Polycythemia Vera (PV)
Randomized Switch Study from Hydroxyurea to Ruxolitinib for RELIEF of Polycythemia Vera Symptoms: The Relief Study
Incyte Study ID:
18424-357
CT.gov ID:
Eudra ID:
N/A
Sponsor:
Incyte Corporation
Collaborator:
N/A
Study Contact Information:
Study Complete
Clinical Study Purpose
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.
Clinical Study Summary
MEDICAL CONDITION(S)
PRODUCT
COLLABORATORS
N/A
DATE
Jun 2012 - Mar 2014
TYPE
Interventional
PHASE
Phase 3
SEX
Female & Male
AGE
18+ years
ACCEPTS HEALTHY VOLUNTEERS
No
Key Inclusion and Exclusion Criteria
Inclusion Criteria
- Subjects must currently be reporting symptoms while on a stable dose of HU monotherapy and be eligible to continue HU on study after randomization.
- Before screening, the subject must have been receiving HU for at least 12 weeks AND be receiving a stable dose.
Exclusion Criteria
- Subjects with inadequate liver or renal function at screening.
- Subjects with clinically significant infection that requires therapy
Clinical Study Locations
Location
Status
Location
Scottsdale, AZ, US
Status
Recruiting
Location
Fayetteville, AR, US
Status
Recruiting
Location
Burbank, CA, US
Status
Recruiting
Location
Glendale, CA, US
Status
Recruiting
Location
La Jolla, CA, US
Status
Recruiting
Location
Los Angeles, CA, US
Status
Recruiting
Protocol Summary
Incyte Study ID:
18424-357
Primary Purpose:
Treatment
Allocation:
Randomized
Study Design:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Interventions:
Drug
Enrollment:
110
Primary Outcome
Open
Secondary Outcome
Open