Neoplasms

Blood and Lymph Conditions

All Conditions

Rare Diseases

Polycythemia Vera

Polycythemia

Hematologic Diseases

Bone Marrow Neoplasms

Hematologic Neoplasms

Bone Marrow Diseases

Myeloproliferative Disorders

Chronic Myeloproliferative Disorders

Anti-Infective Agents

All Drugs and Chemicals

Hepcidins

Rusfertide (32 Weeks) - Rusfertide (124 Weeks Open-label)

Placebo (32 Weeks) - Rusfertide (124 Weeks Open-label)

Placebo

Rusfertide

Study Director

The study is designed to evaluate the safety and efficacy of rusfertide in subjects with polycythemia vera (PV) in maintaining hematocrit control and in improving symptoms of PV.

Phase 3 study in approximately 250 subjects previously diagnosed with polycythemia vera (PV) who require phlebotomy on a routine basis. There is a 32-week period during which rusfertide or placebo will be added-on to each subject's ongoing therapy for polycythemia vera which may include phlebotomy only or phlebotomy plus stable doses of either of hydroxyurea, interferon and/or ruxolitinib. All subjects who successfully complete the double blind 32-week portion of the study will receive rusfertide for 124 weeks. Approximately 6 and 12 months after their last dose of rusfertide, subjects will have a post-study contact (e.g. by phone) for safety.

Randomized, Double-blind (Part 1a):

Subjects will be randomized in a blinded fashion to 32 weeks of rusfertide or placebo added-on to each subject's ongoing treatment for polycythemia vera.

Open-label (Part 1b + Part 2):

Open-label treatment phase during which all subjects who complete Part 1a successfully will receive rusfertide for 124 weeks.

A Phase 3 Study of Rusfertide in Patients With Polycythemia Vera

A Phase 3 Study of the Hepcidin Mimetic Rusfertide (PTG-300) in Patients With Polycythemia Vera

Response is defined as absence of phlebotomy eligibility.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Phase 3 Study of Rusfertide in Patients With Polycythemia Vera	NCT05210790	Polycythemia Ve...	Placebo Rusfertide	18 Years -	Protagonist Therapeutics, Inc.
A Phase 3 Study of Rusfertide in Patients With Polycythemia Vera	NCT05210790	Polycythemia Ve...	Placebo Rusfertide	18 Years -	Protagonist Therapeutics, Inc.

Spots Global Cancer Trial Database for rusfertide

Every month we try and update this database with for rusfertide cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for rusfertide

Every month we try and update this database with for rusfertide cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for rusfertide cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.