This is a multi-centre phase 2 open-label prospective study designed to assess the efficacy and safety of ropeg patients with pre-fibrotic primary myelofibrosis or DIPSS low/intermediate-1 risk myelofibrosis after 24 months of treatment.
Adults ≥ 18 years (or based on the legal age of the territory) Diagnosed of primary myelofibrosis, post-PV and post-ET myelofibrosis according to the WHO 2016 classification Bone marrow reticulin fibrosis grade of 0-1 or low/intermediate-1 risk according to DIPSS Compensated liver function defined as: bilirubin ≤ 1.5 x upper limit normal (ULN); alanine aminotransferase (ALT) ≤ 2 x ULNor aspartate aminotransferase (AST) ≤ 2 x ULN; prothrombin time versus control <3 seconds at screening Glomerular filtration rate ≥ 50 mL/min (by MDRD equation or Cockcroft-Gault formula) Men and women of childbearing potential must agree to perform contraception until 28 days after the last dose of ropeg.
Prior or current use of IFNα preparations for PMF or secondary MF. Prior use of IFNα for antecedent PV or ET is allowed provided that the time from the last dose of IFNα to recruitment is > 4 weeks.
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Taiwan