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Simtuzumab (GS-6624) in the Prevention of Progression of Liver Fibrosis in Adults With Primary Sclerosing Cholangitis (PSC)

NCT01672853 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 235

Last updated 2019-10-22

Study results available
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Summary

The purpose of this study is to evaluate whether simtuzumab (GS-6624) is effective at preventing the progression of liver fibrosis in adults with primary sclerosing cholangitis (PSC).

Conditions

  • Primary Sclerosing Cholangitis (PSC)

Interventions

BIOLOGICAL

Simtuzumab

Subcutaneous injections weekly for a total of 96 injections

BIOLOGICAL

Placebo

Subcutaneous injections weekly for a total of 96 injections

Sponsors & Collaborators

Principal Investigators

  • Gilead Study Director · Gilead Sciences

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2013-03-04
Primary Completion
2016-08-08
Completion
2016-08-24
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Canada
  • Denmark
  • Germany
  • Italy
  • Netherlands
  • Spain
  • Sweden
  • 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 NCT01672853 on ClinicalTrials.gov