Randomized Trial of Pegylated Interferon Alfa-2a Versus Hydroxyurea in Polycythemia Vera (PV) and Essential Thrombocythemia (ET)
Public ClinicalTrials.gov record NCT01259856. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Randomized Trial of Pegylated Interferon Alfa-2a Versus Hydroxyurea Therapy in the Treatment of High Risk Polycythemia Vera (PV) and High Risk Essential Thrombocythemia (ET)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This research is looking at two conditions, Essential Thrombocythemia (ET) and Polycythemia Vera (PV). ET causes people to produce too many blood cells called platelets and PV causes too many platelets and red blood cells to be made. Platelets are particles which circulate in the blood stream and normally prevent bleeding and bruising. Having too many platelets in the blood increases the risk of developing blood clots, which can result in life threatening events like heart attacks and strokes. When the number of red blood cells is increased in PV this will slow the speed of blood flow in the body and increases the risk of developing blood clots. The purpose of this study is to look at the effectiveness of giving participants who have been diagnosed with ET or PV one of two different study regimens over time. The study subject will be followed for their condition for about 5 years. The subject will be randomized into one of two study regimens, either Pegylated Interferon Alfa-2a (PEGASYS) or Aspirin and Hydroxyurea (also called Hydroxycarbamide). The subject must be newly diagnosed or already receiving treatment for either PV or ET. Each of the study drugs used in this study is already being used to treat subjects with ET or PV currently, but the investigators are unsure which study drug is better.
Study identification
- NCT ID
- NCT01259856
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 168 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 31, 2011
- Primary completion
- Jun 29, 2017
- Completion
- Jun 29, 2017
- Last update posted
- Apr 29, 2019
2011 – 2017
United States locations
- U.S. sites
- 16
- U.S. states
- 10
- U.S. cities
- 13
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Mayo Clinic | Scottsdale | Arizona | 85259 | — |
| USC Norris Comprehensive Cancer Center | Los Angeles | California | 90033 | — |
| The Palo Alto Clinic | Palo Alto | California | 94301 | — |
| Stanford University School of Medicine | Stanford | California | 94305 | — |
| Georgetown University Medical Center | Washington D.C. | District of Columbia | 20007 | — |
| Emory Hospital | Atlanta | Georgia | 30322 | — |
| John H. Stroger Hospital of Cook County | Chicago | Illinois | 60612 | — |
| University of Illinois at Chicago | Chicago | Illinois | 60612 | — |
| University of Kansas Cancer Center | Westwood | Kansas | 66205 | — |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | — |
| Memorial Sloan-Kettering Cancer Center | New York | New York | 10065 | — |
| Weill Cornell Medical College | New York | New York | 10065 | — |
| Duke University Medical Center | Durham | North Carolina | 27710 | — |
| Wake Forest University Baptist Medical Center | Winston-Salem | North Carolina | 27157 | — |
| Geisinger Cancer Center | Danville | Pennsylvania | 17822 | — |
| University of Utah | Salt Lake City | Utah | 84132 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 9 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01259856, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 29, 2019 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01259856 live on ClinicalTrials.gov.