Clareo Health | Study of Efficacy and Safety in Polycythemia Vera Subjects Who Are Resistant to or Intolerant of Hydroxyurea: JAK Inhibitor INC424 (INCB018424) Tablets Versus Best Available Care: (The RESPONSE Trial)
Study of Efficacy and Safety in Polycythemia Vera Subjects Who Are Resistant to or Intolerant of Hydroxyurea: JAK Inhibitor INC424 (INCB018424) Tablets Versus Best Available Care: (The RESPONSE Trial)
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Incyte Corporation
With
Novartis Pharmaceuticals
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Participants diagnosed with PV for at least 24 weeks prior to screening according to the 2008 World Health Organization criteria
Participants resistant to or intolerant of hydroxyurea
Participants with a phlebotomy requirement
Participants with splenomegaly (palpable or non-palpable) and a spleen volume, as measured by MRI (or CT in applicable participants ), of greater than or equal to 450 cubic centimeters
Participants with an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
You may not be if
Women who are pregnant or nursing
Participants with inadequate liver or renal function
Participants with significant bacterial, fungal, parasitic, or viral infection requiring treatment
Participants with an active malignancy within the past 5 years, excluding specific skin cancers
Participants with known active hepatitis or HIV positivity
Participants who have previously received treatment with a JAK inhibitor
Participants being treated with any investigational agent
