KCT0006138
Recruiting
未知
A single-arm, open-label, multicenter study to assess molecular response of P1101 therapy in patients with polycythemia vera and elevated hematocrit
ConditionsNeoplasms
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Neoplasms
- Sponsor
- The Catholic University of Korea, Seoul St. Mary's Hospital
- Enrollment
- 93
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.19 years or older
- •2\.Diagnosis of Polycythemia Vera according to the WHO 2016 criteria with the mandatory presence of JAK2V617F mutation as the major disease criterion.
- •3\.Hematocrit \>45%
- •4\.Patients who require cytoreduction treatment
- •5\. Signed written informed consent
Exclusion Criteria
- •1\.Any contraindication to the pegylated interferon, or any systemic exposure to a non\-pegylated or pegylated interferon alpha
- •2\.Documented autoimmune disease at screening or in the medical history
- •3\.Clinically relevant pulmonary infiltrates, pneumonia, and pneumonitis at screening
- •4\.Systemic infections, e.g. hepatitis B, hepatitis C, or HIV at screening
- •5\.Known PV\-related thromboembolic complications in the abdominal area (e.g. portal vein thrombosis, Budd\-chiari syndrome) and/or splenectomy in the medical history
- •6\.Any investigational drug less than 6 weeks prior to the first dose of study drug or not recovered from effects of prior administration of any investigational agent
- •7\. History or presence of depression requiring treatment with antidepressant
- •8\.Any risk of suicide at screening or previous suicide attempts
- •9\.Any significant morbidity or abnormality which may interfere with the study participation
- •10\.Pregnancy and breast\-feeding females of reproductive potential and males not using effective means of contraception
Outcomes
Primary Outcomes
Not specified
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