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

NCT03003325 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 127

Last updated 2024-09-19

No results posted yet for this study

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.

Conditions

Interventions

DRUG

AOP2014

AOP2014 will be supplied to the patients as pre-filled auto-injection pens, containing 250 µg of active drug (0.5 ml solution for injection). One pen may be used twice within a time period of 4 weeks. Hence investigators will provide one prefilled pen at every monthly visit. AOP2014 will be self-injected subcutaneously by patients once every 14 days at the single doses of 100 µg (0.2 ml).

PROCEDURE

Phlebotomies

According to current common clinical practice the regimen must be selected accordingly to maintain the recommended level of HCT\< 45%. Once normalization of the hematocrit has been achieved, blood counts at regular intervals (every 4 weeks) will establish the frequency of future phlebotomies. Sufficient blood should be removed to maintain the hematocrit below 45%.

DRUG

ASA

100 mg/daily of ASA is recommended (when there are not contraindications) according with current guidelines for this risk class of patients

Sponsors & Collaborators

  • AOP Orphan Pharmaceuticals AG

    collaborator INDUSTRY

  • FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS

    lead OTHER

Principal Investigators

  • Tiziano Barbui, Professor · Fondazione per la Ricerca Ospedale Maggiore di Bergamo (FROM)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-02
Primary Completion
2022-03-31
Completion
2023-03-31

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03003325 on ClinicalTrials.gov