A Single-arm, Multicenter Study to Assess the Efficacy, Safety, and Tolerability of P1101 in Adults With ET

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
PharmaEssentia
Study ID
NCT05482971
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Essential Thrombocythemia

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

A Single-arm, Multicenter Study to Assess the Efficacy, Safety, and Tolerability of Ropeginterferon alfa-2b-njft (P1101) in Adult Patients with Essential Thrombocythemia

Key Dates

Start date
Sep 29, 2022
Status verified
Aug 2025
Primary completion
May 9, 2025
Completion
Mar 31, 2027

Study Design

Enrollment
91 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Ropeginterferon alfa-2b (P1101)
    Pre-filled Syringe, Q2W, SC injection

Primary Outcome Measure

To assess efficacy of ropeginterferon alfa-2b-njft (P1101) in adult USA/Canadian patients with ET [ Time Frame: 12 months ]

Locations (30)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35294-
City of Hope National Medical CenterDuarteCalifornia91010-
Marin Cancer CareGreenbraeCalifornia94904-
USC Norris Comprehensive Cancer CenterLos AngelesCalifornia90033-
Yale University School of Medicine - Yale Cancer CenterNew HavenConnecticut06510-
Georgetown University Medical CenterWashington D.C.District of Columbia20057-
The Winship Cancer Institute Emory UniversityAtlantaGeorgia30322-
Fort Wayne Medical Oncology and HematologyFort WayneIndiana46804-
Mercy Health - Paducah Medical Oncology and HematologyPaducahKentucky42003-
Tulane University Medical CenterNew OrleansLouisiana70112-
Greater Baltimore Medical CenterBaltimoreMaryland21204-
Dana-Farber Cancer InstituteBostonMassachusetts02215-
Massachusetts General HospitalBostonMassachusetts02114-
Washington University School of Medicine - Division of OncologySt LouisMissouri63110-
Cancer Care SpecialistsRenoNevada89511-
Astera HealthCareEast BrunswickNew Jersey08816-
John Theurer Cancer Center At Hackensack UMCHackensackNew Jersey07601-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
Weill Medical College of Cornell UniversityNew YorkNew York10021-
Stony Brook University Medical CenterStony BrookNew York11794-
Montefiore Medical CenterThe BronxNew York10467-
University of North Carolina (UNC) - Lineberger Comprehensive Cancer CenterChapel HillNorth Carolina27514-
Duke University Medical CenterDurhamNorth Carolina27710-
East Carolina UniversityGreenvilleNorth Carolina27858-
Regional Medical Oncology CenterWilsonNorth Carolina27893-
University of Tennessee Health Science CenterMemphisTennessee38103-
MD Anderson Cancer CenterHoustonTexas77030-
University of UtahSalt Lake CityUtah84132-
University of Virginia - Emily Couric Cancer CenterCharlottesvilleVirginia22903-
Fred Hutchinson Cancer Research CenterSeattleWashington98109-

Find similar trials in Birmingham, AL

By research site
University of Alabama at Birmingham· Birmingham, ALCity of Hope National Medical Center· Duarte, CAMarin Cancer Care· Greenbrae, CAUSC Norris Comprehensive Cancer Center· Los Angeles, CAYale University School of Medicine - Yale Cancer Center· New Haven, CTGeorgetown University Medical Center· Washington D.C., DC

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