Pentoxifylline and Metformin versus Placebo for The Treatment of Patients with Nonalcoholic steatohepatitis, A Randomized, Double-Blinded, Placebo- Controlled Clinical Trial.

Phase 2

Recruiting

• Conditions: onalcoholic steatohepatitis; NASH; Pentoxifylline; Metformin; Fibroscan™ (Transient elastography)

• Registration Number: TCTR20130528001
• Lead Sponsor: The Gastroenterological Association of Thailand

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2013-03-01
• Study Start: 2013-05-28
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 38

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
afld activity score 48 weeks liver biopsy

Secondary Outcome Measures

Name	Time	Method
liver stiffness 24 weeks and 48 weeks fibroscan,liver fibrosis score 24 weeks and 48 weeks liver fibrosis score,liver enzyme 24 weeks and 48 weeks AST/ALT