Clinical trial · Interventional
Study to Evaluate the Long-term Safety of Rusfertide (PTG-300) in Subjects With Polycythemia Vera
An Extension Study to Evaluate the Long-term Safety of Rusfertide (PTG-300) in Subjects With Polycythemia Vera (THRIVE)
NCT06033586CI-TRIAL-00093173THRIVEactive 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 goal of this clinical trial is to assess long-term safety and efficacy of rusfertide in subjects with polycythemia vera. Subjects who complete dosing with rusfertide until the end-of-treatment visit of a Phase 2 rusfertide study and meet the inclusion/exclusion criteria for this study, are eligible to participate in this open-label study and continue treatment with rusfertide.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Open-label rusfertide | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Open-label rusfertide
- description
- Open-label rusfertide
- interventionNames
- Drug: Open-label rusfertide
Primary outcomes (2)
- measure
- Hematocrit
- timeFrame
- 0-2 years
- description
- Median hematocrit
- measure
- Phlebotomies
- timeFrame
- 0-2 years
- description
- Number of phlebotomies
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Subject who has completed at least 12 months of dosing with rusfertide and successfully completed the end of treatment visit of a previous Phase 2 study of rusfertide. * Subject understands the study procedures, is willing and able to adhere to study requirements and agrees to participate in the study by giving written informed consent. Key Exclusion Criteria: * Subject who, in the opinion of the investigator, should not participate in the study. * Subject who discontinue early from a previous rusfertide study for reasons other than enrolling in this study. * Pregnant or lactating females. * Women of childbearing potential (WOCBP) who do not agree to use medically acceptable contraception (\<1% annual failure rate) during the study and for 30 days after the last dose of study drug. * Men with partners of childbearing potential who do not agree to use medically acceptable contraception (\<1% annual failure rate) during the study and for 90 days after the last dose of study drug. * Men who do not agree to use a condom during the study and for 90 days after the last dose of study drug regardless of the partner's childbearing potential. * A female subject intends to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for a period of 30 days after receiving the last dose of study drug. * A male subject intends to donate sperm for the purpose of reproduction during the study and for a minimum of 90 days after receiving the last dose of study drug. * Plan to use investigational treatment other than rusfertide during the course of the study or within 28 days after last rusfertide dose. * Subject with hypersensitivity to rusfertide or to any of the excipients. * In the investigator's opinion the subject has progressive disease that cannot be managed by adjusting concurrent cytoreductive therapy.
References
Publications (0)
Data not yet available
No reference posted for this study.