Spots Global Cancer Trial Database for A Study to Assess Efficacy, Safety, and Tolerability of P1101 in Adult Patients With PV
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Trial Identification
Brief Title: A Study to Assess Efficacy, Safety, and Tolerability of P1101 in Adult Patients With PV
Official Title: A Phase IIIb, Randomized, Open-Label, Parallel Group, Multicenter Study to Assess Efficacy, Safety, and Tolerability of Two Dosing Regimens of Ropeginterferon Alfa-2b-njft (P1101) in Adult Patients With Polycythemia Vera (PV)
Study ID: NCT05481151
Conditions
Study Description
Brief Summary: A Study to Assess Efficacy, Safety, and Tolerability of P1101 in Adult Patients with PV
Detailed Description: Polycythemia vera (PV) is the most common type of chronic myeloproliferative neoplasm (MPN), with an annual reported incidence of up to 2.6/100,000. This is a long-term debilitating and life-threatening disease because it is associated with the risk of thrombosis, bleeding, and progression to myelofibrosis (MF) and secondary acute myeloid leukemia (sAML) Ropeginterferon alfa-2b-njft (P1101), which gained US marketing authorization in November 2021, is the only interferon alfa approved for the treatment of PV. This study aims to evaluate the efficacy, tolerability, and safety of ropeginterferon alfa-2b-njft (P1101) in US and Canadian PV patients, utilizing an optimized dosing regimen.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Baptist MD Anderson, Jacksonville, Florida, United States
Fort Wayne Medical Oncology and Hematology, Fort Wayne, Indiana, United States
University of Kansas Medical Center, Westwood, Kansas, United States
Mercy Health, Paducah, Kentucky, United States
Tulane University Medical Center, New Orleans, Louisiana, United States
American Oncology Partners of Maryland PA (Center for Cancer & Blood Disorders), Bethesda, Maryland, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
Astera HealthCare, East Brunswick, New Jersey, United States
Montefiore Medical Center, Bronx, New York, United States
Mount Sinai, New York, New York, United States
University of North Carolina Lineberger Comprehensive Cancer Center, Chapel Hill, North Carolina, United States
East Carolina University, Greenville, North Carolina, United States
Wake Forest Baptist Medical Center, High Point, North Carolina, United States
University of Tennessee Health Science Center, Memphis, Tennessee, United States
MD Anderson, Houston, Texas, United States
University of Utah, Salt Lake City, Utah, United States
University of Virginia - Emily Couric Cancer Center, Charlottesville, Virginia, United States
Tom Baker Cancer Centre, Calgary, Alberta, Canada
St. Paul's Hospital, Vancouver, British Columbia, Canada
Juravinski Cancer Center - Hamilton Health Sciences, Hamilton, Ontario, Canada
The Ottawa Hospital, Ottawa, Ontario, Canada
St. Michael's Hospital, Toronto, Ontario, Canada
Princess Margaret Hospital, Toronto, Ontario, Canada
Contact Details
Name: Ray Urbanski, MD, PhD
Affiliation: PharmaEssentia USA Corporation
Role: STUDY_DIRECTOR
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