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

NCT02200029 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2015-06-16

No results posted yet for this study

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.

Conditions

  • Intrahepatic Cholestasis Associated With Alcoholic Liver Disease

Interventions

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

DRUG

Ademetionine tablet

oral ademetionine (500 mg/tablet, 2 in the morning and 1 before dinner) for 8 weeks

Sponsors & Collaborators

  • Ascent

    collaborator UNKNOWN

  • Datamap

    collaborator INDUSTRY

  • ClinIntel

    collaborator INDUSTRY

  • Catalent

    collaborator INDUSTRY

  • Abbott

    lead INDUSTRY

Principal Investigators

  • Suntje Sander-Struckmeier, PhD · Abbott

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-06-30
Primary Completion
2015-02-28
Completion
2015-02-28

Countries

  • Russia

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02200029 on ClinicalTrials.gov