Status:
COMPLETED
Safety, Tolerability, and Efficacy Study of Idiopathic Pulmonary Fibrosis
Lead Sponsor:
FibroGen
Conditions:
Idiopathic Pulmonary Fibrosis
Eligibility:
All Genders
35-80 years
Phase:
PHASE2
Brief 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.
Detailed 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) subj...
Eligibility Criteria
Inclusion
- Main
- Age 35 to 80 years, inclusive.
- Clinical diagnosis of IPF by high resolution computed tomography (HRCT) scan (and in some cases by surgical lung biopsy) and reduced lung function (forced vital capacity).
- History of IPF of 5 years duration or less.
- Evidence of progression of IPF within the last 3-12 months for Cohort 1, or within the last 18 months for Cohort 2 before screening.
- Women of childbearing potential, and men, must be willing to use a medically acceptable method of contraception during the trial and 3 months after the last dose of study drug.
- Main
Exclusion
- Women who are pregnant or nursing.
- History of any other types of lung or heart disease and any other medical conditions that, in the opinion of the investigator, would preclude the subject's participation in the study.
- Clinically important abnormal laboratory tests.
- Upper or lower respiratory tract infection of any type within 4 weeks of the first screening visit.
- Acute exacerbation of IPF within 3 months of the first screening visit.
- Use of certain medications within 4 weeks of the first screening visit.
- Receipt of an investigational drug within 6 weeks of the first screening visit.
- History of cancer of any type in the 5 years preceding the first screening visit, excluding non-melanomatous skin cancer, localized bladder cancer, or in situ cervical cancer.
- Trauma or surgical procedures requiring hospitalization within 4 weeks of the first screening visit.
- Planned elective surgery during the study including 4 weeks following the final dose of study drug.
- History of allergic or anaphylactic reaction to human, humanized, chimeric or murine monoclonal antibodies.
- Inability to cooperate with study personnel or history of non-compliance to a medical regimen.
- Previous treatment with FG-3019.
Key Trial Info
Start Date :
March 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 21 2017
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT01262001
Start Date
March 1 2011
End Date
June 21 2017
Last Update
October 9 2019
Active Locations (18)
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1
University of Alabama at Birmingham Hospital
Birmingham, Alabama, United States, 35294
2
Arizona Pulmonary Specialists, LTD
Scottsdale, Arizona, United States, 85258
3
Yale University
New Haven, Connecticut, United States, 06520
4
Central Florida Pulmonary Group, PA
Orlando, Florida, United States, 32803