Ignite Creation Date:
2025-12-24 @ 7:51 PM
Ignite Modification Date:
2025-12-28 @ 11:58 AM
Study NCT ID:
NCT01632904
Status:
COMPLETED
Last Update Posted:
2017-11-14
First Post:
2012-06-29
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Randomized Switch Study From Hydroxyurea to Ruxolitinib for RELIEF of Polycythemia Vera Symptoms: The Relief Study
Sponsor:
Incyte Corporation
Organization:
Study Overview
Official Title:
Polycythemia Vera Symptom Study Evaluating Ruxolitinib Versus Hydroxyurea in a Randomized, Multicenter, Double-Blind, Double-Dummy, Phase 3 Efficacy and Safety Study of Patient Reported Outcomes
Status:
COMPLETED
Status Verified Date:
2017-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed Description:
This is a Phase 3 multicenter, double-blind, double-dummy, randomized study. Only subjects with PV who have received HU for at least 12 weeks, have been receiving a stable dose before screening, and still have symptoms related to PV will be enrolled.
Subjects will be randomized (1:1) to 1 of 2 treatment arms:
A: ruxolitinib and HU-placebo B: HU and ruxolitinib-placebo
Subjects randomized to either arm may be eligible to transition to open-label ruxolitinib after Week 16.
Subjects will be randomized (1:1) to 1 of 2 treatment arms:
A: ruxolitinib and HU-placebo B: HU and ruxolitinib-placebo
Subjects randomized to either arm may be eligible to transition to open-label ruxolitinib after Week 16.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: