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| Tracking Information | |
|---|---|
| First Received Date ICMJE | December 18, 2003 |
| Last Updated Date | December 10, 2007 |
| Start Date ICMJE | |
| Primary Completion Date | |
| Current Primary Outcome Measures ICMJE | |
| Original Primary Outcome Measures ICMJE | |
| Change History | Complete list of historical versions of study NCT00074698 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE | |
| Original Secondary Outcome Measures ICMJE | |
| Descriptive Information | |
| Brief Title ICMJE | Safety and Tolerability Study of FG-3019 in Patients With Idiopathic Pulmonary Fibrosis |
| Official Title ICMJE | A Phase 1 Study of the Safety, Pharmacokinetics, and Biologic Activity of Escalating Doses of FG-3019 in Subjects With Idiopathic Pulmonary Fibrosis |
| Brief Summary | The purpose of this study is to evaluate the safety and tolerability of FG-3019, a therapeutic antibody designed to block the pro-fibrotic activity of connective tissue growth factor (CTGF). CTGF triggers the production of collagen and fibronectin, which cause scarring and thickening of the lungs. Approximately 18 to 27 males and females, 21 to 80 years of age with a diagnosis of idiopathic pulmonary fibrosis (IPF) will be enrolled in this study. The duration of the study is approximately one month, during which patients will receive a single infusion of FG-3019. In addition, there will be two follow-up visits 6 and 12 months after receiving the study drug. |
| Detailed Description | |
| Study Phase | Phase I |
| Study Type ICMJE | Interventional |
| Study Design ICMJE | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
| Condition ICMJE | Idiopathic Pulmonary Fibrosis |
| Intervention ICMJE | Drug: FG-3019 |
| Study Arms / Comparison Groups | |
| Publications * | |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |
| Recruitment Status ICMJE | Completed |
| Enrollment ICMJE | 27 |
| Completion Date | May 2004 |
| Primary Completion Date | |
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
| Gender | Both |
| Ages | 21 Years to 80 Years |
| Accepts Healthy Volunteers | No |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | United States |
| Administrative Information | |
| NCT ID ICMJE | NCT00074698 |
| Responsible Party | |
| Study ID Numbers ICMJE | FGCL-MC3019-002 |
| Study Sponsor ICMJE | FibroGen |
| Collaborators ICMJE | |
| Investigators ICMJE | |
| Information Provided By | FibroGen |
| Verification Date | December 2007 |
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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