Combination Therapy with Interferon-Alpha2a and Ruxolitinib in Newly Diagnosed Patients with Polycythemia Vera. A Danish Safety and Efficacy Study.

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-518216-39-00

Acronym

30032016

Enrollment

Registered

2024-11-04

Start date

Unknown

Completion date

Unknown

Last updated

2024-11-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Polycythemia

Brief summary

Safety Profile: relevant adverse events (AE), serious AEs (SAE), withdrawal due to AEs/SAE

Detailed description

1. Safety Profile: adverse events (AE), serious AEs (SAE), withdrawal, AEs/SAEs 2. Efficacy Profile: a) Proportion of patients achieving complete hematological remission (HCT < 45, PLA ≤400 and WBC < 10) after 3, 6, 8, 9, 12, 18 and 24 months. b) Remission rates at 12 and 24 months. c) JAK2V617F allele burden measured at baseline and after 3,6,12 and 24 months. d) Proportion of patients suffering thrombosis and/or hemorrhage at 12 at 24 months. with more e)-j)

Interventions

DRUGPEGINTERFERON ALFA-2A

DRUGJakavi 5 mg tablets

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Safety Profile: relevant adverse events (AE), serious AEs (SAE), withdrawal due to AEs/SAE	—

Secondary

Measure	Time frame
1. Safety Profile: adverse events (AE), serious AEs (SAE), withdrawal, AEs/SAEs 2. Efficacy Profile: a) Proportion of patients achieving complete hematological remission (HCT < 45, PLA ≤400 and WBC < 10) after 3, 6, 8, 9, 12, 18 and 24 months. b) Remission rates at 12 and 24 months. c) JAK2V617F allele burden measured at baseline and after 3,6,12 and 24 months. d) Proportion of patients suffering thrombosis and/or hemorrhage at 12 at 24 months. with more e)-j)	—

Measure

Time frame

—

Countries

Denmark

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026