A Study to Assess Efficacy, Safety, and Tolerability of P1101 in Adult Patients With PV

Part of paid clinical trials in Jacksonville, Florida.

Sponsor
PharmaEssentia
Study ID
NCT05481151
Phase
PHASE3
Status
Active Not Recruiting

Conditions

  • Polycythemia Vera

Eligibility Criteria

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

Interventions

Study Details

A Study to Assess Efficacy, Safety, and Tolerability of P1101 in Adult Patients with PV

Key Dates

Start date
Oct 26, 2022
Status verified
Aug 2025
Primary completion
Jun 30, 2025
Completion
Jul 31, 2027

Study Design

Enrollment
111 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: P1101 250-350-500mcg
    Pre-filled Syringe, Q2W starting at 250-350-500, SC injection
  • Active Comparator: Ropeginterferon alfa-2b-njft
    Pre-filled Syringe, Q2W starting at 100 up to 500 (50mcg increases), SC injection

Primary Outcome Measure

Compare efficacy, safety, and tolerability of P1101 utilizing 250-350-500 mcg compared to the current labeled dosing through assessing the proportion of subjects that are in a complete hematologic response at Week 24. [ Time Frame: 24 weeks ]

Locations (17)

FacilityCityStateZIPSite coordinators
Baptist MD AndersonJacksonvilleFlorida32207-
Fort Wayne Medical Oncology and HematologyFort WayneIndiana46804-
University of Kansas Medical CenterWestwoodKansas66205-
Mercy HealthPaducahKentucky42003-
Tulane University Medical CenterNew OrleansLouisiana70112-
American Oncology Partners of Maryland PA (Center for Cancer & Blood Disorders)BethesdaMaryland20817-
Washington University School of MedicineSt LouisMissouri63110-
Astera HealthCareEast BrunswickNew Jersey08816-
Mount SinaiNew YorkNew York10029-
Montefiore Medical CenterThe BronxNew York10467-
University of North Carolina Lineberger Comprehensive Cancer CenterChapel HillNorth Carolina27599-
East Carolina UniversityGreenvilleNorth Carolina27834-
Wake Forest Baptist Medical CenterHigh PointNorth Carolina27265-
University of Tennessee Health Science CenterMemphisTennessee38103-
MD AndersonHoustonTexas77030-
University of UtahSalt Lake CityUtah841312-
University of Virginia - Emily Couric Cancer CenterCharlottesvilleVirginia22903-

Find similar trials in Jacksonville, FL

By research site
Baptist MD Anderson· Jacksonville, FLFort Wayne Medical Oncology and Hematology· Fort Wayne, INUniversity of Kansas Medical Center· Westwood, KSMercy Health· Paducah, KYTulane University Medical Center· New Orleans, LAAmerican Oncology Partners of Maryland PA (Center for Cancer & Blood Disorders)· Bethesda, MD

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