NCT04655092RecruitingPhase 3
Extension Study of P1101 After Completion of Phase 2 Study in PV Patients or Phase 3 Study in ET Patients
Extension Study of P1101 in Japanese Patients Who Have Completed Phase 2 Single Arm Study in Polycythemia Vera (PV) Patients (Study A19-201) or Phase 3 Study in Essential Thrombocythemia (ET) Patients (Study P1101 ET)
Source: ClinicalTrials.gov · Last updated 8 Nov 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 67 (estimated)
- First submitted
- 18 Nov 2020
- Start date
- Jan 2021
- Primary completion date
- Jun 2026
- Lead sponsor
- PharmaEssentia Japan K.K.
- Diseases
- Myeloproliferative neoplasms
- NCT number
- NCT04655092
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 67
- From Jan 2021 to the primary completion date, Jun 2026
- 6 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients who are considered by the investigator or sub investigator to be ineligible for continued treatment with P1101
Who the study is looking for
- 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
Age in the registry: 20 years to - · Sex: All · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Juntendo University Hospital Coordinator of this site? Confirm its status | Bunkyo-ku | Japan | Recruiting |
| University of Yamanashi Hospital Coordinator of this site? Confirm its status | Chuo-shi | Japan | Recruiting |
| Tokyo Medical University Hospital Coordinator of this site? Confirm its status | Shinjuku-ku | Japan | Recruiting |
| Osaka University Hospital Coordinator of this site? Confirm its status | Suita-shi | Japan | Recruiting |
| Ehime University Hospital Coordinator of this site? Confirm its status | Toon-shi | Japan | Recruiting |
| Mie University Hospital Coordinator of this site? Confirm its status | Tsu | Japan | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.