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NCT04285086 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study of Essential Thrombocythemia, sponsored by PharmaEssentia.

Active
Registry status
Phase 3
Development phase
174
Enrollment target
20
Study locations

NCT04285086 is a Phase 3 study of Essential Thrombocythemia that is active but no longer recruiting, run by PharmaEssentia. The registered enrollment target is 174 participants, above the 77-participant average among 16 other Essential Thrombocythemia trials with a reported enrollment target (126% higher). The trial reports 20 study locations across 17 states.

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The verdict

NCT04285086, a Phase 3 study of Essential Thrombocythemia, is active but no longer recruiting, sponsored by PharmaEssentia.

ACTIVE NOT RECRUITING
Registry status
Phase 3
Development phase
174 participants
Enrollment target
20
Study locations

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 Studied

Interventions

  • DRUG Anagrelide
  • BIOLOGICAL Ropeginterferon alfa-2b

Study Locations (20)

Beijing Municipality

  • Peking Union Medical College Hospital - Beijing
  • Peking University People's Hospital - Beijing

Hubei

  • Union Hospital Tongji Medical College Huazhong University of Science and Technolog - Wuhan
  • Zhongnan Hospital of Wuhan University - Wuhan

Tianjin Municipality

  • The Second Hospital of Tianjin Medical University - Tianjin
  • Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences - Tianjin

Missouri

  • Washington University School of Medicine - Division of Oncology - St Louis

Texas

  • MD Anderson Cancer Center - Houston

Utah

  • University of Utah - Salt Lake City

British Columbia

  • St. Paul's Hospital - Vancouver

Ontario

  • Princess Margaret Hospital - Toronto

Trial Details

FieldValue
Enrollment Target 174 participants
Start Date 2020-08-25
Est. Completion 2029-08-31
Phase Phase 3

Sponsor

PharmaEssentia

3 total trials

What the Registry Record Tells You About NCT04285086

The ClinicalTrials.gov registry entry for NCT04285086 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 174 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 77-participant average among 16 other Essential Thrombocythemia trials with a reported enrollment target (126% higher). The listed sponsor is PharmaEssentia, which has 3 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Essential Thrombocythemia appearing as the primary indexed condition, and to 2 interventions - of which Anagrelide is the first listed.

NCT04285086 reports 20 study locations spanning 17 distinct geographic areas - top geographies include Beijing Municipality, Hubei, Tianjin Municipality.

Frequently Asked Questions

What is clinical trial NCT04285086 about?

NCT04285086 is a clinical study titled "Ropeginterferon Alfa-2b (P1101) vs. Anagrelide in Essential Thrombocythemia Patients With Hydroxyurea Resistance or Intolerance". 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.

What is the current status of trial NCT04285086?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 174 participants. The study started on 2020-08-25. Estimated completion is 2029-08-31.

What conditions does trial NCT04285086 study?

This clinical trial studies the following conditions: Essential Thrombocythemia.

What interventions are being tested in trial NCT04285086?

The interventions under investigation include: Anagrelide (DRUG), Ropeginterferon alfa-2b (BIOLOGICAL).

Who is sponsoring clinical trial NCT04285086?

This trial is sponsored by PharmaEssentia, which has 3 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04285086 being conducted?

This trial has 20 study locations across Missouri, Texas, Utah, British Columbia, Ontario. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.