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NCT01452308 · ClinicalTrials.gov registry record · Phase 2
Pilot Study of Simtuzumab in the Treatment of Liver Fibrosis
A Phase 2 study of Liver Fibrosis, sponsored by Gilead Sciences.
- Completed
- Registry status
- Phase 2
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT01452308 is a Phase 2 study of Liver Fibrosis that has completed, run by Gilead Sciences. The registered enrollment target is 20 participants, below the 371-participant average among 11 other Liver Fibrosis trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state.
The verdict
NCT01452308, a Phase 2 study of Liver Fibrosis, has completed, sponsored by Gilead Sciences.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study Summary
This study will evaluate the safety and tolerability of simtuzumab (GS-6624) in patients with fibrosis of the liver. Up to 20 participants will be enrolled into two sequential cohorts. Cohort 1 will consist of 10 participants who will receive simtuzumab every other week for a total of 3 infusions. Participants in Cohort 2 (10 subjects) will also receive simtuzumab every other week for a total of 3 infusions; the dose will depend on the safety and tolerability of simtuzumab seen in Cohort 1. Participants from both cohorts who have completed the main study will be allowed to continue on simtuzumab treatment for an additional extension period, and will receive up to 13 additional infusions of simtuzumab at a fixed dose of 700 mg for an additional 24 weeks.
Conditions Studied
Interventions
- BIOLOGICAL Simtuzumab
Study Locations (1)
New York
- Weill Cornell Medical College: NewYork-Presbyterian Hospital - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2011-11 |
| Est. Completion | 2013-08 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01452308
The ClinicalTrials.gov registry entry for NCT01452308 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 371-participant average among 11 other Liver Fibrosis trials with a reported enrollment target (95% lower). The listed sponsor is Gilead Sciences, which has 504 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Liver Fibrosis appearing as the primary indexed condition, and to 1 intervention - of which Simtuzumab is the first listed.
NCT01452308 reports 1 study location spanning 1 distinct geographic area - top geographies include New York.
Frequently Asked Questions
What is clinical trial NCT01452308 about?
NCT01452308 is a clinical study titled "Pilot Study of Simtuzumab in the Treatment of Liver Fibrosis". This study will evaluate the safety and tolerability of simtuzumab (GS-6624) in patients with fibrosis of the liver. Up to 20 participants will be enrolled into two sequential cohorts. Cohort 1 will consist of 10 participants who will receive simtuzumab every other week for a total of 3 infusions. ...
What is the current status of trial NCT01452308?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2011-11. Estimated completion is 2013-08.
What conditions does trial NCT01452308 study?
This clinical trial studies the following conditions: Liver Fibrosis.
What interventions are being tested in trial NCT01452308?
The interventions under investigation include: Simtuzumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT01452308?
This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01452308 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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