NCT00590161

Pentoxifylline in Patients With Nonalcoholic Steatohepatitis

Treatment Efficacy of Pentoxifylline in Patients With Nonalcoholic Steatohepatitis: A Double-blind Randomized Placebo Controlled Trial

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: Case Western Reserve University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Nonalcoholic Steatohepatitis

Interventions

Type	Name	Description
DRUG	pentoxifylline (PTX)	400 mg PO tid
DRUG	placebo	placebo tid

Timeline

• Start date: 2006-12-01
• Primary completion: 2010-07-01
• Completion: 2010-12-01
• First posted: 2008-01-10
• Last updated: 2013-09-26
• Results posted: 2013-09-26

Locations

3 sites across 1 country: United States