Pentoxifylline/Nonalcoholic Steatohepatitis (NASH) Study: The Effect of Pentoxifylline on NASH

Completed · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Nonalcoholic Steatohepatitis, Liver Diseases

In brief

The purpose of this study is to explore the potential benefit of the medication, pentoxifylline, for the treatment of NASH.

Key facts

Study ID

NCT00267670

Run by

Northwestern University

People needed

26

Starts

2005-03-01

Expected to finish

2009-09-01

Last updated by the study team

2014-09-09

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects must be willing to give written informed consent
• Diagnosis of steatohepatitis Grade >= 1 (Brunt et al. criteria - Am J Gastroenterology 1999;94(9)2467-74) on biopsy within 6 months prior to entry into protocol
• No histologic evidence of cirrhosis
• Persistent ALT elevation (> 1.5 the upper limit normal) over 6 months prior to entry into study
• Adult subjects 18-65 years of age of any race or gender
• Compensated liver disease with the following hematologic, biochemical, and serological criteria on entry into protocol:
• Hemoglobin > 11 gm/dL for females and > 12 gm/dL for males
• White blood cell (WBC) > 2.5 K/UL
• Neutrophil count > 1.5 K/UL
• Platelets > 100 K/UL
• Direct bilirubin, within normal limits
• Indirect bilirubin within normal limits (unless non-hepatitis factors such as Gilbert's disease explain indirect bilirubin rise. In such cases total bilirubin must be < 3.0 mg/dL)
• Albumin > 3.2 g/dL
• Serum creatinine within normal limits
• Hemoglobin A1c (HgbA1c) < 7%
• Antinuclear antibodies (ANA) < 1:160
• Anti-smooth muscle Ab negative
• Serum hepatitis B surface antigen (HepBsAg) negative
• Serum hepatitis C antibody (HepC Ab) negative
• Iron/total iron binding capacity (TIBC) ratio (transferrin saturation) < 45%
• Alpha-1-antitrypsin level within normal limits
• Ceruloplasmin level within normal limits
• Negative pregnancy test (females)
• Concomitant use of lipid lowering agents at study entry will not exclude patients from the study.

You may not qualify if…

• Evidence of decompensated cirrhosis
• Active gastrointestinal (GI) bleeding
• Renal failure (creatinine clearance < 80 mL/min)
• Active alcohol or drug abuse
• Uncontrolled diabetes (HgbA1c > 7)
• Current treatment with anti-diabetic medications such as thiazolidinediones or metformin (stable doses of sulfonylureas are acceptable)
• Current treatment with anti-TNF alpha medication (i.e. Remicade or Enbrel)
• Current treatment with vitamin E
• Alcohol consumption < 20 g/day (males) or < 10 g/day (females) - assessed by one physician and confirmed with one family member.
• HIV positive status
• Any history of cerebral and/or retinal hemorrhage
• Prior intolerance of pentoxifylline or any other methylxanthine (i.e. caffeine, theophylline, or theobromine)
• Current use of theophylline
• Known diagnosis of malignancy
• Any other conditions which the investigator feels would make the subject unsuitable for enrollment, or could interfere with the subject completing the protocol

Where it is running

• Northwestern University — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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