Hepcidin Mimetic for Polycythemia Vera

Recruiting in Palo Alto (17 mi)

+16 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Protagonist Therapeutics, Inc.

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?This trial tests PTG-300, a new medication, in patients with polycythemia vera who need regular blood removal. PTG-300 aims to keep red blood cell levels in check, reducing the need for frequent blood removal.

Eligibility Criteria

Adults diagnosed with polycythemia vera, who've had regular phlebotomies for at least 28 weeks and are either on a stable or decreasing dose of cytoreductive therapy (like hydroxyurea, interferon, or ruxolitinib) for over 24 weeks. Those not on such therapies must have stopped them for at least 24 weeks prior.

Inclusion Criteria

You must meet ALL of the following inclusion criteria to be enrolled.

Records of all phlebotomies performed for at least 28 weeks (preferably up to 52 weeks) before dosing are available.

I've been on a stable or decreasing dose of specific blood cancer treatments for at least 8 weeks.

+13 more

Exclusion Criteria

I have not had any active or chronic bleeding in the last 4 weeks.

I haven't had surgery under general anesthesia in the last month and don't plan any during the study.

I have been diagnosed with myelofibrosis following polycythemia vera.

+1 more

Participant Groups

The trial is testing PTG-300, a hepcidin mimetic against a placebo in patients requiring frequent blood withdrawals due to polycythemia vera. It includes an initial phase where everyone gets PTG-300 to find the best dose followed by a blind test where neither doctors nor patients know who's getting what.

2Treatment groups

Experimental Treatment

Group I: Dose finding PTG-300 (Part 1); Placebo (Part 2); Open label extension PTG-300 (Part 3)Experimental Treatment2 Interventions

Group II: Dose finding PTG-300 (Part 1); PTG-300 (Part 2); Open label extension PTG-300 (Part 3)Experimental Treatment1 Intervention