Pioglitazone vs Vitamin E vs Placebo for Treatment of Non-Diabetic Patients With Nonalcoholic Steatohepatitis (PIVENS)

National Institutes of Health (NIH)

Status and phase: Completed; Phase 3

Conditions: Liver Diseases

Treatments: Drug: Pioglitazone; Drug: Matching placebo; Dietary Supplement: Vitamin E

Study type: Interventional

Funder types: NIH

Identifiers

NCT00063622

U01DK061730 (U.S. NIH Grant/Contract)

NASH - ADULT (IND)

Details and patient eligibility

About

The purpose of this study is to determine if therapy with pioglitazone or vitamin E will lead to an improvement in liver histology in non-diabetic adult patients with non-alcoholic steatohepatitis (NASH).

Full description

The purpose of this study is to determine if therapy with pioglitazone or vitamin E will lead to an improvement in liver histology in non-diabetic adult patients with non-alcoholic steatohepatitis (NASH).

Enrollment: 247 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

• Histologic evidence of NASH based on a liver biopsy obtained within 6 months of randomization.
• Age 18 years or older

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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247 participants in 3 patient groups, including a placebo group

1

Active Comparator group

Description:

Pioglitazone

Treatment:

Drug: Pioglitazone

2

Active Comparator group

Description:

Vitamin E

Treatment:

Dietary Supplement: Vitamin E

3

Placebo Comparator group

Description:

Placebo Pioglitazone or Placebo Vitamin E

Treatment:

Drug: Matching placebo