Long-term treatment with P1101 for patients with Polycythemia Vera or Essential Thrombocythemia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 3 open-label, multicenter study aims to evaluate the long-term safety and efficacy of P1101 in patients with Polycythemia Vera (PV) or Essential Thrombocythemia (ET) who have previously participated in related studies. Participants who completed a 52-week treatment with P1101 or have been treated with anagrelide will receive P1101 at a specified dose, which may be adjusted based on their condition. The study will assess various safety and efficacy parameters, including vital signs, laboratory tests, and spleen size measurements, to determine the treatment's overall impact.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 for participation in this study
* Patients who have given written informed consent to participate in this study

Exclusion Criteria:

* Patients who are considered by the investigator or sub investigator to be ineligible for continued treatment with P1101

Where it's running

• Ehime University Hospital
  Toon-shi, Ehime, Japan Recruiting
• Mie University Hospital
  Tsu, Mie-ken, Japan Recruiting
• Osaka University Hospital
  Suita-shi, Osaka, Japan Recruiting
• Juntendo University Hospital
  Bunkyo-ku, Tokyo, Japan Recruiting
• Tokyo Medical University Hospital
  Shinjuku-ku, Tokyo, Japan Recruiting
• University of Yamanashi Hospital
  Chuo-shi, Yamanashi, Japan Recruiting

Study contacts

• Principal investigator: Keita Kirito, MD — University of Yamanashi Hospital
• Study coordinator: Hiroaki Kawase
• Email: hiroaki_kawase@pharmaessentia.com
• Phone: +81-3-6910-5103

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Gecacitinib plus pegylated interferon for polycythemia vera

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• Using low-dose Methotrexate for treating blood cancers

  This study is testing if adding low-dose Methotrexate to the treatment of blood cancers like Polycythemia Vera and Myelofibrosis can help reduce symptoms and improve spleen size for patients.

  Recruiting Phase 2 Icahn School of Medicine at Mount Sinai · New York, New York · NCT06541249

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.