Phase 1 Study to Evaluate Safety of GR-MD-02 in Subjects With Non-Alcoholic Steatohepatitis (NASH) and Advanced Fibrosis

Non-Alcoholic Steatohepatitis (NASH) Clinical Trial

Official title: A Multi-Center, Partially Blinded, Maximum Tolerated Multiple Dose Escalation, Phase 1 Clinical Trial to Evaluate the Safety of GR-MD-02 in Subjects With Non-Alcoholic Steatohepatitis (NASH)With Advanced Hepatic Fibrosis

Status Completed

Clinical Trial Summary

The primary objective of this study is to characterize the safety, tolerability and dose-limiting toxicities (DLTs) for GR-MD-02 when administered intravenously to subjects with biopsy-proven NASH with advanced liver fibrosis.

Clinical Trial Description

This study is a dose ranging study to assess in sequential fashion, the safety, tolerability, and dose limiting toxicities (DLTs) of GR-MD-02, in subjects with biopsy-proven NASH with advanced fibrosis. This is a dose escalation design comprised of 3 sequential cohorts to evaluate the safety of GR MD 02 when administered as a single IV infusion followed by 3 additional weekly infusions starting 28 days after the first dose. Each cohort will consist of 8 subjects, 6 randomized to receive active drug and 2 randomized to receive placebo.Based on data safety monitoring board (DSMB) and FDA review, 2 additional cohorts may be implemented, consisting of 8 subjects. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fatty Liver
• Non-Alcoholic Steatohepatitis (NASH)

• NCT number: NCT01899859
• Study type: Interventional
• Source: Galectin Therapeutics Inc.
• Status: Completed
• Phase: Phase 1
• Start date: July 2013
• Completion date: February 2015