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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.

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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

FieldValue
Enrollment Target 54 participants
Start Date 2011-06-30
Est. Completion 2014-09-24
Phase Phase 2

Sponsor

Gilead Sciences

504 total trials

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.