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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: Completed Phase 2 study of Liver Fibrosis, sponsored by Gilead Sciences.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The endpoints to be evaluated will include graded Adverse Events, laboratory abnormalities, and vital sign measurements
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 |
What the finished NCT01452308 record still lists
NCT01452308 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 371-participant average among 11 other Liver Fibrosis trials with a reported enrollment target (95% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Liver Fibrosis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01452308's enrollment target sits among peer trials
20 10th of 11 higher than 2 of 11 other Liver Fibrosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Liver Fibrosis 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.
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