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Clinical Trials List

Protocol NumberP1101 ET
NCT Number(ClinicalTrials.gov Identfier)NCT04285086
Active

2019-12-01 - 2030-05-31

Phase III

Not yet recruiting3

Recruiting20

ICD-10C88.8

Other malignant immunoproliferative diseases

ICD-10C94.40

Acute panmyelosis with myelofibrosis not having achieved remission

ICD-10C94.41

Acute panmyelosis with myelofibrosis, in remission

ICD-10C94.42

Acute panmyelosis with myelofibrosis, in relapse

ICD-10C94.6

Myelodysplastic disease, not classified

ICD-10D46.9

Myelodysplastic syndrome, unspecified

ICD-10D46.A

Refractory cytopenia with multilineage dysplasia

ICD-10D46.B

Refractory cytopenia with multilineage dysplasia and ring sideroblasts

ICD-10D46.C

Myelodysplastic syndrome with isolated del(5q) chromosomal abnormality

ICD-10D46.Z

Other myelodysplastic syndromes

ICD-10D47.1

Chronic myeloproliferative disease

ICD-10D47.3

Essential (hemorrhagic) thrombocythemia

ICD-10D47.9

Neoplasm of uncertain behavior of lymphoid, hematopoietic and related tissue, unspecified

ICD-10D47.Z1

Post-transplant lymphoproliferative disorder (PTLD)

ICD-10D47.Z9

Other specified neoplasms of uncertain behavior of lymphoid, hematopoietic and related tissue

ICD-9238.7

Neoplasm of uncertain behavior of other lymphatic and hematopoietic tissues

A Phase 3, Open-Label, Multicenter, Randomized, Active-controlled Study to Assess Pharmacokinetics and Compare the Efficacy, Safety, and Tolerability of P1101 vs Anagrelide as Second Line Therapy for Essential Thrombocythemia

  • Trial Applicant

  • Sponsor

    PharmaEssentia

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator Lee-Yung Shin Division of Hematology & Oncology
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 黃慈恩 Division of Hematology & Oncology
Chiayi Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 馬銘君 Division of Hematology & Oncology
Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator Ting-An Lin Division of Hematology & Oncology
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 林建鴻 Division of Hematology & Oncology
MacKay Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator 陳宇欽 Division of Hematology & Oncology
Tri-Service General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Su-Peng Yeh Division of Hematology & Oncology
China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Tsai-Yun Chen Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator HSIN-AN HOU Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator Hui-Hua Hsiao Division of Hematology & Oncology
Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 吳懿峰 Division of Hematology & Oncology
Hualien Tzu Chi Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 蘇裕傑 Division of Hematology & Oncology
E-DA Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 李育庭 Division of Hematology & Oncology
Chia-Yi Christian Hosptal

Co-Principal Investigator

  • 李明陽 Division of Hematology & Oncology

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 陳彥勳 Division of Hematology & Oncology
Chi Mei Hospital, Liouying

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 吳鴻昌 Division of Hematology & Oncology
Chi Mei Medical Center

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 賴泓誌 Division of Hematology & Oncology
Shin Kong Memorial Wu Ho-Su Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 洪英中 Division of Hematology & Oncology
Kaohsiung Veterans General Hosptial

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 裴松南 Division of Hematology & Oncology
E-DA Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 余垣斌 Division of Hematology & Oncology
Far Eastern Memorial Hospital

Co-Principal Investigator

  • 林世強 Division of Hematology & Oncology

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Tzeon-jye Chiou Division of Hematology & Oncology
Taipei WanFang Hospital (Managed by Taipei Medical Univeristy)

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 林明賢 Division of Hematology & Oncology
An Nan Hospital-China Medical Univeristy

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 林建鴻 Division of Hematology & Oncology
MacKay Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 吳鴻昌 Division of Hematology & Oncology
Chi Mei Medical Center

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Essential Thrombocythemia

Objectives

This is a Phase 3 open-label, multicenter, randomized, active-controlled study designed to compare the efficacy and safety and tolerability of P1101 compared with ANA after 12 months of treatment as second-line therapy for subjects with ET who have had a suboptimal or failed response to HU.PharmaEssentia Corporation is developing a pegylated (PEG) IFN-α product, P1101, for the treatment of ET.Available clinical data and experience with P1101 in PV shows that the compound, with proper dose modifications, is effective in controlling disease in a significant proportion of subjects with ET. Further, its increased serum half-life presents distinct advantages for ET treatment over that of standard IFN-α and other available PEG IFN-α therapy. This pivotal Phase 3 study will establish the efficacy and safety of P1101 in ET subjects.The enrolled subjects will be randomized into two arms, the test arm is P1101, the control arm is ANA. The overall duration for each eligible patient is 14 months, including screening (1 month), treatment (12 months) and follow-up (1 month) period. Efficacy evaluations, safety assessments, and PK and immunogenicity evaluations of P1101 will be performed.Evaluation of efficacy will include clinical laboratory assessments, allelic burden measurements of CALR, JAK-2, and MPL, spleen size measurements, bone marrow sampling, EQ-5D-3L, and MPN-SAF TSS completion.Evaluation of safety will include assessing vital signs, clinical safety laboratory tests, physical examinations, ECG evaluation, heart ECHO, lung X-ray, ECOG performance status, ocular examination, and AEs.

Test Drug

Ropeginterferon alfa-2b (P1101)

Active Ingredient

Ropeginterferon alfa-2b

Dosage Form

Pre-filled syringe

Dosage

500

Endpoints

Primary Outcome Measures :
Peripheral blood count remission [ Time Frame: month 9 and month 12 ]
platelets ≤400 x 109/L AND white blood cells (WBC) <9.5 x 109/L

Improvement or non-progression in disease-related signs [ Time Frame: month 9 and month 12 ]
splenomegaly

Large symptoms improvement or maintain non-progression [ Time Frame: month 9 and month 12 ]
based on the Myeloproliferative Neoplasm Symptom Assessment Form Total Symptom Score (MPN-SAF TSS)

Absence of hemorrhagic or thrombotic events [ Time Frame: month 9 and month 12 ]
absence of hemorrhagic or thrombotic events


Secondary Outcome Measures :
Durable response [ Time Frame: month 3 and month 6 ]
measure durable response at month 3 and 6

Longitudinal rate [ Time Frame: over the 12 months ]
measure longitudinal rate of change in the ELN response rates over the 12 months

Response rates [ Time Frame: 3, 6, 9, and 12 months ]
measure response rate based on peripheral blood count remission, no signs of progressive disease, and absence of any hemorrhagic or thrombotic events

Occurrence of thromboembolic events [ Time Frame: over the 12 months ]
measure occurrence of thromboembolic events over the 12 months

Time to first peripheral blood count remission response [ Time Frame: over the 12 months ]
measure time to first peripheral blood count remission response over the 12 months

Duration of peripheral blood count remission response [ Time Frame: over the 12 months ]
measure duration of peripheral blood count remission response over the 12 months

Symptomatic improvement assessed by the EuroQOL 5 dimensions 3 level version (EQ-5D-3L) questionnaire [ Time Frame: over the 12 months ]
measure symptomatic improvement assessed by the EuroQOL 5 dimensions 3 level version (EQ-5D-3L) questionnaire over the 12 months

Symptomatic improvement assessed by the 10-item MPN-SAF TSS [ Time Frame: over the 12 months ]
measure symptomatic improvement assessed by the 10-item MPN-SAF TSS over the 12 months

Change of CALR, MPL, and JAK-2 allelic burden over time [ Time Frame: over the 12 months ]
measure change of CALR, MPL, and JAK-2 allelic burden over time

Improvement or non-progression of spleen size assessment [ Time Frame: over the 12 months ]
measure spleen size over time

Inclution Criteria

Inclusion Criteria:

Male or female subjects ≥18 years old
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
Subjects have received prior HU for ET, while the washout between the last dose of HU and the screening visit should not be shorter than 14 days
Interferon treatment-naïve
Documented resistance/intolerance to prior HU for ET, as defined by modified ELN criteria (Barosi, et al, 2007), whereby at least one of the following criteria is met:

Platelet count >600 x 109/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 109/L and WBC count <2.5 x 109/L at any dose and any duration of HU, or Platelet count >400 x 109/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)

Platelets >450 x 109/L at screening
WBC >10 x 109/L at screening
HGB ≥11 g/dL at screening for males and 10 g/dL at screening for females
Neutrophil count ≥1.0 x 109/L at screening
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
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 28 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

Exclusion Criteria

Exclusion Criteria:

Any subject requiring a legally authorized representative
Any contraindications or hypersensitivity to IFN-α or ANA and their excipients
Known risk factors for QT-prolongation (e.g., congenital long QT, known history of acquired QT-prolongations). Medications that can prolong QTc and induce hypokalemia will not be allowed in the study.
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 other 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, macular degeneration) or clinically relevant ophthalmological disorder (due to diabetes mellitus or hypertension)
History or presence of clinically relevant depression, or previous suicide attempts or at any risk of suicide at screening, in the judgement of the Investigator
History or presence of clinically significant neurodegenerative diseases
History of any malignancy within 5 years (except Stage 0 chronic lymphocytic leukemia, basal cell, squamous cell, and superficial melanoma)
History of alcohol or drug abuse within the last year
History or evidence of any other MPN
Use of any investigational drug <4 weeks prior to the first dose of study drug or not recovered from effects of prior administration of any investigational agent
Subjects with documented ANA resistance or intolerance (see Appendix 8 for definition).

The Estimated Number of Participants

  • Taiwan

    40 participants

  • Global

    168 participants

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