Last updated on November 2019

The Benefit/Risk Profile of AOP2014 in Low-risk Patients With PV

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Polycythemia Vera
  • Age: Between 18 - 60 Years
  • Gender: Male or Female

Inclusion Criteria:

  • Age 18-60 years
  • Diagnosis of Polycythemia Vera according to World Health Organization 2016 criteria
  • Diagnosis of Polycythemia Vera including a recent bone marrow (BM) biopsy (performed within 3 years prior randomization in the study) and never treated with cytoreductive drugs
  • HCT<45%
  • Ability and willingness to comply with all study requirements
  • Signed written informed consent.

Exclusion Criteria:

  • Any previous well documented cardiovascular PV-related events (see Appendix 1 for description)
  • Previous cytoreductive drugs
  • Known hypersensitivity or contraindications to the Investigational Medicinal Product (Pegylated Proline-Interferon alpha-2b) including:

evidence of severe retinopathy (e.g. cytomegalovirus retinitis, macular degeneration) or clinically relevant ophthalmological disorder (due to diabetes mellitus or hypertension); thyroid dysfunction not adequately controlled; patients tested positively with Thyroglobulin antibody and / or TPOAb at screening; documented autoimmune disease at screening or in the medical history; history or presence of depression requiring treatment with antidepressant; any risk of suicide at screening or previous suicide attempts;

  • Previous exposure to a non-pegylated or pegylated interferon
  • Clinically relevant pulmonary infiltrates, pneumonia, and pneumonitis
  • Systemic infections, e.g. hepatitis B, hepatitis C, or HIV at screening
  • Significant liver (AST or alanine aminotransferase > 2.5 times ULN) or renal disease (creatinine > 2 mg/ml)
  • Presence of any life-threatening condition or of any disease (e.g. cancer) that is likely to significantly shorten life expectancy
  • History of active substance or alcohol abuse within the last year
  • Any condition that in the opinion of the investigator would jeopardize the evaluation of efficacy or safety or be associated with poor adherence to the protocol
  • Pregnant or lactating women and women*/men of childbearing potential who are not using or are not willing to use any effective means of contraception (i.e. sexual abstinence, hormonal contraceptive, intra-uterine device, barrier method such as diaphragms or condoms, surgical methods).
  • Pregnancy test will be performed in order to ascertain negativity of human chorionic gonadotropin (-hCG) test and confirm that childbearing women are not pregnant.

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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