Blood and Lymph Conditions

All Conditions

Heart and Blood Diseases

Rare Diseases

Myeloproliferative Disorders

Thrombocytosis

Thrombocythemia, Essential

Blood Platelet Disorders

Hematologic Diseases

Bone Marrow Diseases

Hemostatic Disorders

Blood Coagulation Disorders

Hemorrhagic Disorders

Chronic Myeloproliferative Disorders

Essential Thrombocythemia

Ropeginterferon alfa-2b-njft (P1101)

Jewell Jessup, PhD

Mitch Shea

Jaime Chang

Anne Caldwell

Jennifer Steffen

Shannon Gleason

Melissa Parker

Barbie Warner

Leta Ko

Steven Schmitt

Morgan Johnson

Karyn Gordon

Layla Tapia

Stephanie Ortiz

Jason Brecher

Noelle Townsend

Zita Makselyte

Peggy Alton

Toria Wilson

Ines Hernandez

Suzhen Gong

Mary Ann Richie

Braxton Smith

Ellie Gorham

Tathiana Ruiz

Christopher Hillis

Nina Dimson

Ray Urbanski, MD, PhD

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

PharmaEssentia is developing a pegylated (PEG) IFN-α product, P1101, for the treatment of Essential Thrombocythemia (ET) as lack of disease modifying therapies in essential ET constitutes a serious issue in modern hematology.

Ropeginterferon alfa-2b-njft (P1101) may represent an effective, well-tolerated treatment with the ability to provide a deeper response and superior control of important blood parameters with the potential to alter the course of the disease and prevent progression to post-ET myelofibrosis (MF) and/or secondary acute myeloid leukemia (sAML). Ropeginterferon alfa-2b-njft (P1101) is currently being evaluated in comparison to ANA in the ongoing global Phase 3 clinical study, SURPASS ET.

Enrolled patients will receive P1101 over 13 months followed by an extension period.

A Single-arm, Multicenter Study to Assess the Efficacy, Safety, and Tolerability of P1101 in Adults With ET

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

Efficacy will be based on peripheral blood count remission as defined by hematocrit (HCT) \<45%, white blood cell (WBC) count ≤10 × 109/L, and platelets (PLT) ≤ 400 × 109/L in at least 80% of bi-weekly measurements for a consecutive 32-wek period during the 52-week core study treatment period.

PharmaEssentia

Neoplasms

Polycythemia Vera

Polycythemia

Bone Marrow Neoplasms

Hematologic Neoplasms

Pre-filled Syringe, Q2W starting at 250-350-500, SC injection

Pre-filled Syringe, Q2W starting at 100 up to 500 (50mcg increases), SC injection

P1101 (Ropeginterferon alfa-2b-njft)

Poonam Neki

Phil Hutson

Jacob Patterson

Delphine Thomas

Percy Yeung

Mikaela Dougherty

Denise Brigham

Mitchell Davidsz

Nichole Ard

Nicole Fisher

Cory Caldwell

Christopher Hillis, PhD

Dana Maassen

A Study to Assess Efficacy, Safety, and Tolerability of P1101 in Adult Patients with PV

Polycythemia vera (PV) is the most common type of chronic myeloproliferative neoplasm (MPN), with an annual reported incidence of up to 2.6/100,000. This is a long-term debilitating and life-threatening disease because it is associated with the risk of thrombosis, bleeding, and progression to myelofibrosis (MF) and secondary acute myeloid leukemia (sAML)

Ropeginterferon alfa-2b-njft (P1101), which gained US marketing authorization in November 2021, is the only interferon alfa approved for the treatment of PV.

This study aims to evaluate the efficacy, tolerability, and safety of ropeginterferon alfa-2b-njft (P1101) in US and Canadian PV patients, utilizing an optimized dosing regimen.

A Study to Assess Efficacy, Safety, and Tolerability of P1101 in Adult Patients With PV

A Phase IIIb, Randomized, Open-Label, Parallel Group, Multicenter Study to Assess Efficacy, Safety, and Tolerability of Two Dosing Regimens of Ropeginterferon Alfa-2b-njft (P1101) in Adult Patients With Polycythemia Vera (PV)

CHR is defined as hematocrit (HCT) \<45%, white blood cell (WBC) count \<10 × 10\^9/L, platelets (PLT) ≤400 × 10\^9/L in the absence of phlebotomy in the previous 12 weeks.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Single-arm, Multicenter Study to Assess the Efficacy, Safety, and Tolerability of P1101 in Adults With ET	NCT05482971	Essential Throm...	Ropeginterferon...	18 Years -	PharmaEssentia
A Study to Assess Efficacy, Safety, and Tolerability of P1101 in Adult Patients With PV	NCT05481151	Polycythemia Ve...	P1101 (Ropegint... Ropeginterferon...	18 Years -	PharmaEssentia

Spots Global Cancer Trial Database for besremi

Every month we try and update this database with for besremi cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for besremi

Every month we try and update this database with for besremi cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for besremi cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.