Pentoxifylline in Patients With Nonalcoholic Steatohepatitis
Information source: Case Western Reserve University
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Nonalcoholic Steatohepatitis
Intervention: pentoxifylline (Drug); placebo (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Case Western Reserve University Official(s) and/or principal investigator(s):
Claudia O Zein, MD, MSc, Principal Investigator, Affiliation: Case Western Reserve University
Overall contact:
Claudia O Zein, MD, MSc, Phone: 216-791-3800, Ext: 5259, Email: claudia.zein@case.edu
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. Our core hypothesis
is that therapy of patients with NASH with pentoxifylline 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 in improving laboratory and tissue
parameters of liver disease, parameters of insulin-resistance, and levels of cytokines in
patients with NASH.
Clinical Details
Official title: Treatment Efficacy of Pentoxifylline in Patients With Nonalcoholic Steatohepatitis: A Double-Blind Randomized Placebo Controlled Trial
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Histological improvement of disease on liver biopsy measured by NAS
Eligibility
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Both.
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 for males and <15 g for females;
- Appropriate exclusion of other liver diseases.
- Patients with diabetes mellitus type 2 diagnosis as defined by a previous diagnosis
of DM and current therapy with antidiabetic agents, or by fulfillment of 1997 ADA
criteria, may be included if they fulfill the following criteria: (i) therapeutic
regimen limited to specific oral agents including sulfonylureas (e. g. glipizide and
glyburide) and/or biguanides (e. g. metformin); (ii) stable therapeutic regimen as
defined by no changes in oral agents for at least 3 months; (iii) HgbA1C < 8. 5 %.
Exclusion Criteria:
- History of past excessive alcohol drinking (as defined above) for a period longer
than 2 years at any time in the past 10 years.
- Current consumption of alcohol >30 g daily for males and >15 g daily for females.
- Positive testing for hepatitis B surface antigen, hepatitis C virus antibody, or RNA
of hepatitis C virus of 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.
Locations and Contacts
Claudia O Zein, MD, MSc, Phone: 216-791-3800, Ext: 5259, Email: claudia.zein@case.edu
Louis Stokes VA Medical Center, Cleveland, Ohio 44106, United States; Recruiting
Claudia O Zein, MD, MSc, Phone: 216-791-3800, Ext: 5259, Email: claudia.zein@case.edu
Beth Bednarchik, RN, Phone: 216-844-7314, Email: beth.bednarchik@uhhs.org
Claudia O. Zein, MD, MSc, Principal Investigator
University Hospitals Case Medical Center, Cleveland, Ohio 44106, United States; Recruiting
Beth Bednarchik, RN, Phone: 216-844-7314, Email: beth.bednarchik@uhhs.org
Claudia O Zein, MD, MSc, Principal Investigator
Anthony B. Post, MD, Sub-Investigator
Pierre M. Gholam, MD, Sub-Investigator
Cleveland Clinic, Cleveland, Ohio 44195, United States; Recruiting
Ruth Sargent, LPN, Phone: 216-444-3126, Email: sargenr@ccf.org
Arthur J McCullough, MD, Principal Investigator
Metrohealth Medical Center, Cleveland, Ohio 44109, United States; Not yet recruiting
Additional Information
Starting date: December 2006
Ending date: June 2009
Last updated: December 26, 2007
|
