disease Due to Alcohol Consumption

Open-Label Study With Ademetionine (Heptral®) in Subjects With Intrahepatic Cholestasis (IHC) Associated With Alcoholic Liver Disease (ALD)

NCT02200029•Abbott

View on ClinicalTrials.gov

Summary

A research study of an approved drug called Heptral®, ademetionine, to treat adults with intrahepatic cholestasis (a condition where bile cannot flow from the liver to the duodenum) in pre-cirrhotic and cirrhotic states. Experience from clinical studies in subjects with liver disease has shown that ademetionine is effective.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Signed informed consent given by the subject
•Age ≥ 18 years to 75 years
•Chronic liver disease due to alcoholic liver disease
•Compensated alcoholic liver disease, defined as having a Maddrey Score \< 32 and not being treated with pentoxifylline or prednisolone within 6 months prior to the study
•History of chronic alcohol use, defined as, history of consumption of \> 40 g of alcohol per day for females and \> 80 g alcohol per day for males for more than 5 years prior to enrolment
•Subjects who abstain from alcohol for more than 2 weeks and will not consume alcohol during the study
•Subjects with Intrahepatic Cholestasis (IHC):
•ALP: more than 1.5 x upper normal limit and
•γGT: more than 3 x upper normal limit
•Subjects with additional serum conjugated bilirubin (SCB) \> Upper Limit of Normal (ULN) will be selected for initial IV treatment

Exclusion Criteria

•Subjects with a known hypersensitivity to the active substance of ademetionine or to any of the inactive ingredients
•Subjects with extrahepatic cause of cholestasis (proven by ultrasound or described in medical history)
•Diagnosis of human immunodeficiency virus (HIV) in medical history
•Subjects with chronic liver disease Child-Pugh class C
•Subjects in the decompensation stage of ALD (such as Maddrey Score \>32)
•Subjects with primary sclerosing cholangitis (PSC)
•Subjects with primary biliary cirrhosis (PBC)
•Any form of malignancy within the past 5 years and/or basal cell carcinoma and squamous cell carcinoma of the skin within the past two years
•Subjects with drug-induced liver disease
•History of active substance abuse (oral, inhaled or injected) within one year prior to the study
+18 more criteria

Locations (12)

Research facility ORG-000962

Moscow, Russia

Research facility ORG-000957

Moscow, Russia

Research facility ORG-000961

Moscow, Russia

Research facility ID ORG-000960

Moscow, Russia

Research facility ID ORG-000726

Moscow, Russia

Research facility ORG-000967

Saint Petersburg, Russia

Research facility ORG-000966

Saint Petersburg, Russia

Research facility ORG-000968

Saint Petersburg, Russia

Research facility ORG-000965

Saint Petersburg, Russia

Research facility ORG-000970

Saint Petersburg, Russia

Key Dates

Start Date

June 1, 2014

Primary Completion Date

February 1, 2015

Completion Date

February 1, 2015

Last Updated

June 16, 2015

Enrollment

ACTUAL participants

Conditions

Intrahepatic Cholestasis Associated With Alcoholic Liver Disease

Interventions

Ademetionine IV+tablet

DRUG

Ademetionine tablet

DRUG