PTG-300 in Patients With Polycythemia Vera and Elevated Hematocrit

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

Sponsors

Lead Sponsor: Protagonist Therapeutics, Inc.

Source Protagonist Therapeutics, Inc.
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.

Overall Status Active, not recruiting
Start Date 2021-02-02
Completion Date 2023-04-30
Primary Completion Date 2022-10-30
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
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
Secondary Outcome
Measure Time Frame
Safety of PTG-300 Week 52
Enrollment 20
Condition
Intervention

Intervention Type: Drug

Intervention Name: PTG-300

Description: Hepcidin mimetic

Arm Group Label: PTG-300

Eligibility

Criteria:

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.

Gender:

All

Minimum Age:

18 Years

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Contact

Last Name: Study Director

Phone: 1-888-899-1543

Email: [email protected]

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

Korea, Republic of

Malaysia

Verification Date

2021-02-01

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: PTG-300

Type: Experimental

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

Patient Data No
Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

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