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Safety, Tolerability, and Efficacy Study of Idiopathic Pulmonary Fibrosis

NCT01262001 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2019-10-09

No results posted yet for this study

Summary

To evaluate the safety and tolerability of FG-3019 in subjects with Idiopathic Pulmonary Fibrosis (IPF) and the efficacy of FG-3019 for attenuating fibrosis in these subjects.

Conditions

Interventions

DRUG

FG-3019

Cohort 1 and Cohort 1-EX: 15 mg/kg by infusion every 3 weeks for 45 weeks in the target population (first treatment year and first extended treatment year and every 3 weeks thereafter for three additional extended treatment years).

DRUG

FG-3019

Cohort 2 and Cohort 2-EX: 30 mg/kg by infusion every 3 weeks for 45 weeks in the target population (first treatment year and first extended treatment year and every 3 weeks thereafter for three additional extended treatment years).

Sponsors & Collaborators

  • FibroGen

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-03-31
Primary Completion
2014-06-26
Completion
2017-06-21

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT01262001 on ClinicalTrials.gov