PTG-300 in Patients With Polycythemia Vera and Elevated Hematocrit

Polycythemia Vera Clinical Trial

— PACIFIC  

Official title:

A Phase 2 Study of the Hepcidin Mimetic PTG-300 in Patients With Polycythemia Vera and Elevated Hematocrit (PACIFIC)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04767802
• Other study ID #: PTG-300-08
• Status: Completed
• Phase: Phase 2
• Start date: February 2, 2021
• Est. completion date: March 15, 2023

Study information

• Verified date: March 2024
• Source: Protagonist Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 15, 2023
• Est. primary completion date: March 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Polycythemia
• Polycythemia Vera

Intervention

Drug:
• PTG-300
Hepcidin mimetic

Locations

Country	Name	City	State
Korea, Republic of	Gachon University Medical Center	Incheon
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Seoul St. Mary's Catholic University Hospital	Seoul
Malaysia	Hospital Ampang	Ampang	Selangor
Malaysia	Hospital Raja Permaisuki Bainun	Ipoh	Perak
Malaysia	Hospital Sultanah Aminah	Johor Bahru	Johor
Malaysia	Hospital Raja Perempuan Zainab	Kota Bharu	Kelantan
Malaysia	Hospital Umum Sarawak	Kuching	Sarawak

Sponsors (1)

Lead Sponsor	Collaborator
Protagonist Therapeutics, Inc.

Countries where clinical trial is conducted

Korea, Republic of,  Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate PTG-300's efficacy in subjects with PV and baseline elevated hematocrit.	Proportion of subjects with hematocrit <45%	Estimate the proportion of subject with a hematocrit less than 45% at Week 16
Secondary	Safety of PTG-300	Proportion of Subjects Treatment-Emergent Adverse Events	Week 52