CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 55 enrolled
Drug / intervention
pentoxifylline (PTX) +1 moredrug
Likely dose
pentoxifylline (PTX) 400 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00590161
NCT00590161Phase 2Completed

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

Case Western Reserve University·interventional·Posted Jan 10, 2008·Updated Sep 26, 2013

In Brief

A Phase 2 clinical trial evaluating pentoxifylline (PTX) and placebo for Nonalcoholic Steatohepatitis. Completed, enrolled 55 participants across 3 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 10, 2008
Enrollment StartDec 1, 2006
Primary CompletionJul 1, 2010
Study CompletionDec 1, 2010
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 18.5 years ago

Interventions

pentoxifylline (PTX)drug

400 mg PO tid

placebodrug

placebo tid