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NCT01245257 Clinical Trial

Effects of Prednisolone and Pentoxifylline on the Regulation of Urea Synthesis in Alcoholic Hepatitis

Alcoholic Hepatitis Clinical Trial

Official title:
Effects of Prednisolone and Pentoxifylline on the Regulation of Urea Synthesis in Alcoholic Hepatitis

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01245257
Other study ID # FHNC-Alk-Hep
Secondary ID
Status Completed
Phase N/A
First received November 15, 2010
Last updated September 9, 2016
Start date November 2010
Est. completion date June 2015

Study information
Verified date December 2013
Source University of Aarhus
Contact n/a
Is FDA regulated No
Health authority Denmark: The Regional Committee on Biomedical Research Ethics
Study type Observational

Clinical Trial Summary

Loss of total mass of muscles (catabolism) is a serious clinical problem in patients with alcoholic hepatitis. The liver might play an important role in this stress-catabolism by increasing the production of urea during the inflammatory process.

The purpose of this study is to examine the regulation of urea synthesis in patients with alcoholic hepatitis and to study the effect of the anti-inflammatory drugs prednisolone and pentoxifylline on this regulation.

Recruitment information / eligibility
Status Completed
Enrollment 50
Est. completion date June 2015
Est. primary completion date June 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

- Alcoholic hepatitis (alcohol intake (> 40g/day in 6 months), bilirubin > 80 µmol/l)

Exclusion Criteria:

- Severe bacterial infections

- Other chronical inflammatory diseases

- Cancer

- Other catabolic diseases

- Treatment with prednisolone or pentoxifylline within the last 8 weeks

Study Design

Observational Model: Case-Crossover, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Denmark Department of Medicine V, Aarhus University Hospital Aarhus

Sponsors (1)
Lead Sponsor Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary Functional Hepatic Nitrogen Clearance At inclusion, after approximately 3 month and if severe alcoholic hepatitis also after 14 days medical treatment No
Secondary Clinical and biochemical measures of inflammation At inclusion, after approximately 3 month and if severe alcoholic hepatitis also after 14 days medical treatment No
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