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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05210790
Registration number
NCT05210790
Ethics application status
Date submitted
14/01/2022
Date registered
27/01/2022
Date last updated
17/07/2024
Titles & IDs
Public title
A Phase 3 Study of Rusfertide in Patients With Polycythemia Vera
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Scientific title
A Phase 3 Study of the Hepcidin Mimetic Rusfertide (PTG-300) in Patients With Polycythemia Vera
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Secondary ID [1]
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PTG-300-11
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Universal Trial Number (UTN)
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Trial acronym
VERIFY
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Polycythemia Vera
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Condition category
Condition code
Blood
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Haematological diseases
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Blood
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Other blood disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Placebo
Treatment: Drugs - Rusfertide
Experimental: Rusfertide - Rusfertide (32 Weeks) - Rusfertide (124 Weeks Open-label)
Experimental: Placebo - Placebo (32 Weeks) - Rusfertide (124 Weeks Open-label)
Treatment: Drugs: Placebo
Placebo
Treatment: Drugs: Rusfertide
Experimental drug
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Proportion of subjects achieving a response who receive rusfertide compared to placebo.
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Assessment method [1]
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Response is defined as absence of phlebotomy eligibility.
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Timepoint [1]
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Week 20 through Week 32
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Secondary outcome [1]
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Comparison of mean number of phlebotomies between rusfertide and placebo.
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Assessment method [1]
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Timepoint [1]
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Week 0 to Week 32
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Secondary outcome [2]
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Proportion of subjects with HCT values <45% for rusfertide and placebo.
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Assessment method [2]
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Timepoint [2]
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Week 0 to Week 32
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Secondary outcome [3]
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Comparison mean change from baseline in total fatigue score based on PROMIS Short Form between rusfertide and placebo.
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Assessment method [3]
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Timepoint [3]
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Week 32
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Secondary outcome [4]
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Comparison of mean change from baseline in total MFSAF total score.
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Assessment method [4]
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Timepoint [4]
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Week 32
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Eligibility
Key inclusion criteria
Main 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.
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Minimum age
18
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/04/2022
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/06/2025
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Actual
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Sample size
Target
250
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
PerthSA,VIC
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Recruitment hospital [1]
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One Clinical Research - Nedlands
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Royal Adelaide Hospital - Adelaide
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The Alfred Hospital - Melbourne
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- Nedlands
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5000 - Adelaide
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Recruitment postcode(s) [3]
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3004 - Melbourne
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Name
Protagonist Therapeutics, Inc.
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Ethics approval
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Summary
Brief summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT05210790
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Trial related presentations / publications
Pemmaraju N, Kuykendall A, Kremyanskaya M, Ginzburg Y, Ritchie E, Gotlib J, Gerds A, Palmer J, Valone F, O'Connor P, Modi N, Gupta S, Hoffman R, Verstovsek S. MPN-469 Rusfertide (PTG-300) Treatment Interruption Reverses Hematological Gains and Upon Reinitiation, Restoration of Clinical Benefit Observed in Patients With Polycythemia Vera. Clin Lymphoma Myeloma Leuk. 2022 Oct;22 Suppl 2:S338-S339. doi: 10.1016/S2152-2650(22)01462-8.
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Public notes
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Contacts
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1-888-899-1543
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[email protected]
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT05210790
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