A Single-arm, Multicenter Study to Assess the Efficacy, Safety, and Tolerability of Ropeginterferon alfa-2b-njft (P1101) in Adult Patients with Essential Thrombocythemia

UVA Tracking #
HSR230024
Principal Investigator
Firas El Chaer
Contact
Contact Phone
Official Trial Title
A Single-arm, Multicenter Study to Assess the Efficacy, Safety, and Tolerability of
Ropeginterferon alfa-2b-njft (P1101) in Adult Patients with Essential
Thrombocythemia
Study Description

The University of Virginia is conducting a clinical research study for adults ages 18 and over who have essential thrombocythemia and need to start with therapy to reduce their blood count or whose current therapy is not sufficiently controlling their disease. The purpose of the study is to learn if the study drug, P1101 (Ropeginterferon alfa-2b-njft) can normalize blood counts. The safety of P1101 will also be studied. P1101 is an FDA approved dug, but it has not been FDA approved to treat essential thrombocythemia. If you choose to take part in the study, you will receive the study drug, P1101, every two weeks either in the clinic or at home.

You are expected to be in this research study for about 15 months. If you continue to benefit from P1101, you may have the opportunity to enter into the long term extension period. You will receive the study drug via an injection under the skin.

Study-related procedures that are being done beyond your standard of care will be provided at no cost to you or your insurance.

Additional information can be found here: https://clinicaltrials.gov/ct2/show/NCT05482971

uvacancertrials@hscmail.mcc.virginia.edu

The study team may arrange for your hotel, or you may be reimbursed by check up to $175 per night for a hotel. You may also receive up to $.54 cents per mile.

Compensation

No Compensation