The purpose of this study is to explore the treatment effects of Selincro in alcohol dependent patients with liver impairment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
45
DE001
Heidelberg, Germany
DE002
Mannheim, Germany
Optuminisight
München, Germany
Change from baseline in the number of heavy drinking days per month (HDDs) (days/month)
Time frame: Baseline to months 1, 2 and 3
Change from baseline in the number of HDDs per week (days/week)
Time frame: Baseline to weeks 1 and 2
Change from baseline in total alcohol consumption (TAC) (g alcohol/day)
Time frame: Baseline to months 1, 2 and 3
Change from baseline in TAC (g alcohol/day)
Time frame: Baseline to weeks 1 and 2
Response Shift Drinking Risk Level (RSDRL)
Defined as a downward shift from baseline in drinking risk level (DRL); for patients with a very high DRL at baseline, a shift to medium DRL or lower; for patients with a high DRL at baseline, a shift to low DRL or below
Time frame: Baseline to month 3
Response Low Drinking Risk Level (RLDRL)
Defined as a downward shift from baseline in DRL to low DRL or below
Time frame: Baseline to month 3
Response defined as ≥70% reduction in TAC
Time frame: Baseline to month 3
Response defined as 0 to 4 HDDs (days/month)
Time frame: Month 3
Clinical Global Impression, global improvement (CGI-I).
Time frame: Weeks 4 and 12
Change from baseline in Clinical Global Impression, Severity of illness (CGI-S)
Time frame: Baseline to weeks 4 and 12
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Change in the Short-Form 36-Item Health Survey (SF-36)
Time frame: Baseline to week 12
Change in liver stiffness
Time frame: Baseline to weeks 1,2 4 and 12
Category shift in fibrosis stage
Time frame: Baseline to weeks 1,2 4, and 12
Change in transaminases and γ-glutamyl transferase (γGT)
Time frame: Baseline to weeks 1,2,4,8, and 12
Change in bilirubin, albumin, and International Normalized Ratio (INR)
Time frame: Baseline to weeks 1,2,4,8, and 12
Number of adverse events
Time frame: Screening to week 14