Ropeginterferon Alfa-2b (P1101) vs. Anagrelide in Essential Thrombocythemia Patients With Hydroxyurea Resistance or Intolerance (NCT04285086)

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).

1. Male or female subjects ≥18 years old
2. Subjects diagnosed with high-risk ET (either older than 60 years and JAK2V617-positive at screening, or having disease-related thrombosis or hemorrhage in the past), diagnosed according to the World Health Organization (WHO) 2016 criteria
3. Subjects have received prior HU for ET, while the washout between the last dose of HU and randomization should not be shorter than 7 days
4. Interferon treatment-naïve, or anti-P1101 binding antibody negative at screening and the washout between last dose of interferon and randomization should not be shorter than 14 days.
5. Documented resistance/intolerance to prior HU for ET, referencing modified ELN criteria (Barosi, et al, 2007), whereby at least one of the following criteria is met: Platelet count \>600 x 10\^9/L at ≥2 g/day (or ≥2.5 g/day if subject body weight \>80 kg) or maximally tolerated dose if \<2 g/day after at least 3 months of HU, or Platelet count \>400 x 10\^9/L and WBC count \<2.5 x 10\^9/L at any dose and any duration of HU, or Platelet count \>400 x 10\^9/L and hemoglobin (HGB) \<10 g/dL at any dose and any duration of HU, or Presence of HU-related toxicities at any dose and any duration of therapy (e.g., leg ulcers, mucocutaneous manifestations, pneumonitis, or HU-related fever), or Platelet count \>450 x 10\^9/L at any dose and any duration of HU. The actual dose and duration of HU must be recorded on the eCRF. Moreover, if patient received one dose of HU, the reason why subject was judged to be HU resistance/intolerance must be recorded on the eCRF.
6. Platelets \>450 x 10\^9/L at screening
7. WBC \>10 x 10\^9/L at screening
8. HGB ≥11 g/dL at screening for males and 10 g/dL at screening for females
9. Neutrophil count ≥1.0 x 10\^9/L at screening
10. Adequate hepatic function defined as bilirubin ≤1.5 x upper limit normal (ULN), prothrombin time (PT) (international normalized ratio, INR) ≤1.5 x ULN, albumin \>3.5 g/dL, alanine aminotransferase ≤2.0 x ULN, aspartate aminotransferase ≤2.0 x ULN at screening
11. Creatinine clearance ≥40 mL/min (by Cockcroft-Gault equation)
12. 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 28 days following the last dose of the study drug, and females must agree to not breastfeed during the study

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

📍 All Participating Trial Locations (67 Sites)

• Mayo Clinic - Scottsdale — Scottsdale, Arizona
• Washington University School of Medicine - Division of Oncology — St Louis, Missouri
• MD Anderson Cancer Center — Houston, Texas
• University of Utah — Salt Lake City, Utah
• St. Paul's Hospital — Vancouver, British Columbia
• Princess Margaret Hospital — Toronto, Ontario
• Jewish General Hospital — Montreal, Quebec
• Peking Union Medical College Hospital — Beijing, Beijing Municipality
• Peking University People's Hospital — Beijing, Beijing Municipality
• The First Affiliated Hospital, Chongqing Medical University — Chongqing, Chongqing Municipality
• NanFang Hospital of Southern Medical University — Guangzhou, Guangdong
• Union Hospital Tongji Medical College Huazhong University of Science and Technolog — Wuhan, Hubei
• Zhongnan Hospital of Wuhan University — Wuhan, Hubei
• The First Affiliated Hospital of Soochow University — Suzhou, Jiangsu
• Shengjing Hospital of China Medical University — Shenyang, Liaoning
• Shaanxi Provincial People's Hospital — Xi'an, Shaanxi
• Qilu Hospital of Shandong University — Jinan, Shandong
• Ruijin Hospital affiliated to Shanghai Jiao Tong University school of Medicine — Shanghai, Shanghai Municipality
• West China Hospital, Sichuan University — Chengdu, Sichuan
• The Second Hospital of Tianjin Medical University — Tianjin, Tianjin Municipality
• Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences — Tianjin, Tianjin Municipality
• The First Affiliated Hospital, College of Medicine, Zhejiang University — Hangzhou, Zhejiang
• Queen Mary Hospital — Hong Kong,
• Ehime University Hospital — Tōon, Ehime
• Kitasato University Hospital — Sagamihara, Kanagawa

💰 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.