CompletedPhase 3

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

Russia75 participantsStarted 2014-06

Plain-language 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.

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Concentrations (Units per liter) of Alkaline phosphatase (ALP) or gamma-glutamyltransferase (γGT)

Timeframe: from baseline up to the end of treatment visit (56-60 days)

Trial details

NCT IDNCT02200029

SponsorAbbott

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2015-02

View on ClinicalTrials.gov More Intrahepatic Cholestasis Associated With Alcoholic Liver Disease trials