Phase 2
N=55
Pentoxifylline in Patients With Nonalcoholic Steatohepatitis
Nonalcoholic Steatohepatitis
Bottom Line
View on ClinicalTrials.gov: NCT00590161 ↗Enrolled (actual)
55
Serious AEs
0.0%
Results posted
Sep 2013
Primary outcome: Primary: Histological Improvement of at Least 2 Points in NAFLD Activity Score (NAS) on Liver Biopsy After One Year. — -1.6; -0.1 NAS score units
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- pentoxifylline (PTX) (Drug); placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Case Western Reserve University
- Primary completion
- Jul 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Histological Improvement of at Least 2 Points in NAFLD Activity Score (NAS) on Liver Biopsy After One Year. |
-1.6; -0.1 | — |
Summary
One third of the population in the United States has nonalcoholic fatty liver disease (NAFLD). Nonalcoholic steatohepatitis (NASH), the progressive form of NAFLD, can lead to cirrhosis.Currently, there is no proven therapy for patients with NASH. The investigators core hypothesis is that therapy of patients with NASH with pentoxifylline (PTX) for one year will result in improvement of biochemical parameters of liver disease and hepatic histology. The focus of this proposal is on the effectiveness of pentoxifylline (PTX) in improving laboratory and tissue parameters of liver disease, parameters of insulin-resistance, and levels of cytokines in patients with NASH.
Eligibility Criteria
Inclusion Criteria
- Male and female patients ages 18 to 70 years.
- Liver biopsy compatible with NASH, including presence of steatosis and necroinflammatory activity on liver biopsy done during the prior 6 months to study enrollment
- Daily alcohol intake of 30 g daily for males and >15 g daily for females.
- Positive testing for hepatitis B surface antigen, hepatitis C virus antibody, or ribonucleic acid (RNA) of hepatitis C virus of deoxyribonucleic acid (DNA) of hepatitis B virus.
- Patients taking medications known to cause steatosis.
- Other causes of liver disease suspected by history, family interview, or laboratory testing.
- Patients with cirrhosis defined by stage 4 fibrosis on liver biopsy, or if the patient shows unequivocal clinical evidence of portal hypertension, such as thrombocytopenia, splenomegaly, or esophageal varices.
- Patients taking medications of possible benefit in NASH within 3 months prior to the liver biopsy. These medications include Vitamin E, Betaine, S-adenosylmethionine (SAM-e), thiazolidinediones, and acarbose.
- Patients with diabetes mellitus who are on Insulin therapy.
- Patients with diabetes mellitus on therapy with thiazolidinediones or alpha-glucosidase inhibitors such as acarbose
- Hypersensitivity to pentoxifylline or the methylxanthines (caffeine, theophylline, theobromine).
- History of cerebral or retinal hemorrhage.
- Other medical comorbidities (such as cardiac, central nervous system, renal, cancer) that would interfere with completion of the study.
- Patients taking Theophylline or Coumadin because of potential drug-drug interactions with Pentoxifylline.
- Pregnant or nursing women.
Data sourced from ClinicalTrials.gov (NCT00590161). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.