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PTG-300 in Patients With Polycythemia Vera and Elevated Hematocrit (PACIFIC)

Primary Purpose

Polycythemia Vera

Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
PTG-300
Sponsored by
Protagonist Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Polycythemia Vera focused on measuring PV

Eligibility Criteria

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

Inclusion Criteria:

  1. Known diagnosis of polycythemia vera.
  2. Hematocrit >48% before dosing.
  3. Evidence of hematocrit >48% three or more times in the 28 weeks before dosing or five or more times in 52 weeks before dosing (except for newly diagnosed patients).
  4. Clinically reasonable alternative causes for erythrocytosis have been evaluated and excluded.
  5. Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2.

Exclusion Criteria:

  1. Clinically significant thrombosis (e.g., deep vein thrombosis or splenic vein thrombosis) within 3 months of Screening.
  2. Active or chronic bleeding within 4 weeks of Screening.
  3. Meets the criteria for post-PV myelofibrosis as defined by the International Working Group-Myeloproliferative Neoplasms Research and Treatment (IWG-MRT).
  4. Infection requiring hospitalization or intravenous antimicrobial therapy, or opportunistic infection within 3 months of dosing; any infection requiring systemic antimicrobial therapy within 4 weeks of dosing. Prophylactic antibiotics are allowed.
  5. Any serious or unstable medical or psychiatric condition that would prevent, (as judged by the Investigator) the subject from properly providing informed consent or any condition which would jeopardize compliance with the study.
  6. Known primary or secondary immunodeficiency.
  7. Known positive for active hepatitis B, hepatitis C or human immunodeficiency virus (HIV) infection.
  8. Any surgical procedure requiring general anesthesia within 1 month prior to Screening or planned elective surgery during the study.
  9. History of invasive malignancies within the last 2 years, except non-melanoma skin cancer and localized curatively treated prostate cancer or cervical cancer.
  10. Current or recent history of alcohol dependence or illicit drug use within 1 year prior to Screening.

Sites / Locations

  • Gachon University Medical Center
  • Seoul National University Hospital
  • Seoul St. Mary's Catholic University Hospital
  • Hospital Sultanah Aminah
  • Hospital Raja Perempuan Zainab
  • Hospital Raja Permaisuki Bainun
  • Hospital Umum Sarawak
  • Hospital Ampang

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PTG-300

Arm Description

Evaluate PTG-300's efficacy and safety in subjects with PV and baseline elevated hematocrit.

Outcomes

Primary Outcome Measures

Evaluate PTG-300's efficacy in subjects with PV and baseline elevated hematocrit.
Proportion of subjects with hematocrit <45%

Secondary Outcome Measures

Safety of PTG-300
Proportion of Subjects Treatment-Emergent Adverse Events

Full Information

First Posted
February 18, 2021
Last Updated
March 8, 2022
Sponsor
Protagonist Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04767802
Brief Title
PTG-300 in Patients With Polycythemia Vera and Elevated Hematocrit
Acronym
PACIFIC
Official Title
A Phase 2 Study of the Hepcidin Mimetic PTG-300 in Patients With Polycythemia Vera and Elevated Hematocrit
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 2, 2021 (Actual)
Primary Completion Date
October 30, 2022 (Anticipated)
Study Completion Date
April 30, 2023 (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
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is an open label, single arm trial of PTG-300 in subjects with PV who are newly diagnosed or for whom current therapy is not sufficient to control their hematocrit and have hematocrit >48% prior to dosing. The PTG-300 dose and schedule may be adjusted every 2 to 4 weeks to maintain hematocrit <45% with a target of <43%. Subjects may receive PTG-300 treatment for up to 52 weeks.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PTG-300
Arm Type
Experimental
Arm Description
Evaluate PTG-300's efficacy and safety in subjects with PV and baseline elevated hematocrit.
Intervention Type
Drug
Intervention Name(s)
PTG-300
Intervention Description
Hepcidin mimetic
Primary Outcome Measure Information:
Title
Evaluate PTG-300's efficacy in subjects with PV and baseline elevated hematocrit.
Description
Proportion of subjects with hematocrit <45%
Time Frame
Estimate the proportion of subject with a hematocrit less than 45% at Week 16
Secondary Outcome Measure Information:
Title
Safety of PTG-300
Description
Proportion of Subjects Treatment-Emergent Adverse Events
Time Frame
Week 52

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Known diagnosis of polycythemia vera. Hematocrit >48% before dosing. Evidence of hematocrit >48% three or more times in the 28 weeks before dosing or five or more times in 52 weeks before dosing (except for newly diagnosed patients). Clinically reasonable alternative causes for erythrocytosis have been evaluated and excluded. Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2. Exclusion Criteria: Clinically significant thrombosis (e.g., deep vein thrombosis or splenic vein thrombosis) within 3 months of Screening. Active or chronic bleeding within 4 weeks of Screening. Meets the criteria for post-PV myelofibrosis as defined by the International Working Group-Myeloproliferative Neoplasms Research and Treatment (IWG-MRT). Infection requiring hospitalization or intravenous antimicrobial therapy, or opportunistic infection within 3 months of dosing; any infection requiring systemic antimicrobial therapy within 4 weeks of dosing. Prophylactic antibiotics are allowed. Any serious or unstable medical or psychiatric condition that would prevent, (as judged by the Investigator) the subject from properly providing informed consent or any condition which would jeopardize compliance with the study. Known primary or secondary immunodeficiency. Known positive for active hepatitis B, hepatitis C or human immunodeficiency virus (HIV) infection. Any surgical procedure requiring general anesthesia within 1 month prior to Screening or planned elective surgery during the study. History of invasive malignancies within the last 2 years, except non-melanoma skin cancer and localized curatively treated prostate cancer or cervical cancer. Current or recent history of alcohol dependence or illicit drug use within 1 year prior to Screening.
Facility Information:
Facility Name
Gachon University Medical Center
City
Incheon
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Seoul St. Mary's Catholic University Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Hospital Sultanah Aminah
City
Johor Bahru
State/Province
Johor
Country
Malaysia
Facility Name
Hospital Raja Perempuan Zainab
City
Kota Bharu
State/Province
Kelantan
Country
Malaysia
Facility Name
Hospital Raja Permaisuki Bainun
City
Ipoh
State/Province
Perak
Country
Malaysia
Facility Name
Hospital Umum Sarawak
City
Kuching
State/Province
Sarawak
Country
Malaysia
Facility Name
Hospital Ampang
City
Ampang
State/Province
Selangor
Country
Malaysia

12. IPD Sharing Statement

Plan to Share IPD
No

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PTG-300 in Patients With Polycythemia Vera and Elevated Hematocrit

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