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

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: NCT02200029
Recruitment Status : Completed
First Posted : July 25, 2014
Last Update Posted : June 16, 2015
Sponsor:
Collaborators:
Ascent
Datamap
ClinIntel
Catalent
Information provided by (Responsible Party):
Abbott

Study Description
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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 and cirrhotic states. Experience from clinical studies in subjects with liver disease has shown that ademetionine is effective.

Condition or disease Intervention/treatment Phase
Intrahepatic Cholestasis Associated With Alcoholic Liver Disease Drug: Ademetionine IV+tablet Drug: Ademetionine tablet Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open-Label Study With Ademetionine (Heptral®) in Subjects With Intrahepatic Cholestasis (IHC) Associated With Alcoholic Liver Disease (ALD)
Study Start Date : June 2014
Actual Primary Completion Date : February 2015
Actual Study Completion Date : February 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Liver Diseases

Arms and Interventions
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Arm Intervention/treatment
Experimental: Ademetionine IV Drug: Ademetionine IV+tablet
IV ademetionine (500 mg/vial) for 2 weeks followed by oral ademetionine (500 mg/tablet, 2 in the morning and 1 before dinner) for 6 weeks
Experimental: Ademetionine oral Drug: Ademetionine tablet
oral ademetionine (500 mg/tablet, 2 in the morning and 1 before dinner) for 8 weeks


Outcome Measures
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Primary Outcome Measures :
  1. Concentrations (Units per liter) of Alkaline phosphatase (ALP) or gamma-glutamyltransferase (γGT) [ Time Frame: from baseline up to the end of treatment visit (56-60 days) ]
    Improvement of ALP or γGT after 8 weeks of treatment with ademetionine compared to baseline


Secondary Outcome Measures :
  1. Concentrations of ALP, γGT, Alanine Transaminase (ALT) and Aspartate aminotransferase (AST) (Units per liter) and of serum total and conjugated bilirubin (µmol per liter) [ Time Frame: At baseline and after 2 weeks intravenously (IV) treatment or after 4 weeks oral treatment and after 2 months treatment ]
    Improvement of ALP, γGT and serum total and conjugated bilirubin, ALT and AST compared to baseline

  2. The intensity of clinical symptoms (jaundice, pruritus, fatigue and depressed mood) will be recorded for each symptom separately using six categories: No symptoms (0), minimum (1) to maximum (5). [ Time Frame: At baseline and after 2 weeks IV treatment or after 4 weeks oral treatment and after 2 months treatment ]
    Record of intensity of jaundice, pruritus, fatigue and depressed mood compared to baseline

  3. Evaluation of the responder rate by comparing concentrations at certain time points (units per liter) to baseline concentrations [ Time Frame: At baseline and after 2 weeks IV treatment or after 4 weeks oral treatment and after 2 months treatment ]
    >20% reduction of ALP or γGT or normalization of ALP or γGT compared to baseline


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02200029


Locations
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Russian Federation
Research facility ORG-000962
Moscow, Russian Federation, 107014
Research facility ORG-000957
Moscow, Russian Federation, 117292
Research facility ORG-000961
Moscow, Russian Federation, 119435
Research facility ID ORG-000960
Moscow, Russian Federation, 119992
Research facility ID ORG-000726
Moscow, Russian Federation, 125284
Research facility ORG-000967
St. Petersburg, Russian Federation, 117630
Research facility ORG-000966
St. Petersburg, Russian Federation, 191015
Research facility ORG-000968
St. Petersburg, Russian Federation, 195257
Research facility ORG-000965
St. Petersburg, Russian Federation, 197022
Research facility ORG-000970
St. Petersburg, Russian Federation, 198216
Research facility ORG-000958
Troitsk, Russian Federation, 142190
Research facility ORG-000969
Yaroslavl, Russian Federation, 150003
Sponsors and Collaborators
Abbott
Ascent
Datamap
ClinIntel
Catalent
Investigators
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Study Director: Suntje Sander-Struckmeier, PhD Abbott
More Information
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Responsible Party: Abbott
ClinicalTrials.gov Identifier: NCT02200029    
Other Study ID Numbers: M14-168
First Posted: July 25, 2014    Key Record Dates
Last Update Posted: June 16, 2015
Last Verified: June 2015
Keywords provided by Abbott:
Intrahepatic Cholestasis
Additional relevant MeSH terms:
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Liver Diseases
Cholestasis
Liver Diseases, Alcoholic
Cholestasis, Intrahepatic
Digestive System Diseases
Bile Duct Diseases
 Biliary Tract Diseases
Alcohol-Induced Disorders
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders