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NCT05482971 · ClinicalTrials.gov registry record · Phase 2
A Single-arm, Multicenter Study to Assess the Efficacy, Safety, and Tolerability of P1101 in Adults With ET
A Phase 2 study of Essential Thrombocythemia, sponsored by PharmaEssentia.
- Active
- Registry status
- Phase 2
- Development phase
- 91
- Enrollment target
- 20
- Study locations
NCT05482971: Active Phase 2 study of Essential Thrombocythemia, sponsored by PharmaEssentia.
NCT05482971 is a Phase 2 study of Essential Thrombocythemia that is active but no longer recruiting, run by PharmaEssentia. The registered enrollment target is 91 participants, above the 82-participant average among 16 other Essential Thrombocythemia trials with a reported enrollment target (11% higher). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05482971, a Phase 2 study of Essential Thrombocythemia, is active but no longer recruiting, sponsored by PharmaEssentia.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 91 participants
- Enrollment target
- 20
- Study locations
Study Summary
A Single-arm, Multicenter Study to Assess the Efficacy, Safety, and Tolerability of Ropeginterferon alfa-2b-njft (P1101) in Adult Patients with Essential Thrombocythemia
Primary Outcome
Efficacy will be based on peripheral blood count remission as defined by hematocrit (HCT) \<45%, white blood cell (WBC) count ≤10 × 109/L, and platelets (PLT) ≤ 400 × 109/L in at least 80% of bi-weekly measurements for a consecutive 32-wek period during the 52-week core study treatment period.
Conditions Studied
Interventions
- DRUG Ropeginterferon alfa-2b-njft (P1101)
Study Locations (20)
California
- City of Hope National Medical Center - Duarte
- Marin Cancer Care - Greenbrae
- USC Norris Comprehensive Cancer Center - Los Angeles
New York
- Weill Medical College of Cornell University - New York
- Memorial Sloan Kettering Cancer Center - New York
- Stony Brook University Medical Center - Stony Brook
Massachusetts
- Massachusetts General Hospital - Boston
- Dana-Farber Cancer Institute - Boston
New Jersey
- Astera HealthCare - East Brunswick
- John Theurer Cancer Center At Hackensack UMC - Hackensack
Alabama
- University of Alabama at Birmingham - Birmingham
Connecticut
- Yale University School of Medicine - Yale Cancer Center - New Haven
District of Columbia
- Georgetown University Medical Center - Washington D.C.
Georgia
- The Winship Cancer Institute Emory University - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 91 participants |
| Start Date | 2022-09-29 |
| Est. Completion | 2027-03-31 |
| Phase | Phase 2 |
What the registry record for NCT05482971 still lists
NCT05482971 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 91 participants, a relatively small participant target, above the 82-participant average among 16 other Essential Thrombocythemia trials with a reported enrollment target (11% higher).
The record links to 1 condition, with Essential Thrombocythemia appearing as the primary indexed condition, and to 1 intervention - of which Ropeginterferon alfa-2b-njft (P1101) is the first listed.
NCT05482971 names 20 study sites across 14 states, led by California, New York, Massachusetts.
Frequently Asked Questions
What is clinical trial NCT05482971 about?
NCT05482971 is a clinical study titled "A Single-arm, Multicenter Study to Assess the Efficacy, Safety, and Tolerability of P1101 in Adults With ET". A Single-arm, Multicenter Study to Assess the Efficacy, Safety, and Tolerability of Ropeginterferon alfa-2b-njft (P1101) in Adult Patients with Essential Thrombocythemia
What is the current status of trial NCT05482971?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 91 participants. The study started on 2022-09-29. Estimated completion is 2027-03-31.
What conditions does trial NCT05482971 study?
This clinical trial studies the following conditions: Essential Thrombocythemia.
What interventions are being tested in trial NCT05482971?
The interventions under investigation include: Ropeginterferon alfa-2b-njft (P1101) (DRUG).
Who is sponsoring clinical trial NCT05482971?
This trial is sponsored by PharmaEssentia, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05482971 being conducted?
This trial has 20 study locations across Alabama, California, Connecticut, District of Columbia, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05482971's enrollment target sits among peer trials
91 5th of 16 higher than 12 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.
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