An observational study in Alcoholic Liver Disease, sponsored by Nicole T Shen. Recruiting at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2019-03-13.
Sponsored by Nicole T Shen · Observational
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Among 23 studies in Liver Diseases, Alcoholic with a site in United States — 7 open to participants now, 9 under way, none of them phase 3. Liver Diseases, Alcoholic · United States.
Among the 23 studies in Liver Diseases, Alcoholic with a site in United States, this one is the only one that started in 2016, is one of 7 observational ones, and was the 10th registered.
74 studies on the registry are indexed under Liver Diseases, Alcoholic; 25 are open to participants now.
Browse Liver Diseases, Alcoholic studies →7 of the 23 studies in Liver Diseases, Alcoholic with a site in United States are open now. Recruiting first, the newest first:
GlaxoSmithKline · Sites in United States, Argentina, Canada and 1 more country
Ages 18–75
GlaxoSmithKline · Sites in United States, Argentina, Australia and 16 more countries
Ages 18–70
The Cleveland Clinic · Sites in United States
Ages 21+
The Cleveland Clinic · Sites in United States
Ages 18–75 · Healthy volunteers
The Cleveland Clinic · Sites in United States
Ages 18–65 · Healthy volunteers
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 18 Liver Diseases, Alcoholic studies recruiting now, 7 (39%) set no upper age limit and 7 (39%) stop at 75 or younger; none take children under 18; 4 take healthy volunteers.
This study: 18 Years to 80 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
23 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 2 · Phase 2 6 · Phase 3 2
First in 2003; this study’s year is marked. 1 started in 2016.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 160 is below the median of 439 across 28 observational studies indexed under Liver Diseases, Alcoholic.
Median enrollment 41 across the 16 interventional studies, 160 across the 7 observational. Of the 13 that completed or were terminated, 4 (31%) have results posted.
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4 of 23 have an industry lead sponsor. The 10 most frequent:
This is the only study on the registry with Nicole T Shen as lead sponsor.
Nicole T Shen has 1 study filed under Liver Diseases, Alcoholic — fewer than ten, so there is no comparison to draw.
2 of the studies in Liver Diseases, Alcoholic with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT03224949The Cleveland ClinicComparison of ALD, NASH, and Healthy Control Patients | 2027-09-30 |
| NCT06613698GlaxoSmithKlineA Study to Investigate the Safety and Efficacy of GSK4532990 Compared With Placebo in Adult Participants Aged 18 to 70 Years With Alcohol-related Liver Disease | 2027-11-26 |
Add all 2 to your calendar (.ics) → With an account.
Among the 23 studies in Liver Diseases, Alcoholic with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This prospective, analytic observational study will investigate alcohol recidivism in patients with alcoholic liver disease. All adult subjects presenting with alcoholic liver disease are considered for inclusion. Subjects able to give consent are included.
This is a longitudinal observational study. Subjects with a diagnosis of alcoholic liver disease (acute alcoholic hepatitis or alcoholic cirrhosis) who present to Weill Cornell Medical Center or Columbia University Medical Center New York Presbyterian Hospital or the Gastroenterology and Hepatology Clinic will be invited to join this study, which entails a survey at baseline and follow-up at 3, 6, 9, 12, 15, and 18 months and then at 2, 5, and 10 years. Follow-up will consist of a chart review, a phone or in person interview, and most recent clinic visit interview for alcohol recidivism. The clinical providers will be blinded to the survey results.
subjects with alcoholic liver disease
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Patients with alcohol liver disease consenting to participate in the study will be administered an initial survey at inclusion and then follow-up surveys at 3, 6, 9, 12, 15, and 18 month intervals and then 2, 5, and 10 years. There is no intervention cohort, all enrolled will complete the same surveys. Recidivism will be measured by responses to survey questions, clinical interviews documented in the chart, and urine ethnyl glucuronide or blood ethanol testing.
Other: survey
surveys will be administered at inclusion and follow-ups
alcohol recidivism assessed by questionnaire
Follow-up questionnaires will be administered at 6 months assessing for alcohol use
Time frame: 6 months
alcohol recidivism assessed by clinical interview
Follow-up interviews will be conducted at 6 months assessing for alcohol use
Time frame: 6 months
alcohol recidivism assessed by urine ethyl glucuronide
Follow-up urine testing may be conducted at 6 months assessing for alcohol use
Time frame: 6 months
alcohol recidivism assessed by blood
Follow-up blood testing may be conducted at 6 months assessing for alcohol use
Time frame: 6 months
alcohol recidivism assessed by questionnaire
Follow-up questionnaires will be administered after 6 months assessing for alcohol use
Time frame: after 6 months
alcohol recidivism assessed by clinical interview
Follow-up clinical interviews will be conducted after 6 months assessing for alcohol use
Time frame: after 6 months
alcohol recidivism assessed by urine ethyl glucuronide
Follow-up urine testing may be conducted after 6 months assessing for alcohol use
Time frame: after 6 months
alcohol recidivism assessed by blood
Follow-up blood testing may be conducted after 6 months assessing for alcohol use
Time frame: after 6 months
Plan to share: No
No publications or documents are linked to this record.
Started Nov 2016 (actual). Primary completion is estimated for Nov 2026, 119 months after the start.
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