Trial · NCT02200029
Study With Heptral in Subjects With Liver Disease Due to Alcohol Consumption
NCT02200029, Phase 3, Completed, Abbott
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study With Heptral in Subjects With Liver Disease Due to Alcohol Consumption. Trials, record NCT02200029. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02200029
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study With Heptral in Subjects With Liver Disease Due to Alcohol Consumption
- NCT number
- NCT02200029
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 75 participants, actual
- Lead sponsor
- Abbott
- Conditions
- Intrahepatic Cholestasis Associated With Alcoholic Liver Disease
- Interventions
- Ademetionine IV+tablet, Ademetionine tablet
- First posted
- 2014-07-25
- Last updated
- 2015-06-16
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | 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 | Improvement of ALP, γGT and serum total and conjugated bilirubin, ALT and AST compared to baseline |
| Secondary | 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 | Record of intensity of jaundice, pruritus, fatigue and depressed mood compared to baseline |
| Secondary | 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 | \>20% reduction of ALP or γGT or normalization of ALP or γGT compared to baseline |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02200029
GET https://conductscience.org/api/trials/v1/NCT02200029/registered