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

June 15, 2015 updated by: Abbott

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
75

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
      • Moscow, Russian Federation, 107014
        • Research facility ORG-000962
      • Moscow, Russian Federation, 117292
        • Research facility ORG-000957
      • Moscow, Russian Federation, 119435
        • Research facility ORG-000961
      • Moscow, Russian Federation, 119992
        • Research facility ID ORG-000960
      • Moscow, Russian Federation, 125284
        • Research facility ID ORG-000726
      • St. Petersburg, Russian Federation, 117630
        • Research facility ORG-000967
      • St. Petersburg, Russian Federation, 191015
        • Research facility ORG-000966
      • St. Petersburg, Russian Federation, 195257
        • Research facility ORG-000968
      • St. Petersburg, Russian Federation, 197022
        • Research facility ORG-000965
      • St. Petersburg, Russian Federation, 198216
        • Research facility ORG-000970
      • Troitsk, Russian Federation, 142190
        • Research facility ORG-000958
      • Yaroslavl, Russian Federation, 150003
        • Research facility ORG-000969

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
from baseline up to the end of treatment visit (56-60 days)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
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).
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
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
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
At baseline and after 2 weeks IV treatment or after 4 weeks oral treatment and after 2 months treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Abbott

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Ascent
Datamap
ClinIntel
Catalent

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 21, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 24, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 25, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 16, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 15, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • M14-168

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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