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Ropeginterferon Alfa-2b (P1101) vs. Anagrelide in Essential Thrombocythemia Patients With Hydroxyurea Resistance or Intolerance
NCT04285086 · View on ClinicalTrials.gov ↗
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
| Field | Value |
|---|---|
| Enrollment Target | 174 participants |
| Start Date | 2020-08-25 |
| Est. Completion | 2029-08-31 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04285086
The ClinicalTrials.gov registry entry for NCT04285086 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 174 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is PharmaEssentia, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04285086 reports 20 study locations spanning 17 distinct geographic areas — top geographies include Beijing Municipality, Hubei, Tianjin Municipality. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04285086?
The interventions under investigation include: Anagrelide (DRUG), Ropeginterferon alfa-2b (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04285086?
This trial is sponsored by PharmaEssentia, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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