Status:
COMPLETED
Study With Heptral in Subjects With Liver Disease Due to Alcohol Consumption
Lead Sponsor:
Abbott
Collaborating Sponsors:
Ascent
Datamap
Conditions:
Intrahepatic Cholestasis Associated With Alcoholic Liver Disease
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief 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 a...
Eligibility Criteria
Inclusion
- 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
- Subjects with renal impairment (creatinine level of \>2.0 mg/dL or \> 150 µmol/l)
- Subjects with known genetic defects affecting the methionine cycle and/or causing homocystinuria and/or hyperhomocysteinemia (e.g., cystathionine beta-synthase deficiency, Vitamin B12 metabolism defect) or known folate, Vitamin B6 or B12 deficiency
- Subjects on total parenteral nutrition in the year prior to screening
- Subjects after or planned for bariatric surgery (jejunoileal bypass or gastric weight loss surgery)
- Subjects after liver transplantation and subjects on the waiting list for liver transplantation
- Subjects with any of the following disease in medical history:
- Viral hepatitis (serum positive HBcAb or Hepatitis C Virus (HCV) RNA)
- Evidence of autoimmune liver disease
- Wilson´s disease
- Hemochromatosis
- Alpha-1-antitrypsin deficiency
- Subjects with history of biliary diversion
- History of major depression or bipolar disease
- Women of childbearing potential: positive urine pregnancy test during screening or unwillingness to use an effective form of birth control during the study.
- Breastfeeding women
- Any condition that, in the opinion of the investigator, does not justify the patient's inclusion into the study
- Investigational drug intake within one month prior to the study
- Active, serious medical disease other than ALD with likely life-expectancy less than five years
Exclusion
Key Trial Info
Start Date :
June 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2015
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT02200029
Start Date
June 1 2014
End Date
February 1 2015
Last Update
June 16 2015
Active Locations (12)
Enter a location and click search to find clinical trials sorted by distance.
1
Research facility ORG-000962
Moscow, Russia, 107014
2
Research facility ORG-000957
Moscow, Russia, 117292
3
Research facility ORG-000961
Moscow, Russia, 119435
4
Research facility ID ORG-000960
Moscow, Russia, 119992