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NCT01769196 · ClinicalTrials.gov registry record · Phase 2
Study to Assess the Efficacy and Safety of Simtuzumab (GS-6624) in Adults With Idiopathic Pulmonary Fibrosis (IPF)
A Phase 2 study, sponsored by Gilead Sciences.
- Terminated
- Registry status
- Phase 2
- Development phase
- 544
- Enrollment target
NCT01769196: Clinical Trial Phase 2 study, sponsored by Gilead Sciences.
NCT01769196 is a Phase 2 study that was terminated before completion, run by Gilead Sciences. The registered enrollment target is 544 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (309% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01769196, a Phase 2 study, was terminated before completion, sponsored by Gilead Sciences.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 544 participants
- Enrollment target
Study Summary
The primary objectives of this study are to determine the effect of simtuzumab (GS-6624) on progression-free survival (PFS) as determined by either a categorical decline in forced vital capacity (FVC) or all-cause mortality, in all participants enrolled or in a subset of participants who are classified as lysyl oxidase-like-2 (LOXL2) high based on a prespecified level in serum at baseline.
Primary Outcome
Progression free survival (PFS) was defined as the categorical decrease in forced vital capacity (FVC) % predicted (≥ 10% relative decrease in FVC and ≥ 5% absolute decrease in FVC from baseline) with confirmation at a consecutive visit at least 2 weeks later using the same criteria.
Interventions
- DRUG Simtuzumab
- DRUG Simtuzumab placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 544 participants |
| Start Date | 2013-01-31 |
| Est. Completion | 2016-02-23 |
| Phase | Phase 2 |
Why NCT01769196 stopped before completion
NCT01769196 is an interventional study that assigns participants to a tested intervention. The registered 544 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (309% higher).
The record links to 0 conditions, and to 2 interventions - of which Simtuzumab is the first listed.
NCT01769196 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01769196 about?
NCT01769196 is a clinical study titled "Study to Assess the Efficacy and Safety of Simtuzumab (GS-6624) in Adults With Idiopathic Pulmonary Fibrosis (IPF)". The primary objectives of this study are to determine the effect of simtuzumab (GS-6624) on progression-free survival (PFS) as determined by either a categorical decline in forced vital capacity (FVC) or all-cause mortality, in all participants enrolled or in a subset of participants who are classif...
What is the current status of trial NCT01769196?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 544 participants. The study started on 2013-01-31. Estimated completion is 2016-02-23.
What interventions are being tested in trial NCT01769196?
The interventions under investigation include: Simtuzumab (DRUG), Simtuzumab placebo (DRUG).
Who is sponsoring clinical trial NCT01769196?
This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01769196's enrollment target sits among peer trials
544 62nd of 2000 higher than 1,939 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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