PTG-300 in Patients With Polycythemia Vera & Elevated Hematocrit

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.

See also
Status	Clinical Trial	Phase
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Completed	`NCT02912884` - Treatment of Polycythaemia Vera and Essential Thrombocythaemia: Influence on the Clot Structure
Recruiting	`NCT02897297` - Myeloproliferative Neoplastic Diseases Observatory From Brest
Completed	`NCT01949805` - Pegylated Interferon Alpha-2b Versus Hydroxyurea in Polycythemia Vera	Phase 3
Completed	`NCT00666549` - Research Tissue Bank
Completed	`NCT00241241` - Efficacy and Safety of Pegylated Interferon Alfa in Polycythemia Vera	Phase 2
Completed	`NCT00052520` - Biological Therapy in Treating Patients With Advanced Myelodysplastic Syndrome, Acute or Chronic Myeloid Leukemia, or Acute Lymphoblastic Leukemia Who Are Undergoing Stem Cell Transplantation	Phase 1/Phase 2
Active, not recruiting	`NCT05485948` - A Study to Access Efficacy and Safety of P1101 in Chinese PV Patients Who Are Intolerant or Resistance to HU	Phase 2
Completed	`NCT01588015` - Vaccine Therapy in Preventing Cytomegalovirus Infection in Patients With Hematological Malignancies Undergoing Donor Stem Cell Transplant	Phase 1
Completed	`NCT01243944` - Study of Efficacy and Safety in Polycythemia Vera Subjects Who Are Resistant to or Intolerant of Hydroxyurea: JAK Inhibitor INC424 (INCB018424) Tablets Versus Best Available Care: (The RESPONSE Trial)	Phase 3
Recruiting	`NCT05481151` - A Study to Assess Efficacy, Safety, and Tolerability of P1101 in Adult Patients With PV	Phase 3
Recruiting	`NCT05031897` - Reduced-Intensity Conditioning for the Prevention of Treatment-Related Mortality in Patients Who Undergo a Hematopoietic Stem Cell Transplant	Phase 2
Recruiting	`NCT04116502` - MITHRIDATE: Ruxolitinib Versus Hydroxycarbamide or Interferon as First Line Therapy in High Risk Polycythemia Vera	Phase 3
Completed	`NCT01901432` - A Two-part Study to Assess the Safety and Preliminary Efficacy of Givinostat in Patients With Polycythemia Vera	Phase 1/Phase 2
Recruiting	`NCT04262141` - IMG-7289 in Patients With Essential Thrombocythemia (ET) or Polycythemia Vera (PV)	Phase 2
Not yet recruiting	`NCT05566535` - Changes in QoL and Symptoms in Patients With Polycythemia Vera Receiving Ruxo in a Routine Clinical Practice
Active, not recruiting	`NCT04057040` - Hepcidin Mimetic in Patients With Polycythemia Vera (REVIVE)	Phase 2
Completed	`NCT03907436` - The NUTRIENT Trial (NUTRitional Intervention Among myEloproliferative Neoplasms): Feasibility Phase	N/A
Completed	`NCT01981850` - A Phase 2 Study of RO7490677 In Participants With Myelofibrosis	Phase 2

NCT number	NCT04767802
Study type	Interventional
Source	Protagonist Therapeutics, Inc.
Contact
Status	Completed
Phase	Phase 2
Start date	February 2, 2021
Completion date	March 15, 2023

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms