What are clinical research studies?

Has your essential thrombocythemia (ET) therapy stopped working?

You may be eligible to join a Phase 3 clinical research study in the U.S. that evaluates the potential of a new, investigational ET therapy to reduce the number of platelets in the blood. 
Where are the clinical study sites in the U.S.?
(Rollover locations to view contact information)
MD Anderson Cancer Center
Principal Investigator: Dr Srdan Verstovsek
Study Coordinator: Nichole Ard
Site Phone: 713-745-3429
Site Email: nard@mdanderson.org
University of Texas Health Science Center at San Antonio
Principal Investigator: Dr Ruben Mesa
Study Coordinator: Epp Goodwin
Site Phone: 210-450-5798
Site Email: goodwine@uthscsa.edu
Weill Medical College of Cornell University
Principal Investigator: Dr Ghaith Abu-Zeinah
Study Coordinator: Niamh Savage
Site Phone: 212-746-0284
Site Email: nis2049@med.cornell.edu
Mount Sinai Medical Center
Principal Investigator: Dr John Mascarenhas
Study Coordinator: Lonette Sandy
Site Phone: 212-241-4546
Site Email: lonette.sandy@mssm.edu
Froedtert Hospital and the Medical College of Wisconsin
Principal Investigator: Dr Laura Michaelis
Study Coordinator: Paulette Jacobs
Site Phone: 414-805-4196
Site Email: pjacobs@mcw.edu
Washington University School of Medicine
Principal Investigator: Dr Stephen Oh
Study Coordinator: Karyn Gordon
Site Phone: 314-362-0156
Site Email: kdgordon@wustl.edu
Mayo Clinic - Scottsdale
Principal Investigator: Dr Jeanne Palmer
Study Coordinator: Crystal Anderson
Site Phone: 855-776-0015
Site Email: anderson.crystal2@mayo.edu
University of Michigan
Principal Investigator: Dr Kristen Pettit
Study Coordinator: Stephen Tryban
Site Phone: 734-615-0052
Site Email: stephtho@med.umich.edu
University of Utah
Principal Investigator: Dr Tsewang Tashi
Study Coordinator: Karen Pena
Site Phone: 801-213-5601
Site Email: karen.pena@hci.utah.edu
University of Kansas Cancer Center
Principal Investigator: Dr Abdulraheem Yacoub
Study Coordinator: Marc Morrison
Site Phone: 913-588-7585
Site Email: mmorrison3@kumc.edu
MD Anderson Cancer Center
Principal Investigator: Srdan Verstovsek, MD
Study Coordinator: Nichole Ard
Site Phone:
Site Email: nard@mdanderson.org
What is Essential Thrombocythemia?
Essential Thrombocythemia

Essential thrombocythemia (ET) is a condition characterized by an excessive increase of the number of platelets in your blood. Platelets cause blot clots and vascular complications. Some people with ET have no symptoms, while others develop many health problems due to additional platelets in the blood.

Symptoms can include the following:

ET can also cause more serious problems from increased risk of blood clots, including strokes and heart attacks, although these are rare events.
Controlling the number of platelets in the blood can help to reduce these
symptoms and health risks.

The P1101 ET Study

The P1101 ET study is for people with ET, who have tried other therapy options, like hydroxyurea, that are no longer effective at controlling their ET or that have such extreme side effects that people stop using them. The goal of this study is to compare the new study therapy, ropeginterferon alfa-2b (P1101), to the approved ET therapy, anagrelide.

The study therapy (P1101) is considered investigational because it has not been approved for public use and can only be used in clinical research studies like this P1101 ET study. The study therapy (P1101) is designed to reduce the number of platelets in the blood. It is given as an injection under the skin every 2 weeks.

Who can participate in the study?
You may qualify to participate in the study if you meet basic study requirements*:
What is the study therapy?
PharmaEssentia
Study Overview—What To Expect
Study participation will last about 14 months and is divided into 3 study periods:
Study Qualification

4 Weeks
You should have already completed the Study Qualification period to confirm that you qualify for the study.

Study Participation

52 Weeks

Study Follow-up

4 Weeks after last treatment visit

Post-Study Therapy
Where are the clinical study sites in the U.S.?
(Rollover locations to view contact information)
MD Anderson Cancer Center
Principal Investigator: Dr Srdan Verstovsek
Study Coordinator: Nichole Ard
Site Phone: 713-745-3429
Site Email: nard@mdanderson.org
University of Texas Health Science Center at San Antonio
Principal Investigator: Dr Ruben Mesa
Study Coordinator: Epp Goodwin
Site Phone: 210-450-5798
Site Email: goodwine@uthscsa.edu
Weill Medical College of Cornell University
Principal Investigator: Dr Ghaith Abu-Zeinah
Study Coordinator: Niamh Savage
Site Phone: 212-746-0284
Site Email: nis2049@med.cornell.edu
Mount Sinai Medical Center
Principal Investigator: Dr John Mascarenhas
Study Coordinator: Lonette Sandy
Site Phone: 212-241-4546
Site Email: lonette.sandy@mssm.edu
Froedtert Hospital and the Medical College of Wisconsin
Principal Investigator: Dr Laura Michaelis
Study Coordinator: Paulette Jacobs
Site Phone: 414-805-4196
Site Email: pjacobs@mcw.edu
Washington University School of Medicine
Principal Investigator: Dr Stephen Oh
Study Coordinator: Karyn Gordon
Site Phone: 314-362-0156
Site Email: kdgordon@wustl.edu
Mayo Clinic - Scottsdale
Principal Investigator: Dr Jeanne Palmer
Study Coordinator: Crystal Anderson
Site Phone: 855-776-0015
Site Email: anderson.crystal2@mayo.edu
University of Michigan
Principal Investigator: Dr Kristen Pettit
Study Coordinator: Stephen Tryban
Site Phone: 734-615-0052
Site Email: stephtho@med.umich.edu
University of Utah
Principal Investigator: Dr Tsewang Tashi
Study Coordinator: Karen Pena
Site Phone: 801-213-5601
Site Email: karen.pena@hci.utah.edu
University of Kansas Cancer Center
Principal Investigator: Dr Abdulraheem Yacoub
Study Coordinator: Marc Morrison
Site Phone: 913-588-7585
Site Email: mmorrison3@kumc.edu
MD Anderson Cancer Center
Principal Investigator: Srdan Verstovsek, MD
Study Coordinator: Nichole Ard
Site Phone:
Site Email: nard@mdanderson.org
Questions?

Ray Urbanski, MD, PhD
Head of Clinical Development and 

Medical Affairs
Ray_Urbanski@pharmaessentia-us.com
+1-973-873-8306
PharmaEssentia USA
35 Corporate Drive, Suite 325
Burlington, MA 01803

About PharmaEssentia

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