Clinical trial · Interventional
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
NCT05210790CI-TRIAL-00093248VERIFYactive not recruitingPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Polycythemia Vera | Polycythemia Vera | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Placebo | Drug | — | UNRESOLVED |
| Rusfertide | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Rusfertide
- description
- Rusfertide (32 Weeks) - Rusfertide (124 Weeks Open-label)
- interventionNames
- Drug: Rusfertide
- type
- EXPERIMENTAL
- label
- Placebo
- description
- Placebo (32 Weeks) - Rusfertide (124 Weeks Open-label)
- interventionNames
- Drug: Placebo
- Drug: Rusfertide
Primary outcomes (1)
- measure
- Proportion of subjects achieving a response who receive rusfertide compared to placebo.
- timeFrame
- Week 20 through Week 32
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Main Inclusion Criteria: All subjects must meet ALL of the following inclusion criteria to be enrolled. There are additional inclusion criteria. * Male and female subjects aged 18 (or the country specific minimum age of consent \>18) years or older. * Meet revised 2016 World Health Organization (WHO) criteria for the diagnosis of polycythemia vera. * At least 3 phlebotomies due to inadequate hematocrit control in 6 months before randomization or at least 5 phlebotomies due to inadequate hematocrit control in 1 year before randomization. * CBC values immediately prior to randomization: 1. Hematocrit \<45%, 2. WBC 4000/μL to 20,000/μL (inclusive), and 3. Platelets 100,000/μL to 1,000,000/μL (inclusive) * Subjects receiving cytoreductive therapy at randomization must be on a stable PV therapy regimen. * Subjects treated with phlebotomy alone at randomization must have stopped cytoreductive therapy 2 to 6 months before screening. Main Exclusion Criteria: Subjects must meet NONE of the following exclusion criteria to be enrolled. There are additional exclusion criteria. * Clinically meaningful laboratory abnormalities at Screening. * Subjects who require phlebotomy at hematocrit levels lower than 45%. * Clinically significant thrombosis (e.g., deep vein thrombosis or splenic vein thrombosis) within 2 months prior to randomization. * Active or chronic bleeding within 2 months prior to randomization. * History of invasive malignancies within the last 5 years, except localized cured prostate cancer and cervical cancer. * Subjects with in situ or stage 1 squamous cell carcinoma of the skin, in situ or stage 1 basal cell carcinoma of the skin, or in situ melanoma of the skin identified during screen unless the cancer is adequately treated before randomization. * Received Busulfan, Pipobroman or 32Phosphorus within 7 months prior to screening.
References
Publications (0)
Data not yet available
No reference posted for this study.