search
Back to results

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

Primary Purpose

Essential Thrombocythemia

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Ropeginterferon alfa-2b
Anagrelide
Sponsored by
PharmaEssentia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Essential Thrombocythemia focused on measuring Essential Thrombocythemia, Ropeginterferon, P1101, PharmaEssentia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  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 14 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
  13. Written informed consent obtained from the subject and ability for the subject to comply with the requirements of the study

Exclusion Criteria:

  1. Any subject requiring a legally authorized representative
  2. Any contraindications or hypersensitivity to IFN-α or ANA and their excipients
  3. 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.
  4. 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
  5. History of major organ transplantation
  6. Pregnant or lactating females
  7. 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:

    1. 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)
    2. 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
    3. Infections with systemic manifestations (e.g., bacterial, fungal, or human immunodeficiency virus [HIV], except hepatitis B [HBV] and/or hepatitis C [HCV], at screening)
    4. Evidence of severe retinopathy (e.g., cytomegalovirus retinitis, macular degeneration) or clinically relevant ophthalmological disorder (due to diabetes mellitus or hypertension)
    5. 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
    6. History or presence of clinically significant neurodegenerative diseases
    7. History of any malignancy within 5 years (except Stage 0 chronic lymphocytic leukemia, basal cell, squamous cell, and superficial melanoma)
    8. History of alcohol or drug abuse within the last year
    9. History or evidence of any other MPN
  8. 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
  9. Subjects with documented ANA resistance or intolerance (see Appendix 8 for definition).

Sites / Locations

  • Mayo ClinicRecruiting
  • University of Kansas Cancer CenterRecruiting
  • Washington University School of Medicine - Division of OncologyRecruiting
  • Mount Sinai Medical CenterRecruiting
  • Weill Medical College of Cornell UniversityRecruiting
  • MD Anderson Cancer CenterRecruiting
  • University of Texas Health Science Center at San AntonioRecruiting
  • University of UtahRecruiting
  • Froedtert Hospital and Medical College of WisconsinRecruiting
  • St. Paul's HospitalRecruiting
  • Princess Margaret Hospital
  • Jewish General Hospital
  • Peking Union Medical College HospitalRecruiting
  • Peking University People's HospitalRecruiting
  • The First Affiliated Hospital, Chongqing Medical UniversityRecruiting
  • NanFang Hospital of Southern Medical UniversityRecruiting
  • Union Hospital Tongji Medical College Huazhong University of Science and TechnologRecruiting
  • Zhongnan Hospital of Wuhan UniversityRecruiting
  • The First Affiliated Hospital of Soochow UniversityRecruiting
  • Shengjing Hospital of China Medical UniversityRecruiting
  • Shaanxi Provincial People's HospitalRecruiting
  • Qilu Hospital of Shandong UniversityRecruiting
  • Ruijin Hospital affiliated to Shanghai Jiao Tong University school of MedicineRecruiting
  • West China Hospital, Sichuan UniversityRecruiting
  • Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical SciencesRecruiting
  • The First Affiliated Hospital, College of Medicine, Zhejiang UniversityRecruiting
  • Queen Mary HospitalRecruiting
  • Ehime University HospitalRecruiting
  • Kitasato University HospitalRecruiting
  • Mie University HospitalRecruiting
  • University of Miyazaki HospitalRecruiting
  • Kansai Medical University HospitalRecruiting
  • Kindai University HospitalRecruiting
  • Osaka University HospitalRecruiting
  • Juntendo University Shizuoka HospitalRecruiting
  • Juntendo University HospitalRecruiting
  • Nippon Medical School HospitalRecruiting
  • NTT Medical Center TokyoRecruiting
  • Tokyo Medical University HospitalRecruiting
  • University of Yamanashi HospitalRecruiting
  • Gachon University Gil Medical CenterRecruiting
  • Seoul National University HospitalRecruiting
  • Severance Hospital, Yonsei University Health SystemRecruiting
  • SoonChunHyang University Seoul HospitalRecruiting
  • Konkuk University HospitalRecruiting
  • Samsung Medical CenterRecruiting
  • Seoul St. Mary's Hospital, The Catholic University of KoreaRecruiting
  • Korea University Guro HospitalRecruiting
  • National University HospitalRecruiting
  • Singapore General HospitalRecruiting
  • Chiayi Chang Gung Memorial HospitalRecruiting
  • Hualien Tzu Chi Hospital
  • Kaohsiung Medical University Chung-Ho Memorial HospitalRecruiting
  • Kaohsiung Chang Gung Memorial HospitalRecruiting
  • China Medical University HospitalRecruiting
  • National Cheng Kung University HospitalRecruiting
  • National Taiwan University HospitalRecruiting
  • Mackay Memorial HospitalRecruiting
  • Taipei Veterans General HospitalRecruiting
  • Tri-Service General HospitalRecruiting
  • Linkou Chang Gung Memorial HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Ropeginterferon alfa-2b (P1101)

Anagrelide

Arm Description

Pre-filled Syringe, Q2W, SC injection

Capsules, Daily, p.o.

Outcomes

Primary Outcome Measures

Peripheral blood count remission
platelets ≤400 x 10^9/L AND white blood cells (WBC) <9.5 x 10^9/L
Improvement or non-progression in disease-related signs
splenomegaly
Large symptoms improvement or maintain non-progression
based on the Myeloproliferative Neoplasm Symptom Assessment Form Total Symptom Score (MPN-SAF TSS)
Absence of hemorrhagic or thrombotic events
absence of hemorrhagic or thrombotic events

Secondary Outcome Measures

Durable response
measure durable response at month 3 and 6
Longitudinal rate
measure longitudinal rate of change in the ELN response rates over the 12 months
Response rates
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
measure occurrence of thromboembolic events over the 12 months
Time to first peripheral blood count remission response
measure time to first peripheral blood count remission response over the 12 months
Duration of peripheral blood count remission response
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
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
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
measure change of CALR, MPL, and JAK-2 allelic burden over time
Improvement or non-progression of spleen size assessment
measure spleen size over time

Full Information

First Posted
February 23, 2020
Last Updated
December 30, 2021
Sponsor
PharmaEssentia
Collaborators
Medpace, Inc., EPS International, Brightech International
search

1. Study Identification

Unique Protocol Identification Number
NCT04285086
Brief Title
Ropeginterferon Alfa-2b (P1101) vs. Anagrelide in Essential Thrombocythemia Patients With Hydroxyurea Resistance or Intolerance
Acronym
SURPASS ET
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Recruiting
Study Start Date
August 25, 2020 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
January 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
PharmaEssentia
Collaborators
Medpace, Inc., EPS International, Brightech International

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Essential Thrombocythemia
Keywords
Essential Thrombocythemia, Ropeginterferon, P1101, PharmaEssentia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Experimental Drug (Biological): Ropeginterferon alfa-2b (P1101), Q2W, SC injection Control Drug: Anagrelide, capsules, daily, p.o.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ropeginterferon alfa-2b (P1101)
Arm Type
Experimental
Arm Description
Pre-filled Syringe, Q2W, SC injection
Arm Title
Anagrelide
Arm Type
Active Comparator
Arm Description
Capsules, Daily, p.o.
Intervention Type
Biological
Intervention Name(s)
Ropeginterferon alfa-2b
Other Intervention Name(s)
P1101
Intervention Description
Ropeginterferon alfa-2b (P1101) dosage: from 250 mcg to 500 mcg
Intervention Type
Drug
Intervention Name(s)
Anagrelide
Intervention Description
Anagrelide dosage: 0.5 mg per capsule, according to label and physician's judgement
Primary Outcome Measure Information:
Title
Peripheral blood count remission
Description
platelets ≤400 x 10^9/L AND white blood cells (WBC) <9.5 x 10^9/L
Time Frame
month 9 and month 12
Title
Improvement or non-progression in disease-related signs
Description
splenomegaly
Time Frame
month 9 and month 12
Title
Large symptoms improvement or maintain non-progression
Description
based on the Myeloproliferative Neoplasm Symptom Assessment Form Total Symptom Score (MPN-SAF TSS)
Time Frame
month 9 and month 12
Title
Absence of hemorrhagic or thrombotic events
Description
absence of hemorrhagic or thrombotic events
Time Frame
month 9 and month 12
Secondary Outcome Measure Information:
Title
Durable response
Description
measure durable response at month 3 and 6
Time Frame
month 3 and month 6
Title
Longitudinal rate
Description
measure longitudinal rate of change in the ELN response rates over the 12 months
Time Frame
over the 12 months
Title
Response rates
Description
measure response rate based on peripheral blood count remission, no signs of progressive disease, and absence of any hemorrhagic or thrombotic events
Time Frame
3, 6, 9, and 12 months
Title
Occurrence of thromboembolic events
Description
measure occurrence of thromboembolic events over the 12 months
Time Frame
over the 12 months
Title
Time to first peripheral blood count remission response
Description
measure time to first peripheral blood count remission response over the 12 months
Time Frame
over the 12 months
Title
Duration of peripheral blood count remission response
Description
measure duration of peripheral blood count remission response over the 12 months
Time Frame
over the 12 months
Title
Symptomatic improvement assessed by the EuroQOL 5 dimensions 3 level version (EQ-5D-3L) questionnaire
Description
measure symptomatic improvement assessed by the EuroQOL 5 dimensions 3 level version (EQ-5D-3L) questionnaire over the 12 months
Time Frame
over the 12 months
Title
Symptomatic improvement assessed by the 10-item MPN-SAF TSS
Description
measure symptomatic improvement assessed by the 10-item MPN-SAF TSS over the 12 months
Time Frame
over the 12 months
Title
Change of CALR, MPL, and JAK-2 allelic burden over time
Description
measure change of CALR, MPL, and JAK-2 allelic burden over time
Time Frame
over the 12 months
Title
Improvement or non-progression of spleen size assessment
Description
measure spleen size over time
Time Frame
over the 12 months
Other Pre-specified Outcome Measures:
Title
Bone marrow histological remission
Description
the disappearance of megakaryocyte hyperplasia and absence of >grade 1 reticulin fibrosis
Time Frame
over the 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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 randomization should not be shorter than 14 days 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. 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. Platelets >450 x 10^9/L at screening WBC >10 x 10^9/L at screening HGB ≥11 g/dL at screening for males and 10 g/dL at screening for females Neutrophil count ≥1.0 x 10^9/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: 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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Toshiaki Sato, MD/PhD
Phone
+81 3 68669531
Email
toshiaki_sato@pharmaessentia.com
First Name & Middle Initial & Last Name or Official Title & Degree
TingFang Wang, MS/MHA
Phone
+886 2 26557688
Ext
7890
Email
tingfang_wang@pharmaessentia.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Toshiaki Sato, MD/PhD
Organizational Affiliation
PharmaEssentia Japan K.K.
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Craig Zimmerman, PhD
Organizational Affiliation
PharmaEssentia USA Corp.
Official's Role
Study Director
Facility Information:
Facility Name
Mayo Clinic
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85054
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical Trials Office All Mayo Clinic Locations
Phone
855-776-0015
First Name & Middle Initial & Last Name & Degree
Jeanne Palmer, MD
Facility Name
University of Kansas Cancer Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adam Al Douri
Email
aaldouri@kumc.edu
First Name & Middle Initial & Last Name & Degree
Abdulraheem Yacoub, MD
Facility Name
Washington University School of Medicine - Division of Oncology
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karyn Gordon
Email
kdgordon@wustl.edu
First Name & Middle Initial & Last Name & Degree
Stephen Oh, MD
Facility Name
Mount Sinai Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lonette Sandy
Email
lonette.sandy@mssm.edu
First Name & Middle Initial & Last Name & Degree
John Mascarenhas, MD
Facility Name
Weill Medical College of Cornell University
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amy Lam
Email
aml7017@med.cornell.edu
First Name & Middle Initial & Last Name & Degree
Ghaith Abu-Zeinah, MD
Facility Name
MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nichole Ard
Email
nard@mdanderson.org
First Name & Middle Initial & Last Name & Degree
Srdan Verstovsek, MD
Facility Name
University of Texas Health Science Center at San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tracy Rodriguez
Email
RodriguezT1@uthscsa.edu
First Name & Middle Initial & Last Name & Degree
Ruben Mesa, MD
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karen Pena
Email
karen.pena@hci.utah.edu
First Name & Middle Initial & Last Name & Degree
Tashi Tsewang, MD
Facility Name
Froedtert Hospital and Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paulette Jacobs
Email
pjacobs@mcw.edu
First Name & Middle Initial & Last Name & Degree
Laura Michaelis, MD
Facility Name
St. Paul's Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 1Y6
Country
Canada
Individual Site Status
Recruiting
Facility Name
Princess Margaret Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2C1
Country
Canada
Individual Site Status
Not yet recruiting
Facility Name
Jewish General Hospital
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada
Individual Site Status
Not yet recruiting
Facility Name
Peking Union Medical College Hospital
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Recruiting
Facility Name
Peking University People's Hospital
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Recruiting
Facility Name
The First Affiliated Hospital, Chongqing Medical University
City
Chongqing
State/Province
Chongqing
Country
China
Individual Site Status
Recruiting
Facility Name
NanFang Hospital of Southern Medical University
City
Guangzhou
State/Province
Guangdong
Country
China
Individual Site Status
Recruiting
Facility Name
Union Hospital Tongji Medical College Huazhong University of Science and Technolog
City
Wuhan
State/Province
Hubei
Country
China
Individual Site Status
Recruiting
Facility Name
Zhongnan Hospital of Wuhan University
City
Wuhan
State/Province
Hubei
Country
China
Individual Site Status
Recruiting
Facility Name
The First Affiliated Hospital of Soochow University
City
Suzhou
State/Province
Jiangsu
Country
China
Individual Site Status
Recruiting
Facility Name
Shengjing Hospital of China Medical University
City
Shenyang
State/Province
Liaoning
Country
China
Individual Site Status
Recruiting
Facility Name
Shaanxi Provincial People's Hospital
City
Xi'an
State/Province
Shaanxi
Country
China
Individual Site Status
Recruiting
Facility Name
Qilu Hospital of Shandong University
City
Jinan
State/Province
Shandong
Country
China
Individual Site Status
Recruiting
Facility Name
Ruijin Hospital affiliated to Shanghai Jiao Tong University school of Medicine
City
Shanghai
State/Province
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Name
West China Hospital, Sichuan University
City
Chengdu
State/Province
Sichuan
Country
China
Individual Site Status
Recruiting
Facility Name
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences
City
Tianjin
State/Province
Tianjin
Country
China
Individual Site Status
Recruiting
Facility Name
The First Affiliated Hospital, College of Medicine, Zhejiang University
City
Hangzhou
State/Province
Zhejiang
Country
China
Individual Site Status
Recruiting
Facility Name
Queen Mary Hospital
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Name
Ehime University Hospital
City
Toon
State/Province
Ehime
ZIP/Postal Code
791-0204
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kitasato University Hospital
City
Sagamihara
State/Province
Kanagawa
ZIP/Postal Code
252-0329
Country
Japan
Individual Site Status
Recruiting
Facility Name
Mie University Hospital
City
Tsu
State/Province
Mie
ZIP/Postal Code
514-8507
Country
Japan
Individual Site Status
Recruiting
Facility Name
University of Miyazaki Hospital
City
Miyazaki City
State/Province
Miyazaki
ZIP/Postal Code
889-1692
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kansai Medical University Hospital
City
Hirakata
State/Province
Osaka
ZIP/Postal Code
573-1191
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kindai University Hospital
City
Osakasayama
State/Province
Osaka
ZIP/Postal Code
589-8511
Country
Japan
Individual Site Status
Recruiting
Facility Name
Osaka University Hospital
City
Suita
State/Province
Osaka
ZIP/Postal Code
565-0871
Country
Japan
Individual Site Status
Recruiting
Facility Name
Juntendo University Shizuoka Hospital
City
Izunokuni
State/Province
Shizuoka
ZIP/Postal Code
410-2295
Country
Japan
Individual Site Status
Recruiting
Facility Name
Juntendo University Hospital
City
Bunkyo City
State/Province
Tokyo
ZIP/Postal Code
113-8431
Country
Japan
Individual Site Status
Recruiting
Facility Name
Nippon Medical School Hospital
City
Bunkyo City
State/Province
Tokyo
ZIP/Postal Code
113-8603
Country
Japan
Individual Site Status
Recruiting
Facility Name
NTT Medical Center Tokyo
City
Shinagawa City
State/Province
Tokyo
ZIP/Postal Code
141-0022
Country
Japan
Individual Site Status
Recruiting
Facility Name
Tokyo Medical University Hospital
City
Shinjuku City
State/Province
Tokyo
ZIP/Postal Code
160-0023
Country
Japan
Individual Site Status
Recruiting
Facility Name
University of Yamanashi Hospital
City
Chuo
State/Province
Yamanashi
ZIP/Postal Code
409-3898
Country
Japan
Individual Site Status
Recruiting
Facility Name
Gachon University Gil Medical Center
City
Incheon
ZIP/Postal Code
21565
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Severance Hospital, Yonsei University Health System
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
SoonChunHyang University Seoul Hospital
City
Seoul
ZIP/Postal Code
04401
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Konkuk University Hospital
City
Seoul
ZIP/Postal Code
05030
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Seoul St. Mary's Hospital, The Catholic University of Korea
City
Seoul
ZIP/Postal Code
06591
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Korea University Guro Hospital
City
Seoul
ZIP/Postal Code
08308
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
National University Hospital
City
Singapore
ZIP/Postal Code
119074
Country
Singapore
Individual Site Status
Recruiting
Facility Name
Singapore General Hospital
City
Singapore
ZIP/Postal Code
169608
Country
Singapore
Individual Site Status
Recruiting
Facility Name
Chiayi Chang Gung Memorial Hospital
City
Puzi City
State/Province
Chiayi County
ZIP/Postal Code
61363
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Hualien Tzu Chi Hospital
City
Hualien City
ZIP/Postal Code
97002
Country
Taiwan
Individual Site Status
Not yet recruiting
Facility Name
Kaohsiung Medical University Chung-Ho Memorial Hospital
City
Kaohsiung City
ZIP/Postal Code
80756
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Kaohsiung Chang Gung Memorial Hospital
City
Kaohsiung City
ZIP/Postal Code
83301
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
China Medical University Hospital
City
Taichung City
ZIP/Postal Code
40447
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
National Cheng Kung University Hospital
City
Tainan City
ZIP/Postal Code
70403
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
National Taiwan University Hospital
City
Taipei City
ZIP/Postal Code
10002
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Mackay Memorial Hospital
City
Taipei City
ZIP/Postal Code
10449
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Taipei Veterans General Hospital
City
Taipei City
ZIP/Postal Code
11217
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Tri-Service General Hospital
City
Taipei City
ZIP/Postal Code
11449
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Linkou Chang Gung Memorial Hospital
City
Taoyuan City
ZIP/Postal Code
33305
Country
Taiwan
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35924546
Citation
Verstovsek S, Komatsu N, Gill H, Jin J, Lee SE, Hou HA, Sato T, Qin A, Urbanski R, Shih W, Zagrijtschuk O, Zimmerman C, Mesa RA. SURPASS-ET: phase III study of ropeginterferon alfa-2b versus anagrelide as second-line therapy in essential thrombocythemia. Future Oncol. 2022 Sep;18(27):2999-3009. doi: 10.2217/fon-2022-0596. Epub 2022 Aug 4.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs