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NCT01846819 · ClinicalTrials.gov registry record

Factors Associated With End Stage Liver Disease

A clinical trial, sponsored by NYU Langone Health.

Terminated
Registry status
27
Enrollment target

NCT01846819: Clinical Trial study, sponsored by NYU Langone Health.

NCT01846819 is a clinical trial that was terminated before completion, run by NYU Langone Health. The registered enrollment target is 27 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01846819 was terminated before completion, sponsored by NYU Langone Health.

TERMINATED
Registry status
27 participants
Enrollment target

Study Summary

100 ambulatory cirrhotic patients attending a liver transplant clinic will undergo a comprehensive clinical evaluation for severity of liver disease, anemia, depression, and fatigue. Fatigue will be assessed with the FIS and sub-maximal exercise capacity with the 6-minute walk test (6MWT), a standardized exercise test that measures the distance that a patient is capable of walking in 6 minutes (6MWD). Depression will be assessed by using three well-known questionnaires. The SF-36, Beck's Depression Inventory (BDI-II), EQ-5D, and the Psychological General Well-Being Index (PGWBI). Univariate analysis will be performed to select the factors that potentially are associated with the scores as indicated by a P value \<.20; the selected factors will then be entered in a stepwise regression to create a multivariate model giving the combination of factors that are significantly associated with the measure of fatigue and depression. Hemoglobin (Hb) levels will then be added to the model in order to test its significance while controlling for the other factors.

Primary Outcome

Patients undergo 6 minute walk test and complete Fisk Impact Scale (Fatigue Questionaire)

Trial Details

FieldValue
Enrollment Target 27 participants
Start Date 2012-07
Est. Completion 2014-12
NYU Langone Health

1,164 total trials

Why NCT01846819 stopped before completion

NCT01846819 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 27 participants, a relatively small participant target.

The record links to 0 conditions, and to 0 interventions.

NCT01846819 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01846819 about?

NCT01846819 is a clinical study titled "Factors Associated With End Stage Liver Disease". 100 ambulatory cirrhotic patients attending a liver transplant clinic will undergo a comprehensive clinical evaluation for severity of liver disease, anemia, depression, and fatigue. Fatigue will be assessed with the FIS and sub-maximal exercise capacity with the 6-minute walk test (6MWT), a standar...

What is the current status of trial NCT01846819?

This trial is currently terminated. The enrollment target is 27 participants. The study started on 2012-07. Estimated completion is 2014-12.

Who is sponsoring clinical trial NCT01846819?

This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT01846819, the US trial registry maintained by the National Library of Medicine. NCT01846819 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.