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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by University of Aarhus
Information provided by (Responsible Party):
University of Aarhus Identifier:
First received: November 15, 2010
Last updated: December 9, 2013
Last verified: December 2013

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.

Alcoholic Hepatitis

Study Type: Observational
Study Design: Observational Model: Case-Crossover
Time Perspective: Prospective
Official Title: Effects of Prednisolone and Pentoxifylline on the Regulation of Urea Synthesis in Alcoholic Hepatitis

Resource links provided by NLM:

Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Functional Hepatic Nitrogen Clearance [ Time Frame: At inclusion, after approximately 3 month and if severe alcoholic hepatitis also after 14 days medical treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical and biochemical measures of inflammation [ Time Frame: At inclusion, after approximately 3 month and if severe alcoholic hepatitis also after 14 days medical treatment ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Serum, plasma, urine

Estimated Enrollment: 50
Study Start Date: November 2010
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Alcoholic Hepatitis
Patients with alcoholic hepatitis


Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients with alcoholic hepatitis admitted to hospital for treatment.


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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01245257

Contact: Karen Louise Thomsen, MD +45 89493897

Department of Medicine V, Aarhus University Hospital Recruiting
Aarhus, Denmark, 8000
Contact: Karen Louise Thomsen, MD    +45 89493897   
Sponsors and Collaborators
University of Aarhus
Principal Investigator: Karen Louise Thomsen, MD Aarhus University Hospital
  More Information

No publications provided

Responsible Party: University of Aarhus Identifier: NCT01245257     History of Changes
Other Study ID Numbers: FHNC-Alk-Hep
Study First Received: November 15, 2010
Last Updated: December 9, 2013
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by University of Aarhus:
Urea Synthesis
Nitrogen balance

Additional relevant MeSH terms:
Hepatitis A
Hepatitis, Alcoholic
Alcohol-Induced Disorders
Alcohol-Related Disorders
Chemically-Induced Disorders
Digestive System Diseases
Enterovirus Infections
Hepatitis, Viral, Human
Liver Diseases
Liver Diseases, Alcoholic
Picornaviridae Infections
RNA Virus Infections
Substance-Related Disorders
Virus Diseases
Anti-Inflammatory Agents
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Cardiovascular Agents
Enzyme Inhibitors
Free Radical Scavengers
Hematologic Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions processed this record on November 20, 2014