Ropeginterferon alfa-2b (P1101) for Thrombocythemia, Essential

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Thrombocythemia, Essential+2 More
Ropeginterferon alfa-2b-njft (P1101) - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

A Single-arm, Multicenter Study to Assess the Efficacy, Safety, and Tolerability of Ropeginterferon alfa-2b-njft (P1101) in Adult Patients with Essential Thrombocythemia

Eligible Conditions
  • Thrombocythemia, Essential

Treatment Effectiveness

Study Objectives

1 Primary · 0 Secondary · Reporting Duration: 12 months

12 months
To assess efficacy of ropeginterferon alfa-2b-njft (P1101) in adult USA/Canadian patients with ET

Trial Safety

Trial Design

1 Treatment Group

Ropeginterferon alfa-2b (P1101)
1 of 1

Experimental Treatment

64 Total Participants · 1 Treatment Group

Primary Treatment: Ropeginterferon alfa-2b (P1101) · No Placebo Group · Phase 2

Ropeginterferon alfa-2b (P1101)
Drug
Experimental Group · 1 Intervention: Ropeginterferon alfa-2b-njft (P1101) · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 12 months

Who is running the clinical trial?

PharmaEssentiaLead Sponsor
19 Previous Clinical Trials
1,188 Total Patients Enrolled
1 Trials studying Thrombocythemia, Essential
160 Patients Enrolled for Thrombocythemia, Essential
Ray Urbanski, MD/PhDStudy DirectorPharmaEssentia USA Corporation
1 Previous Clinical Trials
64 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 8 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are a male or female aged 18 years or older.
Subjects diagnosed with ET according to the World Health Organization (WHO) 2016 criteria.
You have not received treatment with interferon.
Creatinine clearance ≥40 mL/min (by Cockcroft-Gault equation).
Platelet count >450 × 109/L at screening.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: November 15th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.