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Pentoxifylline in Patients With Nonalcoholic Steatohepatitis

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ClinicalTrials.gov Identifier: NCT00590161
Recruitment Status : Completed
First Posted : January 10, 2008
Results First Posted : September 26, 2013
Last Update Posted : September 26, 2013
Sponsor:
Collaborator:
American College of Gastroenterology
Information provided by (Responsible Party):
Claudia Zein, Case Western Reserve University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Nonalcoholic Steatohepatitis
Interventions Drug: pentoxifylline (PTX)
Drug: placebo
Enrollment 55
Recruitment Details Patients were recruited between December 2006 and February 2009 at the Liver Clinics of both participating institutions.
Pre-assignment Details Patients were randomized in a double-blind fashion. Double blinding was maintained until study completion by all subjects.
Arm/Group Title Pentoxifylline (PTX) 400 mg PO Three Times Daily (TID) Placebo TID
Hide Arm/Group Description 26 subjects received PTX at dose above for one year 29 subjects received placebo as above for one year
Period Title: Overall Study
Started 26 29
Completed 23 26
Not Completed 3 3
Arm/Group Title Pentoxifylline (PTX) 400 mg PO (by Mouth) TID Placebo TID Total
Hide Arm/Group Description 26 subjects received PTX at dose above for one year 29 subjects received placebo as above for one year Total of all reporting groups
Overall Number of Baseline Participants 26 29 55
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants 29 participants 55 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
23
  88.5%
27
  93.1%
50
  90.9%
>=65 years
3
  11.5%
2
   6.9%
5
   9.1%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 26 participants 29 participants 55 participants
50.5  (12.7) 49.6  (9.6) 50  (11.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants 29 participants 55 participants
Female
8
  30.8%
9
  31.0%
17
  30.9%
Male
18
  69.2%
20
  69.0%
38
  69.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 26 participants 29 participants 55 participants
26 29 55
1.Primary Outcome
Title Histological Improvement of at Least 2 Points in NAFLD Activity Score (NAS) on Liver Biopsy After One Year.
Hide Description The NAFLD Activity Score (NAS) grades NAFLD on liver biopsy based on the individual scoring of steatosis, inflammation and balloning. The NAS is assessed on a scale of 0 to 8 with higher scores indicating more severe disease and lower scores indicating less severe disease. NAS is obtained by adding steatosis(assessed on a scale of 0 to 3), inflammation (assessed on a scale of 0 to 3) and ballooning (assessed on a scale of 0 to 2).
Time Frame 1 year (Baseline liver biopsy done at study entry, and subsequent liver biopsy done after one year of therapy with pentoxifylline or placebo)
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat analysis included all participants and for this analysis patients without available end of study liver biopsy were imputed as treatment failures. Results showed here are continuous variable analysis of NAS score change in patients with available end of study liver biopsy (per protocol analysis)
Arm/Group Title Pentoxifylline 400 mg PO Tid Placebo Tid
Hide Arm/Group Description:
26 subjects received PTX at dose above for one year
29 subjects received placebo as above for one year
Overall Number of Participants Analyzed 20 26
Mean (Standard Deviation)
Unit of Measure: NAS score units
-1.6  (1.1) -0.1  (1.4)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Pentoxifylline 400 mg PO Tid Placebo Tid
Hide Arm/Group Description 26 subjects received PTX at dose above for one year 29 subjects received placebo as above for one year
All-Cause Mortality
Pentoxifylline 400 mg PO Tid Placebo Tid
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Pentoxifylline 400 mg PO Tid Placebo Tid
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/26 (0.00%)      0/29 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Pentoxifylline 400 mg PO Tid Placebo Tid
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   11/26 (42.31%)      14/29 (48.28%)    
Gastrointestinal disorders     
Nausea   6/26 (23.08%)  6 4/29 (13.79%)  4
Bloating   2/26 (7.69%)  2 3/29 (10.34%)  3
Abdominal pain   0/26 (0.00%)  0 2/29 (6.90%)  2
Diarrhea   1/26 (3.85%)  1 3/29 (10.34%)  3
General disorders     
Headache   2/26 (7.69%)  2 1/29 (3.45%)  1
Lightheadedness   1/26 (3.85%)  1 3/29 (10.34%)  3
Chest pain   0/26 (0.00%)  0 2/29 (6.90%)  2
Fatigue   0/26 (0.00%)  0 2/29 (6.90%)  2
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Claudia O. Zein, MD, MSc
Organization: Cleveland Clinic Lerner College of Medicine of Case Western Reserve University
Phone: 216-444-0421
EMail: zeinc@ccf.org
Layout table for additonal information
Responsible Party: Claudia Zein, Case Western Reserve University
ClinicalTrials.gov Identifier: NCT00590161     History of Changes
Other Study ID Numbers: R-1196 CWRU CRU
First Submitted: December 26, 2007
First Posted: January 10, 2008
Results First Submitted: March 7, 2012
Results First Posted: September 26, 2013
Last Update Posted: September 26, 2013