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

Sponsor
Protagonist Therapeutics, Inc. (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04767802
Collaborator
(none)
20
8
1
26.8
2.5
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Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 2 Study of the Hepcidin Mimetic PTG-300 in Patients With Polycythemia Vera and Elevated Hematocrit
Actual Study Start Date :
Feb 2, 2021
Anticipated Primary Completion Date :
Oct 30, 2022
Anticipated Study Completion Date :
Apr 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: PTG-300

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

Drug: PTG-300
Hepcidin mimetic

Outcome Measures

Primary Outcome Measures

  1. Evaluate PTG-300's efficacy in subjects with PV and baseline elevated hematocrit. [Estimate the proportion of subject with a hematocrit less than 45% at Week 16]

    Proportion of subjects with hematocrit <45%

Secondary Outcome Measures

  1. Safety of PTG-300 [Week 52]

    Proportion of Subjects Treatment-Emergent Adverse Events

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Gachon University Medical Center Incheon Korea, Republic of
2 Seoul National University Hospital Seoul Korea, Republic of
3 Seoul St. Mary's Catholic University Hospital Seoul Korea, Republic of
4 Hospital Sultanah Aminah Johor Bahru Johor Malaysia
5 Hospital Raja Perempuan Zainab Kota Bharu Kelantan Malaysia
6 Hospital Raja Permaisuki Bainun Ipoh Perak Malaysia
7 Hospital Umum Sarawak Kuching Sarawak Malaysia
8 Hospital Ampang Ampang Selangor Malaysia

Sponsors and Collaborators

  • Protagonist Therapeutics, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Protagonist Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT04767802
Other Study ID Numbers:
  • PTG-300-08
First Posted:
Feb 23, 2021
Last Update Posted:
Mar 24, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Keywords provided by Protagonist Therapeutics, Inc.
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 24, 2022