PharmaEssentia is the sponsor.
This study is designed to assess the effectiveness and safety of two dosing regimens of ropeginterferon alfa-2b-njft (an accelerated titrated dosing versus the current recommended dosing) in adults with polycythemia vera (PV).
Summary:
ECLIPSE PV (NCT05481151) is a Phase 3b clinical research study assessing the effectiveness and safety of two dosing regimens of ropeginterferon alfa-2b-njft (an accelerated titrated dosing versus the current recommended dosing) in adults with PV who are not refractory or intolerant to interferon treatment.
The study will include a 4-week screening period to collect medical history and confirm eligibility to receive treatment, a 6-month core treatment period, an additional 6-month treatment extension period, and a final 4-week follow-up period.
Ropeginterferon alfa-2b-njft will be given to people as an injection beneath the skin every 2 weeks. One group of people will start at a dose of 100 mcg, which will be gradually increased every 2 weeks up to a maximum dose of 500 mcg. Another group of people will start at a dose of 250 mcg, then be given 350 mcg at the next injection, and 500 mcg at the following injections.
Everyone taking part in the study will be given ropeginterferon alfa-2b-njft.
Click here to learn more about the ECLIPSE PV study.
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