Clinical Trial: Study With Heptral in Subjects With Liver Disease Due to Alcohol Consumption

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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.

Detailed Summary:
Sponsor: Abbott

Current Primary Outcome: 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


Original Primary Outcome: 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


Current Secondary Outcome:

  • 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
  • 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
  • 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


Original Secondary Outcome:

  • ALP, γGT and serum total and conjugated bilirubin, Alanine Transaminase (ALT) and Aspartate aminotransferase (AST) [ 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
  • 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
  • Evaluation of the responder rate [ 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


Information By: Abbott

Dates:
Date Received: July 21, 2014
Date Started: June 2014
Date Completion:
Last Updated: June 15, 2015
Last Verified: June 2015