None listed
Conditions
Interventions
Drug : P1101 is administered subcutaneously every 2 weeks at a starting dose of 250 µg (escalating to 500 µg). Subjects may receive up to 48 weeks of treatment with P1101
Sponsors
The Catholic University of Korea, Seoul St. Mary's Hospital
Eligibility
Sex/Gender
All
Inclusion 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
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 11. History of active substance or alcohol abuse within the last year 12. Evidence of severe retinopathy (e.g. cytomegalovirus retinitis, macular degeneration) or clinically relevant ophthalmological disorder (due to diabetes mellitus or hypertension) 13. Thyroid dysfunction not adequately controlled 14. History of major organ transplantation 15. History of uncontrolled severe seizure disorder 16. Leukocytopenia at the time of screening 17. Thrombocytopenia at the time of screening 18. History of malignant disease, including solid tumours and hematological malignancies (except Stage 0 chronic lymphocytic leukemia, basal cell, squamous cell, and superficial melanoma) within the last 3 years 19. Subjects who was judged by the investigator as not suitable for participation in this clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate association between P1101’s efficacy and association with molecular response (as assessed by reduction in JAK2 Val617Phe allele burden) | — |
Secondary
| Measure | Time frame |
|---|---|
| - To estimate P1101’s efficacy. - To examine time to disease response, disease response duration. - To evaluate the safety of ropeginterferon alfa-2b | — |
Countries
Korea, Republic of
Contacts
Public ContactSung-Eun Lee
The Catholic University of Korea, Seoul St. Mary's Hospital
Outcome results
None listed