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Ademetionine +

Phase 3

Intrahepatic Cholestasis Associated With Alcoholic Liver Disease | Small molecule | Gastrointestinal |Abbott Laboratories|Last Updated: Jun 16, 2015

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
CONTROLLEDBiomarker
Total Trials1
Total Enrollment75
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02200029Study With Heptral in Subjects With Liver Disease Due to Alcohol ConsumptionPHASE3 COMPLETED 75 — — Jun 1, 2014Feb 1, 2015Jun 16, 201512 Russia
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Study Endpoints
Primary Endpoints
Concentrations (Units per liter) of Alkaline phosphatase (ALP) or gamma-glutamyltransferase (γGT)
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 Endpoints
Concentrations of ALP, γGT, Alanine Transaminase (ALT) and Aspartate aminotransferase (AST) (Units per liter) and of serum total and conjugated bilirubin (µmol per liter)
At baseline and after 2 weeks intravenously (IV) treatment or after 4 weeks oral treatment and after 2 months treatment
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).
At baseline and after 2 weeks IV treatment or after 4 weeks oral treatment and after 2 months treatment
Evaluation of the responder rate by comparing concentrations at certain time points (units per liter) to baseline concentrations
At baseline and after 2 weeks IV treatment or after 4 weeks oral treatment and after 2 months treatment
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Ademetionine IVEXPERIMENTAL -
Ademetionine oralEXPERIMENTAL -
Interventions
NameTypeDescription
Ademetionine IV+tabletDRUGIV 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
Ademetionine tabletDRUGoral ademetionine (500 mg/tablet, 2 in the morning and 1 before dinner) for 8 weeks
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Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites12

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 mo...

Countries:Russia
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