A Study to Assess Efficacy, Safety, and Tolerability of P1101 in Adult Patients With PV (NCT05481151) | Clinical Trial Compass
Active — Not RecruitingPhase 3
A Study to Assess Efficacy, Safety, and Tolerability of P1101 in Adult Patients With PV
United States, Canada111 participantsStarted 2022-10-26
Plain-language summary
A Study to Assess Efficacy, Safety, and Tolerability of P1101 in Adult Patients with PV
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Male or female subjects aged ≥18 years at the time of signing the informed consent form
. Subjects diagnosed with PV according to the 2008 or 2016 World Health Organization (WHO) criteria
. Subjects with good liver function at screening, which is defined as total bilirubin ≤1.5 × upper limit of normal (ULN), international normalized ratio (INR) ≤1.5 × ULN, albumin \>3.5 g/dL, alanine aminotransferase (ALT) ≤2.0 × ULN, and aspartate aminotransferase (AST) ≤2.0 × ULN
. Hemoglobin (HGB) ≥10 g/dL for females, and HGB ≥11 g/dL for males at screening
. Neutrophil count ≥1.5 × 10\^9/L at screening
. Creatinine clearance rate ≥40 mL/min at screening (according to the Cockcroft-Gault formula)
. Males and females of childbearing potential, as well as all women \<2 years after the onset of menopause, must agree to use an acceptable form of birth control until 60 days following the last dose of the study drug, and females must agree to not breastfeed during the study
. Written informed consent obtained from the subject and ability for the subject to comply with the requirements of the study
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Compare efficacy, safety, and tolerability of P1101 utilizing 250-350-500 mcg compared to the current labeled dosing through assessing the proportion of subjects that are in a complete hematologic response at Week 24.
. Any contraindications to interferon alfa or hypersensitivity to interferon alfa
. Subjects who stopped prior to interferon alfa therapy due to low efficacy or poor tolerability
. Subjects with severe or serious diseases that the Investigator determines may affect the subject's participation in this study
. History of major organ transplantation
. Pregnant or breastfeeding women
. Subjects with any other diseases that the Investigator determines will affect the study results or may weaken the compliance to protocol, including but not limited to:
. Prior or current autoimmune thyroid disease (clinical symptoms of hyper- or hypo-thyroidism), except subjects with controlled thyroid replacement therapy, could be enrolled
. Other documented autoimmune diseases (such as hepatitis, immune thrombocytopenia \[ITP\], scleroderma, psoriasis, or any autoimmune arthritis)