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

• Status: Active, not recruiting
• Trial end date: 2022-06-30
• Target enrollment: 0
• Participant gender: All

Summary

The Low-PV study is a multicenter, phase II, randomized trial aimed to assess whether the addition of Pegylated Proline-interferon-alpha-2b to the best therapeutic current strategy available based on phlebotomies and low dose acetylsalicylic acid (ASA) could improve the efficacy of treatment of patients with PV at low risk of thrombosis (younger than 60 years and without prior vascular events), in term of control of recommended level of hematocrit < 45%, over a period of 12 months.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fondazione per la Ricerca Ospedale Maggiore
• Collaborator: AOP Orphan Pharmaceuticals AG
• Treatments: Aspirin; Interferon-alpha; Interferons

Criteria

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 α

• 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 (β-hCG) test and confirm that childbearing women are not pregnant.