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MITHRIDATE: Ruxolitinib Versus Hydroxycarbamide or Interferon as First Line Therapy in High Risk Polycythemia Vera

NCT04116502 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 586

Last updated 2026-04-28

No results posted yet for this study

Summary

The trial will be a phase III, randomised-controlled, multi-centre, international, open-label trial consisting of ruxolitinib versus best available therapy, where best available therapy is a choice of interferon alpha, any formulation permitted (IFN) or hydroxycarbamide (HC), and which will be elected by the Investigator prior to randomisation.

Conditions

Interventions

DRUG

Ruxolitinib

10mg of ruxolitinib twice daily (bd)

DRUG

Hydroxycarbamide

Via standard hospital mechanisms

DRUG

Interferon-Alpha

Any formulation, via standard hospital mechanisms

Sponsors & Collaborators

  • Novartis

    collaborator INDUSTRY

  • MPN Voice

    collaborator UNKNOWN

  • French National Cancer Institute (Institut National Du Cancer - France)

    collaborator UNKNOWN

  • University of Birmingham

    lead OTHER

Principal Investigators

  • Claire Harrison · Acting on behalf of the Sponsor (UK), Guy's Hospital, London, UK, SE1 9RT

  • Jean-Jacques Kiladjian · (France) Clinical Investigations Center, Saint-Louis Hospital, Paris, France

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-25
Primary Completion
2028-10-31
Completion
2030-04-01

Countries

  • United Kingdom

Study Locations

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Entities

Drugs
Diseases
Companies

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 NCT04116502 on ClinicalTrials.gov