Trials / Completed
CompletedNCT04767802
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 (PACIFIC)
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 20 (actual)
- Sponsor
- Protagonist Therapeutics, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | PTG-300 | Hepcidin mimetic |
Timeline
- Start date
- 2021-02-02
- Primary completion
- 2023-03-15
- Completion
- 2023-03-15
- First posted
- 2021-02-23
- Last updated
- 2024-03-18
Locations
8 sites across 2 countries: Malaysia, South Korea
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04767802. Inclusion in this directory is not an endorsement.