search
Back to results

Study to Evaluate the Long-term Safety of Rusfertide (PTG-300) in Subjects With Polycythemia Vera (THRIVE)

Primary Purpose

Polycythemia Vera

Status
Not yet recruiting
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Open-label rusfertide
Sponsored by
Protagonist Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Polycythemia Vera

Eligibility Criteria

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

Inclusion Criteria: Subject who has completed at least 12 months of dosing with rusfertide and successfully completed the end of treatment visit of a previous Phase 2 or Phase 3 study of rusfertide. Subject understands the study procedures, is willing and able to adhere to study requirements and agrees to participate in the study by giving written informed consent. Key Exclusion Criteria: Subject who, in the opinion of the investigator, should not participate in the study. Subject who discontinue early from a previous rusfertide study for reasons other than enrolling in this study. Pregnant or lactating females. Women of childbearing potential (WOCBP) who do not agree to use medically acceptable contraception (<1% annual failure rate) during the study and for 30 days after the last dose of study drug. Men with partners of childbearing potential who do not agree to use medically acceptable contraception (<1% annual failure rate) during the study and for 90 days after the last dose of study drug. Men who do not agree to use a condom during the study and for 90 days after the last dose of study drug regardless of the partner's childbearing potential. A female subject intends to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for a period of 30 days after receiving the last dose of study drug. A male subject intends to donate sperm for the purpose of reproduction during the study and for a minimum of 90 days after receiving the last dose of study drug. Plan to use investigational treatment other than rusfertide during the course of the study or within 28 days after last rusfertide dose. Subject with hypersensitivity to rusfertide or to any of the excipients. In the investigator's opinion the subject has progressive disease that cannot be managed by adjusting concurrent cytoreductive therapy.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Open-label rusfertide

    Arm Description

    Open-label rusfertide

    Outcomes

    Primary Outcome Measures

    Hematocrit
    Median hematocrit
    Phlebotomies
    Number of phlebotomies

    Secondary Outcome Measures

    Full Information

    First Posted
    September 5, 2023
    Last Updated
    September 5, 2023
    Sponsor
    Protagonist Therapeutics, Inc.
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT06033586
    Brief Title
    Study to Evaluate the Long-term Safety of Rusfertide (PTG-300) in Subjects With Polycythemia Vera
    Acronym
    THRIVE
    Official Title
    An Extension Study to Evaluate the Long-term Safety of Rusfertide (PTG-300) in Subjects With Polycythemia Vera (THRIVE)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    December 1, 2023 (Anticipated)
    Primary Completion Date
    April 1, 2026 (Anticipated)
    Study Completion Date
    April 1, 2027 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Protagonist Therapeutics, Inc.

    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
    The goal of this clinical trial is to assess long-term safety and efficacy of rusfertide in subjects with polycythemia vera. Subjects who complete dosing with rusfertide until the end-of-treatment visit of a Phase 2 or Phase 3 study and meet the inclusion/exclusion criteria for this study, are eligible to participate in this open-label study and continue treatment with rusfertide.
    Detailed Description
    This is an open-label study designed to assess the long-term safety and efficacy of rusfertide. This study aims to provide long-term rusfertide treatment to subjects who complete dosing until the end-of-treatment of a previous Phase 2 or Phase 3 rusfertide study and are likely to continue benefiting from treatment with rusfertide based on their improved control of hematocrit levels <45% and reduced need for therapeutic phlebotomies. This study will provide long-term rusfertide treatment to these subjects and obtain data on safety and efficacy of long-term treatment with rusfertide.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Polycythemia Vera

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Single Group Assignment
    Model Description
    Open-label rusfertide
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Open-label rusfertide
    Arm Type
    Experimental
    Arm Description
    Open-label rusfertide
    Intervention Type
    Drug
    Intervention Name(s)
    Open-label rusfertide
    Intervention Description
    subcutaneous rusfertide
    Primary Outcome Measure Information:
    Title
    Hematocrit
    Description
    Median hematocrit
    Time Frame
    0-2 years
    Title
    Phlebotomies
    Description
    Number of phlebotomies
    Time Frame
    0-2 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Subject who has completed at least 12 months of dosing with rusfertide and successfully completed the end of treatment visit of a previous Phase 2 or Phase 3 study of rusfertide. Subject understands the study procedures, is willing and able to adhere to study requirements and agrees to participate in the study by giving written informed consent. Key Exclusion Criteria: Subject who, in the opinion of the investigator, should not participate in the study. Subject who discontinue early from a previous rusfertide study for reasons other than enrolling in this study. Pregnant or lactating females. Women of childbearing potential (WOCBP) who do not agree to use medically acceptable contraception (<1% annual failure rate) during the study and for 30 days after the last dose of study drug. Men with partners of childbearing potential who do not agree to use medically acceptable contraception (<1% annual failure rate) during the study and for 90 days after the last dose of study drug. Men who do not agree to use a condom during the study and for 90 days after the last dose of study drug regardless of the partner's childbearing potential. A female subject intends to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for a period of 30 days after receiving the last dose of study drug. A male subject intends to donate sperm for the purpose of reproduction during the study and for a minimum of 90 days after receiving the last dose of study drug. Plan to use investigational treatment other than rusfertide during the course of the study or within 28 days after last rusfertide dose. Subject with hypersensitivity to rusfertide or to any of the excipients. In the investigator's opinion the subject has progressive disease that cannot be managed by adjusting concurrent cytoreductive therapy.

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Study to Evaluate the Long-term Safety of Rusfertide (PTG-300) in Subjects With Polycythemia Vera

    We'll reach out to this number within 24 hrs