Pentoxifylline for Acute Alcoholic Hepatitis (AAH)

This study has been terminated.
(lack of funding)
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00205049
First received: September 13, 2005
Last updated: April 10, 2014
Last verified: April 2014
Results First Received: August 4, 2011  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Hepatitis, Alcoholic
Intervention: Drug: pentoxifylline

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Pentoxifylline All subjects will be randomized to receive either pentoxifylline 400mg orally or placebo 3 times daily for 28 days
Placebo All subjects will be randomized to receive either pentoxifylline 400mg orally or placebo 3 times daily for 28 days

Participant Flow:   Overall Study
    Pentoxifylline     Placebo  
STARTED     0     0  
COMPLETED     0     0  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Pentoxifylline All subjects will be randomized to receive either pentoxifylline 400mg orally or placebo 3 times daily for 28 days
Placebo All subjects will be randomized to receive either pentoxifylline 400mg orally or placebo 3 times daily for 28 days
Total Total of all reporting groups

Baseline Measures
    Pentoxifylline     Placebo     Total  
Number of Participants  
[units: participants]
  0     0     0  
Age  
[units: participants]
     
<=18 years              
Between 18 and 65 years              
>=65 years              
Gender, Customized  
[units: 0]
     
Male              
Female              



  Outcome Measures

1.  Primary:   Survival at 28 Days   [ Time Frame: 28 days ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Study was terminated before any data was gathered/analyzed.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Research Program Manager - Kelly Richie
Organization: University of Wisconsin
phone: 608-262-5404
e-mail: kr2@medicine.wisc.edu


No publications provided


Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00205049     History of Changes
Other Study ID Numbers: M-2004-0388
Study First Received: September 13, 2005
Results First Received: August 4, 2011
Last Updated: April 10, 2014
Health Authority: United States: Institutional Review Board