Status:
COMPLETED
Study of GC1008 in Patients With Idiopathic Pulmonary Fibrosis (IPF)
Lead Sponsor:
Genzyme, a Sanofi Company
Conditions:
Idiopathic Pulmonary Fibrosis
Eligibility:
All Genders
18-79 years
Phase:
PHASE1
Brief Summary
This study is designed to investigate whether GC1008, an antibody that neutralizes TGFb, is safe in treating patients with idiopathic pulmonary fibrosis. The highest dose without excessive side effect...
Eligibility Criteria
Inclusion
- Willing and able to provide written informed consent prior to any study-related procedures.
- Patients should have an established diagnosis of IPF.
- Pulmonary Function Tests (PFTs): FVC ≥ 50% and DLCO ≥ 25% of normal predicted values.
- Able to walk at least 500 feet (150 meters) during the 6-minute Walk Test (6MWT). During the 6MWT the patient must not require greater than 51/min supplemental oxygen to maintain oxygen saturation \> 80%
Exclusion
- Women who are pregnant or lactating; or who plan to become pregnant within 9 months after the infusion.
- Women of childbearing potential or men who are considering fathering a child unless taking medically acceptable contraceptive precautions;
- History of clinically significant environmental exposure, including dust, molds, asbestos, pigeons or other birds that may result in interstitial lung disease, or ingestion of a drug known to cause pulmonary fibrosis such as bleomycin.
- History of clinically significant respiratory diseases other than IPF.
- History of clinically significant cardiac, hepatic, or renal disease.
- History of cancer, precancerous state (e.g. familial polyposis, BRCA1, BRCA2), other than non-melanomatous skin cancer, within 5 years prior to Screening.
- Use of any investigational drug administered as part of a clinical trial within 12 weeks before Screening.
- Other pathology that might interfere with the assessment of the safety or efficacy of the test article.
- Other clinically significant, uncontrolled medical condition that, in the Investigator's opinion, might interfere with the assessment or follow-up.
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2008
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00125385
Start Date
July 1 2005
End Date
September 1 2008
Last Update
April 13 2015
Active Locations (8)
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1
Denver, Colorado, United States, 80206
2
Chicago, Illinois, United States, 60637
3
Ann Arbor, Michigan, United States, 48109
4
Minneapolis, Minnesota, United States