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New treatment option for Polycythemia Vera (PV)
Official title Extension Study of P1101 After Completion of Phase 2 Study in PV Patients or Phase 3 Study in ET Patients
ClinicalTrials.gov ID: NCT04655092
What this study is testing
What is P1101 (Ropeginterferon alfa-2b)?
P1101 (Ropeginterferon alfa-2b) is an investigational medicine, being studied as a potential treatment for polycythemia vera (pv).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a Phase 3 open-label, multicenter, single arm study designed to evaluate the efficacy and safety and tolerability of P1101 patient with PV or ET in long-term.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 20 and older
You may be able to join if
- Patients who have completed the 52-week treatment duration in Study A19-201 and are considered by the investigator or sub investigator to be eligible...
- Patients who have given written informed consent to participate in this study
You likely can't join if
- Patients who are considered by the investigator or sub investigator to be ineligible for continued treatment with P1101
The study team makes the final eligibility decision.
Where it's taking place
- Toon-shi, Ehime, Japan
- Tsu, Mie-ken, Japan
- Suita-shi, Osaka, Japan
- Bunkyo-ku, Tokyo, Japan
- Shinjuku-ku, Tokyo, Japan
- Chuo-shi, Yamanashi, Japan
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, 20 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Toon-shi, Ehime, Japan; Tsu, Mie-ken, Japan; Suita-shi, Osaka, Japan; Bunkyo-ku, Tokyo, Japan; Shinjuku-ku, Tokyo, Japan; Chuo-shi, Yamanashi, Japan. 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 ClinicalTrials.gov; the study team decides eligibility.