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Rusfertide

Clinical trials are investigating Rusfertide in people with polycythemia vera. The main goal is to see whether it can help maintain hematocrit control and how well it works compared with placebo. This article focuses on the study design, phase, participants, and outcomes being measured.

Table of Contents

Trial overview

The provided clinical trial is a Phase 3 study of Rusfertide in people with polycythemia vera, a blood disorder listed in the source data.[1] The study is designed to evaluate the safety and efficacy of Rusfertide in maintaining hematocrit control.[1]

Study design and treatment groups

This is an interventional study, which means researchers assign a treatment and then measure the results.[1] The trial includes Rusfertide dose groups listed as 10 mg, 20 mg, 30 mg, 45 mg, and 60 mg, all given by subcutaneous use, and a placebo group designed to match PTG-300 for injection.[1]

The source also notes that the placebo is a lyophilized powder formulation with the drug substance omitted.[1] Lyophilized powder means a freeze-dried form that is prepared for injection.[1]

Who can participate

The trial is for subjects with polycythemia vera.[1] The provided data do not list other entry rules, such as age limits, prior treatments, or lab thresholds for joining the study.[1]

What is being measured

The main outcome is the proportion of subjects who achieve a response from Week 20 through Week 32 inclusive.[1] In this study, a response means absence of phlebotomy eligibility.[1]

Phlebotomy eligibility is defined in the source as either a confirmed hematocrit of 45% or higher that is at least 3% above the baseline hematocrit, or a hematocrit of 48% or higher.[1] Baseline hematocrit means the value right before randomization at Week 0.[1]

In simple terms, the study is checking whether Rusfertide helps more people stay below the level where blood removal would be needed.[1]

Study status and size

The trial status is listed as Authorised.[1] The planned enrollment is 250 participants, which is the number of people the study aims to include.[1]

Because this is a Phase 3 study, it is a later-stage trial that usually helps show how well a treatment works in a larger group while also watching safety.[1] In this case, the focus is on whether Rusfertide can maintain hematocrit control better than placebo in polycythemia vera.[1]

Trial ID Phase Condition studied Status Enrollment
NCT05210790 Phase 3 Polycythemia Vera Authorised 250

FAQ

  • What condition is Rusfertide being studied for? In the trial data provided, Rusfertide is being studied for polycythemia vera. This is the only condition listed in the source.
  • What phase is the Rusfertide trial? The trial is a Phase 3 study. Phase 3 trials are usually larger studies that test how well a treatment works and continue to monitor safety.
  • Who may take part in the study? The trial is for patients with polycythemia vera. The source does not list more detailed entry rules, such as age limits or lab requirements.
  • What is the main goal of the study? The study aims to evaluate the safety and efficacy of Rusfertide in maintaining hematocrit control. Efficacy means how well the treatment works.
  • What outcome is the study measuring? The main outcome is the proportion of subjects who achieve a response from Week 20 through Week 32. A response means they are not eligible for phlebotomy, which is a blood removal procedure used when hematocrit is too high.

Ongoing Clinical Trials on Rusfertide

  • Study on the Effects of Rusfertide (PTG-300) for Patients with Polycythemia Vera

    Not recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Austria Belgium Czechia France Germany Hungary +5

Glossary

  • Polycythemia vera: A blood disorder in which the body makes too many red blood cells. This can raise hematocrit and may increase the need for blood removal treatment.
  • Phase 3: A later stage of clinical research with a larger group of participants. It helps show whether a treatment works and continues to assess safety.
  • Placebo: A look-alike treatment that does not contain the study drug. It is used to compare results fairly.
  • Hematocrit: The percentage of blood made up of red blood cells. A higher value can mean the blood is too thick.
  • Hematocrit control: Keeping the hematocrit within a desired range so it does not rise too high.
  • Phlebotomy: A procedure that removes blood from the body. In this study, phlebotomy eligibility is used as a sign that hematocrit is too high.
  • Phlebotomy eligibility: The study’s rule for when a person would need blood removal. Here, it is defined by specific hematocrit levels.
  • Randomization: A process that assigns participants by chance to different study groups, such as Rusfertide or placebo.
  • Interventional study: A clinical trial where researchers give a treatment or compare treatments to see what happens.
  • Efficacy: How well a treatment works for the condition being studied.

References