Phase 3 N=26 Randomized Double-blind Treatment

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

Nonalcoholic Steatohepatitis · Liver Diseases

Bottom Line

View on ClinicalTrials.gov: NCT00267670 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Sep 2014

Primary outcome: Primary: The Number of Participants With a 30% Reduction in Alanine Aminotransferase (ALT) Treated With Pentoxifylline (PTX) or Placebo for 12 Months. — 19; 7 participants — p=0.46

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Pentoxifylline (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Northwestern University
Primary completion: Sep 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY The Number of Participants With a 30% Reduction in Alanine Aminotransferase (ALT) Treated With Pentoxifylline (PTX) or Placebo for 12 Months.	19; 7	0.46
SECONDARY The Effect of Pentoxifylline on Change in Tumor Necrosis Factor [TNF]-α Levels in Patients With NASH	-117.9; 18.3	0.16
SECONDARY Change in Serum Leptin Levels in Patients Treated With Pentoxifylline or Placebo for 12 Months	0.78; 0.78	0.94
SECONDARY Change in Serum Adiponectin Levels in Patients Treated With Pentoxifylline or Placebo for 12 Months	0.4; 0.8	0.49

Summary

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

Eligibility Criteria

Inclusion Criteria

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 3.2 g/dL
Serum creatinine within normal limits
Hemoglobin A1c (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

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Data sourced from ClinicalTrials.gov (NCT00267670). 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.