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Safety, Tolerability, and Efficacy Study of Idiopathic Pulmonary Fibrosis — FGCL-3019-049  

Idiopathic Pulmonary Fibrosis Clinical Trial

Official title:
A Phase 2, Open-Label, Dose-Escalation Study to Evaluate the Safety, Tolerability, and Efficacy of FG-3019 in Subjects With Idiopathic Pulmonary Fibrosis

Clinical Trial 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.

Clinical Trial Description

Major Changes: FGCL-3019-049 Protocol Amendment 3 offers long-term extension of treatment with FG-3019 to eligible Cohort 1-EX (approximately 14 subjects) and Cohort 2 (approximately 28 subjects) subjects who complete the Week 48-EX and Week 48 assessments described in Protocol Amendment 2, respectively. A subject is eligible for long-term extension of treatment if the investigator, after discussion with the Fibrogen Medical Monitor, believes that the subject would benefit from continued treatment with FG-3019. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01262001
Study type Interventional
Source FibroGen
Contact
Status Completed
Phase Phase 2
Start date March 2011
Completion date June 21, 2017
View Details
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