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P1101 for Essential Thrombocythemia

Phase 2
Research Sponsored by PharmaEssentia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

Study Summary

This trialtests a new drug to treat Essential Thrombocythemia in adults, to see if it is safe, effective and well-tolerated.

Who is the study for?
Adults diagnosed with Essential Thrombocythemia (ET) as per WHO criteria, with a platelet count over 450 × 10^9/L and good liver and kidney function. Participants must be at least 18 years old, agree to use birth control, and not breastfeed during the study. Those previously treated with ANA or HU are eligible but not if they've had poor responses or intolerance to interferon alfa therapy.Check my eligibility
What is being tested?
The trial is testing Ropeginterferon alfa-2b-njft (P1101) in adults with ET to evaluate its effectiveness, safety, and how well patients tolerate it. This single-arm study means all participants will receive P1101 without comparison to another treatment.See study design
What are the potential side effects?
Potential side effects of P1101 may include reactions related to the immune system such as flu-like symptoms, fatigue, headache, muscle pain; there might also be injection site reactions or changes in blood tests that monitor liver function.


Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
To assess efficacy of ropeginterferon alfa-2b-njft (P1101) in adult USA/Canadian patients with ET

Trial Design

1Treatment groups
Experimental Treatment
Group I: Ropeginterferon alfa-2b (P1101)Experimental Treatment1 Intervention
Pre-filled Syringe, Q2W, SC injection

Find a Location

Who is running the clinical trial?

PharmaEssentiaLead Sponsor
20 Previous Clinical Trials
1,356 Total Patients Enrolled
Ray Urbanski, MD, PhDStudy DirectorPharmaEssentia USA Corporation
1 Previous Clinical Trials
100 Total Patients Enrolled
Ray Urbanski, MD/PhDStudy DirectorPharmaEssentia USA Corporation
1 Previous Clinical Trials
100 Total Patients Enrolled

Media Library

Ropeginterferon alfa-2b-njft (P1101) (Interferon) Clinical Trial Eligibility Overview. Trial Name: NCT05482971 — Phase 2
Essential Thrombocythemia Research Study Groups: Ropeginterferon alfa-2b (P1101)
Essential Thrombocythemia Clinical Trial 2023: Ropeginterferon alfa-2b-njft (P1101) Highlights & Side Effects. Trial Name: NCT05482971 — Phase 2
Ropeginterferon alfa-2b-njft (P1101) (Interferon) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05482971 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the Food and Drug Administration authorized Ropeginterferon alfa-2b (P1101) for use?

"The safety of Ropeginterferon alfa-2b (P1101) was assessed to be a 2 as this is Phase 2 trial and data has been collected supporting its security, yet no clinical trials have proven it's effectiveness."

Answered by AI

What is the current sample size of this clinical experiment?

"Affirmative. According to clinicaltrials.gov, this medical research is currently recruiting individuals; the experiment was initially posted on September 29th 2022 and modified just recently in November 9th 2022. In total 64 participants are needed from 23 sites."

Answered by AI

Is enrollment for this trial currently open to participants?

"According to clinicaltrials.gov, this research is still enrolling participants and has been since it was published on September 29th 2022. Its most recent modification was observed November 9th 2021."

Answered by AI

How many venues are actively conducting this research endeavor?

"This clinical trial is taking place at the University of Tennessee Health Science Centre in Memphis, Weill Medical College of Cornell University in New york and Juravinski Cancer Centre in Hamilton. In addition to these sites there are 20 other locations running this study."

Answered by AI

Who else is applying?

What state do they live in?
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?

Why did patients apply to this trial?

~6 spots leftby Jul 2024