Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01362231 | A Study to Evaluate the Safety and Efficacy of GS-6624 (Formerly AB0024) in Patients With Idiopathic Pulmonary Fibrosis | PHASE1 | COMPLETED | 48 | — | — | Dec 1, 2010 | Dec 1, 2012 | Jul 9, 2015 | 7 | United States |
To characterize the safety, tolerability, and pharmacokinetics (PK) of GS-6624 after multiple intravenous (IV) administrations in subjects with idiopathic pulmonary fibrosis (IPF).
| Arm | Type | Description |
|---|---|---|
| GS-6624 125mg | EXPERIMENTAL | - |
| Experimental: GS-6624 200mg | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| GS-6624 | DRUG | Patients will be treated with GS-6624 (125 or 200 mg) administered IV over 1 hour on specific days during the treatment period. |
Inclusion Criteria: 1. Acceptable results on pulmonary function tests 2. At rest oxygen saturation ≥90% on room air 3. Adequate organ function Exclusion Criteria: 1. High resolution computer tomography pattern showing emphysema that is greater than fibrosis 2. Acceptable results on whole body ple...
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