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

NCT01899859 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2015-02-23

No results posted yet for this study

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.

Conditions

  • Non-Alcoholic Steatohepatitis (NASH)

Interventions

DRUG

GR-MD-02

GR-MD-02; galactoarabino-rhamnogalaturonate

DRUG

Placebo

GR-MD-02 Placebo

Sponsors & Collaborators

  • Galectin Therapeutics Inc.

    lead INDUSTRY

Principal Investigators

  • Stephen Harrison, MD · Brooke Army Medical Center

  • Naga Chalasani, MD · Indiana University School of Medicine

  • Ram Subramanian, MD · Emory University Hospital (Transplant Center Clinical Research)

  • Thomas Schiano, MD · The Mount Sinai Medical Center (Division of Liver Diseases)

  • Brent A Tetri, MD · St. Louis University School of Medicine

  • Mohammad S Siddiqui, MD · Virginia Commonwealth University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
74 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-07-31
Primary Completion
2015-02-28
Completion
2015-02-28

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01899859 on ClinicalTrials.gov