Your session is about to expire
← Back to Search
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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
Timeline
Screening 28 days
Treatment 48 weeks
Follow Up 28 days
Awards & highlights
Study Summary
This triallooks at how a drug affects people with a blood disorder called polycythemia vera, to assess safety and effectiveness.
Who is the study for?
Adults with Polycythemia Vera (PV) can join this trial if they have certain levels of hemoglobin, good liver function, adequate neutrophil counts, and sufficient kidney clearance. Women must not breastfeed and those who can bear children should use birth control during the study.Check my eligibility
What is being tested?
The trial is testing P1101 (Ropeginterferon alfa-2b-njft), a medication for PV. It aims to see how well it works, its safety profile, and how tolerable it is for patients when taken as prescribed in the study protocol.See study design
What are the potential side effects?
While specific side effects are not listed here, common ones associated with interferons like P1101 may include flu-like symptoms, tiredness, mood changes, nausea, and injection site reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My liver is functioning well according to recent tests.
Select...
My hemoglobin level is at least 10 g/dL if I am female, or 11 g/dL if I am male.
Select...
My kidneys are functioning well enough (creatinine clearance rate ≥40 mL/min).
Select...
I agree to use birth control during and 60 days after the study, and I won't breastfeed if participating.
Timeline
Screening ~ 28 days1 visit
Treatment ~ 48 weeks17 visits
Follow Up ~ 28 days1 visit
Screening ~ 28 days
Treatment ~ 48 weeks
Follow Up ~28 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: P1101 250-350-500mcgExperimental Treatment1 Intervention
Pre-filled Syringe, Q2W starting at 250-350-500, SC injection
Group II: Ropeginterferon alfa-2b-njftActive Control1 Intervention
Pre-filled Syringe, Q2W starting at 100 up to 500 (50mcg increases), SC injection
Find a Location
Logistics
Travel, including flights, are covered
Your expenses for travel tickets for this trial will be reimbursed.
Who is running the clinical trial?
PharmaEssentiaLead Sponsor
20 Previous Clinical Trials
1,312 Total Patients Enrolled
2 Trials studying Polycythemia Vera
159 Patients Enrolled for Polycythemia Vera
Ray Urbanski, MD, PhDStudy DirectorPharmaEssentia USA Corporation
1 Previous Clinical Trials
64 Total Patients Enrolled
Ray Urbanski, MD/PhDStudy DirectorPharmaEssentia USA Corporation
1 Previous Clinical Trials
64 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I agree to use birth control during and 60 days after the study, and I won't breastfeed if participating.My liver is functioning well according to recent tests.My hemoglobin level is at least 10 g/dL if I am female, or 11 g/dL if I am male.My kidneys are functioning well enough (creatinine clearance rate ≥40 mL/min).
Research Study Groups:
This trial has the following groups:- Group 1: P1101 250-350-500mcg
- Group 2: Ropeginterferon alfa-2b-njft
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 28 Days to process to see if you qualify in this trial.
- Treatment: You will receive the treatment for 48 Weeks
- Follow Ups: You may be asked to continue sharing information regarding the trial for 28 Days after you stop receiving the treatment.
Polycythemia Vera Patient Testimony for trial: Trial Name: NCT05481151 — Phase 3
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are we still enrolling people in this clinical trial?
"This particular clinical trial, as indicated by the website clinicaltrials.gov is not currently looking for new patients to enroll. Although this study is no longer active, there are 56 other trials that may be of interest and are still recruiting individuals."
Answered by AI
What kind of side effects does Ropeginterferon alfa-2b-njft (P1101) have?
"There is some existing data to suggest the efficacy of Ropeginterferon alfa-2b-njft (P1101), which, combined with its multiple rounds of safety testing, gives it a score of 3."
Answered by AI
Are other hospitals in our state conducting this research as well?
"There are a total of 16 clinical trial sites currently running this study. The locations closest to major metropolitan areas include Toronto, Bronx, and Vancouver. If you enroll in the study, it is best to choose the location that is most convenient for you to minimize travel demands."
Answered by AI
Who else is applying?
What state do they live in?
California
New York
Other
Michigan
What site did they apply to?
American Oncology Partners of Maryland PA (Center for Cancer & Blood Disorders)
University of Michigan
Montefiore Medical Center
Other
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0
3+
2
Why did patients apply to this trial?
To sign up. Am interested in an alternative med to hydroxyurea which makes me nauseous every evening.
PatientReceived no prior treatments
On Jakafi and still require routine phlebotomies, always tired an no energy because of borderline anemic.
PatientReceived 1 prior treatment
Interested in finding out more about this clinical trial. Will you provide transportation to your Bronx site, since I live at 360 East 55 Street, NYC, NY 10022 and I won't take a subway into the South Bronx.
PatientReceived 2+ prior treatments
Diagnosed in November 2018, 51 years old. Did two blood lettings and one iron infusion. Started with anagrelide 1 mg capsule, and an aspirin every day. Switched to Hydroxyurea 500 MG in December 2021. Have gradually increased last year to 1000 mg to this year I am at 1500 mg. per day. My Jak2 gene has been tested and does not function properly. Blood and platlet tests every Friday or every other Friday. Last reading was 289 platelets and 3.37 RBC and 3.3 WBC.
PatientReceived 1 prior treatment
What questions have other patients asked about this trial?
How long does screening take and is there compensation for screening or transportation?
PatientReceived 1 prior treatment
How responsive is this trial?
Typically responds via
Phone Call
Most responsive sites:
- Baptist MD Anderson: < 48 hours
Average response time
- < 2 Days
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger