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NCT01369498 · ClinicalTrials.gov registry record · Phase 2
Efficacy and Safety of Simtuzumab in Adults With Primary, Post Polycythemia Vera or Post Essential Thrombocythemia Myelofibrosis
A Phase 2 study, sponsored by Gilead Sciences.
- Completed
- Registry status
- Phase 2
- Development phase
- 54
- Enrollment target
NCT01369498 is a Phase 2 study that has completed, run by Gilead Sciences. The registered enrollment target is 54 participants.
The verdict
NCT01369498, a Phase 2 study, has completed, sponsored by Gilead Sciences.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 54 participants
- Enrollment target
Study Summary
This study is to evaluate the efficacy and safety of simtuzumab (GS-6624) on bone marrow fibrosis either alone or in combination with ruxolitinib in participants with primary myelofibrosis (PMF) and post polycythemia vera or post essential thrombocythemia myelofibrosis (ET/PV MF). The study is designed as a two-stage trial. In the stage 1, participants will be randomized into two cohorts to receive either 200 or 700 mg of study drug. In the stage 2, participants on ruxolitinib will be randomized to receive either 200 or 700 mg of study drug.
Interventions
- DRUG Ruxolitinib
- DRUG Simtuzumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 54 participants |
| Start Date | 2011-06-30 |
| Est. Completion | 2014-09-24 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01369498
The ClinicalTrials.gov registry entry for NCT01369498 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 54 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Gilead Sciences, which has 504 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Ruxolitinib is the first listed.
NCT01369498 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01369498 about?
NCT01369498 is a clinical study titled "Efficacy and Safety of Simtuzumab in Adults With Primary, Post Polycythemia Vera or Post Essential Thrombocythemia Myelofibrosis". This study is to evaluate the efficacy and safety of simtuzumab (GS-6624) on bone marrow fibrosis either alone or in combination with ruxolitinib in participants with primary myelofibrosis (PMF) and post polycythemia vera or post essential thrombocythemia myelofibrosis (ET/PV MF). The study is desi...
What is the current status of trial NCT01369498?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 54 participants. The study started on 2011-06-30. Estimated completion is 2014-09-24.
What interventions are being tested in trial NCT01369498?
The interventions under investigation include: Ruxolitinib (DRUG), Simtuzumab (DRUG).
Who is sponsoring clinical trial NCT01369498?
This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.
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