Who is eligible for clinical trial NCT05482971?

Participants must meet protocol criteria for Essential Thrombocythemia. Confirm exact inclusion and exclusion requirements with the study coordinator.

Does clinical trial NCT05482971 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2025-08-08

A Single-arm, Multicenter Study to Assess the Efficacy, Safety, and Tolerability of P1101 in Adults With ET (NCT05482971)

🔵 Active, Not Recruiting Phase2 💊 Investigational Drug / Biologic Sponsor: PharmaEssentia

🩺 Plain-English Summary (8th-Grade Level)

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

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (9 items) and avoid the listed exclusions (21 items).

Location: University of Alabama at Birmingham — Birmingham, Alabama

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Male and female subjects ≥18 years old.
Subjects diagnosed with ET according to the World Health Organization (WHO) 2016 criteria.
Subjects that are cytoreductive treatment-naïve, or pre-exposed to HU and/or ANA, as specified below (according to Investigator's judgment and documented in the patient's medical record): a. Cytoreductive-naïve patients must be in need of cytoreductive treatment, defined as having at least one of the following: i. Progressive leukocytosis and/or thrombocytosis ii. Disease-related symptoms (i.e., pruritus, night sweats, fatigue) iii. Vasomotor/microvascular disturbances, not responsive to aspirin (including headache, chest pain or erythromelalgia, etc.) iv. High-risk (history of thrombosis at any age; or age \>60 years with JAK2 mutation) b. Patients previously exposed to HU will be classified as either: i. Documented formal HU resistance or intolerance ii. HU stopped without documented formal resistance/intolerance due to insufficient blood count control or toxicity. The last HU dose must be \>7 days prior the first dose of P1101.
Adequate hepatic function defined as bilirubin ≤1.5 × upper limit normal (ULN), prothrombin time (PT) (international normalized ratio, \[INR\]) ≤1.5 x ULN, albumin \>3.5 g/dL, alanine aminotransferase (ALT) ≤2.0 x ULN, aspartate aminotransferase ≤2.0 x ULN at screening.
Creatinine clearance ≥40 mL/min (by Cockcroft-Gault equation).
Males and females of childbearing potential, as well as all women \<2 years after the onset of menopause, must agree to use an acceptable form of birth control until 60 days following the last dose of the study drug, and females must agree to not breastfeed during the study.
Written informed consent obtained from the subject and ability for the subject to comply with the requirements of the study.
Platelet count \>450 × 109/L at screening
Both ANA-naïve and ANA-pretreated subjects are eligible for the study, regardless of the reason to terminate ANA use

Usually NOT eligible if any of the following apply:

Exclusion Criteria:
Any subject requiring a legally authorized representative
Subjects who stopped prior interferon alfa therapy due to low efficacy or poor tolerability
Any contraindications or hypersensitivity to IFN-α and/or its excipients
Co-morbidity with severe or serious condition that, in the Investigator's opinion, would jeopardize the safety of the subject or their compliance with the protocol, including significant cardiac disease (including New York Heart Association Class III-IV congestive heart failure and clinically significant arrhythmias) and pulmonary hypertension
History of major organ transplantation
Pregnant or lactating females
Subjects with any significant medical conditions that, in the opinion of the Investigator, would compromise the results of the study or may impair compliance with the requirements of the protocol, including but not limited to:
Documented autoimmune disease at screening or in the history (e.g., thyroid dysfunction, hepatitis, idiopathic thrombocytopenic purpura, scleroderma, psoriasis, or any arthritis of autoimmune origin)
Clinically relevant pulmonary infiltrates, pneumonia, and pneumonitis at screening that, in the Investigator's opinion, would jeopardize the safety of the subject or their compliance with the protocol
Infections with systemic manifestations (e.g., bacterial, fungal, or human immunodeficiency virus \[HIV\], except hepatitis B \[HBV\] and/or hepatitis C \[HCV\],at screening)
Evidence of severe retinopathy (e.g., cytomegalovirus retinitis \[CMV\], macular degeneration) or clinically relevant ophthalmological disorder (due to diabetes mellitus or hypertension)

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (34 Sites)

University of Alabama at Birmingham — Birmingham, Alabama
City of Hope National Medical Center — Duarte, California
Marin Cancer Care — Greenbrae, California
USC Norris Comprehensive Cancer Center — Los Angeles, California
Yale University School of Medicine - Yale Cancer Center — New Haven, Connecticut
Georgetown University Medical Center — Washington D.C., District of Columbia
The Winship Cancer Institute Emory University — Atlanta, Georgia
Fort Wayne Medical Oncology and Hematology — Fort Wayne, Indiana
Mercy Health - Paducah Medical Oncology and Hematology — Paducah, Kentucky
Tulane University Medical Center — New Orleans, Louisiana
Greater Baltimore Medical Center — Baltimore, Maryland
Massachusetts General Hospital — Boston, Massachusetts
Dana-Farber Cancer Institute — Boston, Massachusetts
Washington University School of Medicine - Division of Oncology — St Louis, Missouri
Cancer Care Specialists — Reno, Nevada
Astera HealthCare — East Brunswick, New Jersey
John Theurer Cancer Center At Hackensack UMC — Hackensack, New Jersey
Weill Medical College of Cornell University — New York, New York
Memorial Sloan Kettering Cancer Center — New York, New York
Stony Brook University Medical Center — Stony Brook, New York
Montefiore Medical Center — The Bronx, New York
University of North Carolina (UNC) - Lineberger Comprehensive Cancer Center — Chapel Hill, North Carolina
Duke University Medical Center — Durham, North Carolina
East Carolina University — Greenville, North Carolina
Regional Medical Oncology Center — Wilson, North Carolina

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

🏛️ View Official NIH Record ↗