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Simtuzumab (SIM, GS-6624) in the Treatment of Cirrhosis Due to NASH

NCT01672879 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 259

Last updated 2019-03-27

Study results available
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Summary

The primary objective of this study is to evaluate the safety and efficacy of SIM (formerly referred to as GS-6624) in adults with compensated cirrhosis due to Non-Alcoholic Steatohepatitis (NASH). It will consist of 2 phases:

* Randomized Double-Blind Phase
* Open-Label Phase (optional)

Conditions

  • Liver Fibrosis Due to NASH

Interventions

BIOLOGICAL

Placebo

Placebo to match SIM intravenous infusion over 30 minutes every 2 weeks

BIOLOGICAL

SIM

Intravenous infusion over 30 minutes every 2 weeks

Sponsors & Collaborators

Principal Investigators

  • Gilead Study Director · Gilead Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2012-10-29
Primary Completion
2016-09-26
Completion
2017-01-03
FDA Drug
Yes

Countries

  • United States
  • Canada
  • France
  • Germany
  • Italy
  • Puerto Rico
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

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 NCT01672879 on ClinicalTrials.gov