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VERIFY Study & Therapy

What is the VERIFY study?

The purpose of the VERIFY clinical trial is to evaluate how safe and effective rusfertide is in maintaining hematocrit control and improving PV symptoms.

What is rusfertide?

Rusfertide, also known as PTG-300, is an investigational drug designed to slow the release of iron into the blood. The body needs iron to make red blood cells. With less iron in the blood, the body is not able to make as many red blood cells. As a result, rusfertide may help keep hematocrit levels under control.  Investigational means the study medication is not approved by regulatory authorities like the US Food and Drug Administration (FDA) or the European Medicines Agency (EMA), and it can only be used in clinical research studies like the VERIFY study.

The VERIFY study

This study is evaluating the ability for rusfertide to control the number of red blood cells (hematocrit level) to reduce, delay or eliminate phlebotomy, and improve  patients’ quality of life.

Participation in the VERIFY study is divided into three parts and can last up to 166 weeks (slightly over 3 years).

Study participants can expect to:

The study layout below explains the 3 parts of the study in more detail:

Part 1a

Part 1b

Part 2

Description
Participants will be randomized and will have a 50% chance to receive rusfertide drug or a 50% chance to receive placebo. Participants continue to receive their current PV therapy.
All participants receive rusfertide. Participants continue to receive their current PV therapy.
All participants receive rusfertide. Participants continue current PV therapy. Your study doctor may adjust your PV therapies or begin new PV therapies as necessary.
Duration
32 weeks
(Weeks 0-32)
20 weeks
(Weeks 32-52)
104 weeks
(Weeks 52-156)
Visit Frequency
Once every 2 weeks through week 8; once every 4 weeks through week 32
Once every 4 weeks
Once every 12 weeks

Participation in a clinical study is voluntary. You can ask any questions you have and may leave the study at any time, for any reason.

Can I receive other PV therapies?

For the first year you will continue to receive the therapy you received before participating in the study. After the first year, your doctor may adjust your existing PV therapies or begin new PV therapies as necessary.