Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Active Phase 3 study of Essential Thrombocythemia, sponsored by PharmaEssentia.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
platelets ≤400 x 10\^9/L AND white blood cells (WBC) \<9.5 x 10\^9/L
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 |
What the registry record for NCT04285086 still lists
NCT04285086 is an interventional study that assigns participants to a tested intervention. The registered 174 participants enrollment target is mid-sized for trials with a published cap, above the 77-participant average among 16 other Essential Thrombocythemia trials with a reported enrollment target (126% higher).
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 names 20 study sites across 17 states, led by 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.
Learn More About Clinical Trials
Similar trials for Essential Thrombocythemia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04285086's enrollment target sits among peer trials
174 3rd of 16 higher than 14 of 16 other Essential Thrombocythemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Essential Thrombocythemia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Bomedemstat vs Hydroxyurea for Essential Thrombocythemia (MK-3543-007)
RECRUITING · Phase 3
-
A Study of Bomedemstat (IMG-7289/MK-3543) Compared to Best Available Therapy (BAT) in Participants With Essential Thrombocythemia and an Inadequate Response or Intolerance of Hydroxyurea (MK-3543-006)
RECRUITING · Phase 3
-
A Randomized Study of ASTX727 With or Without Iadademstat in Advanced Myeloproliferative Neoplasms (MPNs)
RECRUITING · Phase 2
-
Ruxolitinib in Thrombocythemia and Polycythemia Vera
RECRUITING · Phase 2
-
Mutant CALR-peptide Based Vaccine in Patients With Mutated CALR Myeloproliferative Neoplasm
RECRUITING · Phase 1
-
Two Step Haplo With Radiation Conditioning
RECRUITING · Phase 2
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01000259 · 174 participants
Study of Tumor Tissue Samples From Patients Who Have Undergone Surgery for Advanced Stage III or Stage IV Ovarian Epithelial Cancer
- NCT04729114 · 174 participants · Phase 1
A Safety and Dose-finding Study of PRL-02 Depot in Men With Advanced Prostate Cancer
- NCT04884035 · 174 participants · Phase 1
Study of Safety and Efficacy of Iberdomide (CC-220) and CC-99282 Combined With R-CHOP to Treat Lymphoma
- NCT05075980 · 174 participants · Phase 2
Intensity Modulated Proton or X-Ray Therapy After Surgery for Treatment of Head and Neck Cancer, the HEADLIGHT Study
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI