A Phase 3 Study of Rusfertide in Patients With Polycythemia Vera (VERIFY)
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|ClinicalTrials.gov Identifier: NCT05210790|
Recruitment Status : Recruiting
First Posted : January 27, 2022
Last Update Posted : January 27, 2023
|Condition or disease||Intervention/treatment||Phase|
|Polycythemia Vera||Drug: Placebo Drug: Rusfertide||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||250 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||
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.
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||A Phase 3 Study of the Hepcidin Mimetic Rusfertide (PTG-300) in Patients With Polycythemia Vera|
|Actual Study Start Date :||April 1, 2022|
|Estimated Primary Completion Date :||February 2024|
|Estimated Study Completion Date :||June 2025|
Rusfertide (32 Weeks) - Rusfertide (124 Weeks Open-label)
Placebo (32 Weeks) - Rusfertide (124 Weeks Open-label)
- Proportion of subjects achieving a response who receive rusfertide compared to placebo. [ Time Frame: Week 20 through Week 32 ]Response is defined as absence of phlebotomy eligibility.
- Comparison of mean number of phlebotomies between rusfertide and placebo. [ Time Frame: Week 0 to Week 32 ]
- Proportion of subjects with HCT values <45% for rusfertide and placebo. [ Time Frame: Week 0 to Week 32 ]
- Comparison mean change from baseline in total fatigue score based on PROMIS Short Form between rusfertide and placebo. [ Time Frame: Week 32 ]
- Comparison of mean change from baseline in total MFSAF total score. [ Time Frame: Week 32 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05210790
|Contact: Study Directoremail@example.com|