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A Phase 3 Study of Rusfertide (PTG-300) in Patients with Polycythemia Vera
EU CTIS ID: 2023-509750-58-00
What this study is testing
To evaluate the safety and efficacy of rusfertide in subjects with polycythemia vera in maintaining hematocrit control.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1 - Male and female subjects aged 18 (or the minimum country specific age of consent if >18) years or older.
- 2 - Meet revised 2016 World Health Organization (WHO) criteria for the diagnosis of polycythemia vera
- 3 - Phlebotomy requiring defined as ALL of the following: a. At least 3 phlebotomies due to inadequate hematocrit control in 28 weeks before randomization or at least 5 phlebotomies due to inadequate hematocrit control in 1 year before randomization, and b. Last phlebotomy due to inadequate hematocrit control within 3 months before randomization, and c. No phlebotomy within 6 days prior to randomization (do not include day of phlebotomy and day of randomization in the 6-day count). Note: Phlebotomies performed within an 8-day period will be counted as a single phlebotomy
- 4 - CBC values immediately prior to randomization: a. Hematocrit <45%, b. WBC 4000/µL to 20,000/µL (inclusive) and c. Platelets 100,000/µL to 1,000,000/µL (inclusive).
- 5 - Subjects receiving cytoreductive therapy at randomization must be on a stable PV therapy regimen
- 6 - Subjects treated with phlebotomy alone at randomization must have stopped cytoreductive therapy 2 to 6 months before screening.
You likely can't join if
- 1 - Clinically meaningful laboratory abnormalities at Screening
- 2 - Subjects who require phlebotomy at hematocrit levels lower than 45%
- 3 - Clinically significant thrombosis (e.g., deep vein thrombosis or splenic vein thrombosis) within 2 months prior to randomization.
- 4 - Active or chronic bleeding within 2 months prior to randomization.
- 5 - History of invasive malignancies within the last 5 years, except a) localized cured cancer (e.g. prostate cancer and cervical cancer). b) localized cured in situ or stage 1 squamous cell carcinoma of the skin, basal cell carcinoma of the skin, or in situ melanoma of the skin.
- 6 - 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 screening unless the cancer is adequately treated before randomization.
See the full eligibility criteria
- 1 - Male and female subjects aged 18 (or the minimum country specific age of consent if >18) years or older.
- 2 - Meet revised 2016 World Health Organization (WHO) criteria for the diagnosis of polycythemia vera
- 3 - Phlebotomy requiring defined as ALL of the following: a. At least 3 phlebotomies due to inadequate hematocrit control in 28 weeks before randomization or at least 5 phlebotomies due to inadequate hematocrit control in 1 year before randomization, and b. Last phlebotomy due to inadequate hematocrit control within 3 months before randomization, and c. No phlebotomy within 6 days prior to randomization (do not include day of phlebotomy and day of randomization in the 6-day count). Note: Phlebotomies performed within an 8-day period will be counted as a single phlebotomy
- 4 - CBC values immediately prior to randomization: a. Hematocrit <45%, b. WBC 4000/µL to 20,000/µL (inclusive) and c. Platelets 100,000/µL to 1,000,000/µL (inclusive).
- 5 - Subjects receiving cytoreductive therapy at randomization must be on a stable PV therapy regimen
- 6 - Subjects treated with phlebotomy alone at randomization must have stopped cytoreductive therapy 2 to 6 months before screening.
- 1 - Clinically meaningful laboratory abnormalities at Screening
- 2 - Subjects who require phlebotomy at hematocrit levels lower than 45%
- 3 - Clinically significant thrombosis (e.g., deep vein thrombosis or splenic vein thrombosis) within 2 months prior to randomization.
- 4 - Active or chronic bleeding within 2 months prior to randomization.
- 5 - History of invasive malignancies within the last 5 years, except a) localized cured cancer (e.g. prostate cancer and cervical cancer). b) localized cured in situ or stage 1 squamous cell carcinoma of the skin, basal cell carcinoma of the skin, or in situ melanoma of the skin.
- 6 - 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 screening unless the cancer is adequately treated before randomization.
- 7 - Received busulfan, pipobroman or 32Phosphorus within 7 months prior to screening.
The study team makes the final eligibility decision.
Where it's taking place
- Canada
- Israel
- Mexico
- United Kingdom
- Hong Kong
- Chile
- Australia
- Turkey
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Canada; Israel; Mexico; United Kingdom; Hong Kong; Chile and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.