Ropeginterferon Alfa-2b (P1101) vs. Anagrelide in Essential Thrombocythemia Patients With Hydroxyurea Resistance or Intolerance

Part of paid clinical trials in St Louis, Missouri.

Sponsor
PharmaEssentia
Study ID
NCT04285086
Phase
PHASE3
Status
Active Not Recruiting

Conditions

  • Essential Thrombocythemia

Eligibility Criteria

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

Interventions

  • Ropeginterferon alfa-2b — BIOLOGICAL
    Ropeginterferon alfa-2b (P1101) dosage: from 250 mcg to 500 mcg
  • Anagrelide — DRUG
    Anagrelide dosage: 0.5 mg per capsule, according to label and physician's judgement

Study Details

This is a Phase 3 open-label, multicenter, randomized, active-controlled study designed to compare the efficacy and safety and tolerability of P1101 compared with ANA after 12 months of treatment as second-line therapy for subjects with ET who have had a suboptimal or failed response to HU.

Key Dates

Start date
Aug 25, 2020
Status verified
Aug 2025
Primary completion
Nov 12, 2024
Completion
Aug 31, 2029

Study Design

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

Arms

  • Experimental: Ropeginterferon alfa-2b (P1101)
    Pre-filled Syringe, Q2W, SC injection
  • Active Comparator: Anagrelide
    Capsules, Daily, p.o.

Primary Outcome Measure

Peripheral blood count remission [ Time Frame: month 9 and month 12 ]

Locations (3)

FacilityCityStateZIPSite coordinators
Washington University School of Medicine - Division of OncologySt LouisMissouri63110-
MD Anderson Cancer CenterHoustonTexas77030-
University of UtahSalt Lake CityUtah84112-

Find similar trials in St Louis, MO

By research site
Washington University School of Medicine - Division of Oncology· St Louis, MOMD Anderson Cancer Center· Houston, TXUniversity of Utah· Salt Lake City, UT

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