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NCT01632904 · ClinicalTrials.gov registry record · Phase 3

Randomized Switch Study From Hydroxyurea to Ruxolitinib for RELIEF of Polycythemia Vera Symptoms: The Relief Study

A Phase 3 study, sponsored by Incyte Corporation.

Completed
Registry status
Phase 3
Development phase
110
Enrollment target

NCT01632904 is a Phase 3 study that has completed, run by Incyte Corporation. The registered enrollment target is 110 participants.

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The verdict

NCT01632904, a Phase 3 study, has completed, sponsored by Incyte Corporation.

COMPLETED
Registry status
Phase 3
Development phase
110 participants
Enrollment target

Study Summary

The purpose of the RELIEF study is to compare symptoms in polycythemia vera (PV) subjects treated with ruxolitinib versus subjects treated with hydroxyurea (HU) as measured by the percent of subjects who achieve a clinically meaningful symptom improvement (ie, total symptom score reduction of ≥ 50% reduction) at Week 16 compared to Baseline. The study is also designed to demonstrate that these responses are durable with continued treatment.

Interventions

  • DRUG Ruxolitinib
  • DRUG Hydroxyurea (HU)
  • DRUG HU-placebo
  • DRUG Ruxolitinib-placebo

Trial Details

FieldValue
Enrollment Target 110 participants
Start Date 2012-06
Est. Completion 2016-05
Phase Phase 3

Sponsor

Incyte Corporation

239 total trials

What the Registry Record Tells You About NCT01632904

The ClinicalTrials.gov registry entry for NCT01632904 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 110 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Incyte Corporation, which has 239 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 4 interventions - of which Ruxolitinib is the first listed.

NCT01632904 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01632904 about?

NCT01632904 is a clinical study titled "Randomized Switch Study From Hydroxyurea to Ruxolitinib for RELIEF of Polycythemia Vera Symptoms: The Relief Study". The purpose of the RELIEF study is to compare symptoms in polycythemia vera (PV) subjects treated with ruxolitinib versus subjects treated with hydroxyurea (HU) as measured by the percent of subjects who achieve a clinically meaningful symptom improvement (ie, total symptom score reduction of ≥ 50% ...

What is the current status of trial NCT01632904?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 110 participants. The study started on 2012-06. Estimated completion is 2016-05.

What interventions are being tested in trial NCT01632904?

The interventions under investigation include: Ruxolitinib (DRUG), Hydroxyurea (HU) (DRUG), HU-placebo (DRUG), Ruxolitinib-placebo (DRUG).

Who is sponsoring clinical trial NCT01632904?

This trial is sponsored by Incyte Corporation, which has 239 total clinical trials registered on ClinicalTrials.gov.

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

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.