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A Study to Assess Efficacy, Safety, and Tolerability of P1101 in Adult Patients with PV
Full description
Polycythemia vera (PV) is the most common type of chronic myeloproliferative neoplasm (MPN), with an annual reported incidence of up to 2.6/100,000. This is a long-term debilitating and life-threatening disease because it is associated with the risk of thrombosis, bleeding, and progression to myelofibrosis (MF) and secondary acute myeloid leukemia (sAML)
Ropeginterferon alfa-2b-njft (P1101), which gained US marketing authorization in November 2021, is the only interferon alfa approved for the treatment of PV.
This study aims to evaluate the efficacy, tolerability, and safety of ropeginterferon alfa-2b-njft (P1101) in US and Canadian PV patients, utilizing an optimized dosing regimen.
Enrollment
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Inclusion criteria
Exclusion criteria
Any contraindications to interferon alfa or hypersensitivity to interferon alfa
Subjects who stopped prior to interferon alfa therapy due to low efficacy or poor tolerability
Subjects with severe or serious diseases that the Investigator determines may affect the subject's participation in this study
History of major organ transplantation
Pregnant or breastfeeding women
Subjects with any other diseases that the Investigator determines will affect the study results or may weaken the compliance to protocol, including but not limited to:
Use any investigational drug <4 weeks prior to the first dose of study drug, or not recovered from effects of prior administration of any investigational drug
Any subject requiring a legally authorized representative
Primary purpose
Allocation
Interventional model
Masking
100 participants in 2 patient groups
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Central trial contact
Jewell Jessup, PhD
Data sourced from clinicaltrials.gov
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