A Study of Rusfertide in Japanese Adults With Polycythemia Vera
ConditionPolycythemia Vera
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorTakeda
About this trial
Polycythemia vera (PV) is a rare blood cancer in which the body makes too many red blood cells. This can make the blood thicker and may increase the risk of serious health problems such as blood clots. Many people with PV need regular phlebotomy, which is a procedure to remove blood, to help keep their hematocrit level under control. Hematocrit is the proportion of red blood cells in the blood.
The main aim of this study is to evaluate whether rusfertide helps Japanese participants with PV keep their hematocrit under control and avoid the need for phlebotomy. All participants in this study will receive rusfertide. This study is open-label, which means both the participants and the study team will know what treatment is being given.
Participants will be followed for up to about 244 weeks, including a screening period, a 52-week initial treatment period, a long-term extension period, and a 4-week safety follow-up period.
Eligibility criteria
Qualifiers
Japanese male and female participants aged 18 years or older at the time of signing informed consent.
Participant understands the trial procedures, is willing and able to adhere to trial requirements and agrees to participate in the trial by giving written informed consent.
Meet revised 2016 WHO criteria for the diagnosis of PV.
At least 3 phlebotomies due to inadequate hematocrit control in 28 weeks before trial intervention or at least 5 phlebotomies due to inadequate hematocrit control in 1 year before trial intervention, and
Disqualifiers
eGFR <15 mL/min/1.73 m² as determined by Japanese Society of Nephrology. Calculated by the correction formula for Japanese*
ALT or AST ≥2.5×ULN
Total bilirubin >1.5×ULN. Note: Screening laboratory tests with abnormal results (if considered by the investigator to be transient and inconsistent with the participant's clinical condition) may be repeated within the screening window to confirm abnormal results. If results return to protocol acceptable limits within the screening period, the participant may enter the trial. Use local labs for all eligibility lab tests.
Participants who require phlebotomy at hematocrit levels lower than 45%.
Trial design
Treatments tested in this trial
- Rusfertide
Treatment groups
9 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Source ClinicalTrials.gov