A Phase III b study to evaluate P1101 in Japanese PV patients
- Conditions
- Polycythemia VeraMyeloproliferative nemoplasms
- Registration Number
- JPRN-jRCT2031230267
- Lead Sponsor
- Kawase Hiroaki
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 20
1. Male or female patients >=18 years old at the time of informed consent to participate in the study
2. Patients diagnosed with PV according to the WHO 2008 or 2016 criteria
3. Patients with PV who have the inadequate response to an existing therapy or whom the existing therapy is inappropriate to apply
4. Patients who have given written informed consent to participate in this study
1. Any contraindications to interferon alfa or hypersensitivity to interferon alfa
2. Subjects who stopped prior to interferon alfa therapy due to low efficacy or poor tolerability
3. Subjects with severe or serious diseases that the Investigator determines may affect the subject's participation in this study
4. History of major organ transplantation
5. Pregnant or breastfeeding women
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method