Trial intelligence / Profile preview

Hepar-P in Non-alcoholic Fatty Liver Disease

NCT01680003Phase 2

Key facts

Status: Unknown
Start: Sep 2012
Primary completion: Oct 2013
Countries: 1
Sponsor: Nova Laboratories
Modality: Small Molecules

Drugs: hepar-p
Conditions: non-alcoholic fatty liver disease (NAFLD)

Overview

Phase 2, randomised, double-blind trial in non-alcoholic fatty liver disease (NAFLD) comparing Hepar-P with Placebo (2 arms). Primary endpoints: Aspartate Aminotransferase at 48 weeks and Alanine Aminotransferase at 48 weeks. Status: unknown.

Design

2 arms

Study design: RandomizedDouble-blind

Hepar-P
Two capsules (250mg x 2), three times daily, orally
Placebo
Two capsules, three times daily, orally

Who it enrols

Adults with biopsy-confirmed steatohepatitis (NAS >=3 or >=5) and elevated AST/ALT levels (<2.5x ULN).

Endpoints

Primary

Aspartate Aminotransferase48 weeks
Alanine Aminotransferase48 weeks

Secondary

Degree of Steatosis48 weeks
Lobular Inflammation48 weeks
Hepatocellular Ballooning48 weeks
Fibrosis48 weeks
NAFLD Activity Score48 weeks

Beyond the preview

Go deeper on NCT01680003.

Full results, competitive context and analysis are in the Gosset platform.

Full results & analysis

Available in the Gosset platform where reported.

Competitive context

Available in the Gosset platform where reported.

Bring the full picture into focus.

See how Gosset can support your research on NCT01680003.