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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
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
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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
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My liver is functioning well according to recent tests.I am not allergic to IFN-α or its ingredients.I haven't had treatment to reduce my blood cell counts, or I've only had hydroxyurea and/or anagrelide.I agree to use birth control during and up to 60 days after the study, and I won't breastfeed if participating.I have or have not been treated with ANA before, regardless of why I stopped.I agree to use birth control during and for 60 days after the study, and I won't breastfeed if participating.I need someone legally authorized to make decisions for me.I stopped taking interferon alfa because it didn't work well or had bad side effects.My condition is officially diagnosed as Essential Thrombocythemia.My kidneys are working well enough (creatinine clearance ≥40 mL/min).I have been diagnosed with Essential Thrombocythemia according to WHO standards.I have had a major organ transplant.I am 18 years old or older.My liver tests are within normal ranges.I am 18 years old or older.I have never been treated with interferon.
Research Study Groups:
This trial has the following groups:- Group 1: Ropeginterferon alfa-2b (P1101)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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?
Washington
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
1
Why did patients apply to this trial?
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