TCTR20130528001RecruitingPhase 2
Pentoxifylline and Metformin versus Placebo for The Treatment of Patients with Nonalcoholic steatohepatitis, A Randomized, Double-Blinded, Placebo- Controlled Clinical Trial.
The Gastroenterological Association of Thailand0 sites38 target enrollmentStarted: May 28, 2013Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Enrollment
- 38
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 Years to 70 Years (—)
- Sex
- All
Inclusion Criteria
- •1. biopsy proven NASH performed within 2 year of entry
- •2. ALT > 1.5 times of ULN and repeated at least twice over 6 months
- •3. life style modification in the outpatient clinic for up to 3 months and persistent ALT elevation
- •4. Not taking metformin or PTX at least 3 month prior to entry
- •5. type 2 DM Patients included only if on oral hypoglycemic drug and with hemoglobin A1C <8%
Exclusion Criteria
- •1. Alcohol intake > 20gm/day in men and 10 gm/day in women for 2 years
- •Other chronic liver diseases
- •2. Decompensated cirrhosis
- •3. Secondary steatohepatitis e.g. drug
- •(tamoxifen, methotrexate, amiodarone, valproate, glucocorticoid)
- •4. Taking medications that have shown benefits in previous NASH studies e.g. pioglitazone, Vitamin E, Folic acid, UDCA, Omega 3, NAC
- •Cr > 1.5mg/dl
- •5. A history of drug allergy to PTX or methylxanthines (caffeine, theophylline) and metformin
- •6. Risk of bleeding tendency
- •7. Pregnancy
- •8. Refuse Liver biopsy
Investigators
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