Evaluation of the effects of pegylated-proline-Interferon-alpha-2b (AOP2014) added to the best available therapy based on phlebotomies in low-risk patients with Polycythemia Vera (PV), who are younger than 60 and who have never experienced thrombosis.

Phase 1

• Conditions: Polycythemia Vera; MedDRA version: 20.0Level: LLTClassification code 10036061Term: Polycythemia veraSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2015-004717-25-IT
• Lead Sponsor: FONDAZIONE PER LA RICERCA OSPEDALE MAGGIORE DI BERGAMO - FROM

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-05-19
• Last Update Posted: 2 October 2017

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

1.Age 18-60 years
2.Diagnosis of Polycythemia Vera according to WHO 2008 criteria
3.Diagnosis of Polycythemia Vera performed within 3 years prior inclusion in the study and never treated with cytoreductive drugs
4.HCT<45%
5.Ability and willingness to comply with all study requirements
6.Signed written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range: 1
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 150
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Any previous well documented cardiovascular PV-related events (see Appendix 1 for description)
2.Previous cytoreductive drugs
3.Known hypersensitivity or contraindications to the IMP (Pegylated Proline-Interferon alpha-2b)
4.Previous exposure to a non-pegylated or pegylated interferon a
5.Clinically relevant pulmonary infiltrates, pneumonia, and pneumonitis
6.Systemic infections, e.g. hepatitis B, hepatitis C, or HIV at screening
7.Significant liver (AST or ALT > 2.5 times ULN) or renal disease (creatinine > 2 mg/ml)
8.Presence of any life-threatening condition or of any disease (e.g. cancer) that is likely to significantly shorten life expectancy
9.History of active substance or alcohol abuse within the last year
10.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
11.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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified