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

NCT04285086 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 174

Last updated 2025-08-13

No results posted yet for this study

Summary

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.

Conditions

  • Essential Thrombocythemia

Interventions

BIOLOGICAL

Ropeginterferon alfa-2b

Ropeginterferon alfa-2b (P1101) dosage: from 250 mcg to 500 mcg

DRUG

Anagrelide

Anagrelide dosage: 0.5 mg per capsule, according to label and physician's judgement

Sponsors & Collaborators

  • PharmaEssentia

    lead INDUSTRY

Principal Investigators

  • Toshiaki Sato, MD/PhD · PharmaEssentia Japan K.K.

  • Craig Zimmerman, PhD · PharmaEssentia USA Corp.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-25
Primary Completion
2024-11-12
Completion
2029-08-31
FDA Drug
Yes

Countries

  • United States
  • Canada
  • China
  • Hong Kong
  • Japan
  • Singapore
  • South Korea
  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04285086 on ClinicalTrials.gov