Ropeginterferon Alfa-2b for Essential Thrombocythemia
(SURPASS ET Trial)

Recruiting in Palo Alto (17 mi)

+76 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: PharmaEssentia

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

Adults with high-risk Essential Thrombocythemia who have not responded well to Hydroxyurea treatment. They must be Interferon-naïve or negative for anti-P1101 antibodies, meet specific blood count criteria, and have proper liver and kidney function. Participants need to agree to birth control measures and cannot be pregnant or breastfeeding.

Inclusion Criteria

I have taken hydroxyurea for essential thrombocythemia and stopped at least 14 days before joining.

Written informed consent obtained from the subject and ability for the subject to comply with the requirements of the study

I have had a bad reaction or no improvement with hydroxyurea for my blood condition.

+12 more

Exclusion Criteria

I don't have a history of long QT syndrome and am not on medications that can prolong QTc.

History or presence of clinically relevant depression, or previous suicide attempts or at any risk of suicide at screening, in the judgement of the Investigator

I am not allergic to IFN-α, ANA, or their ingredients.

+15 more

Participant Groups

The trial is testing Ropeginterferon Alfa-2b against Anagrelide in patients resistant or intolerant to Hydroxyurea as a second-line therapy for Essential Thrombocythemia. It's an open-label study where participants are randomly assigned one of the two drugs for comparison over 12 months.

2Treatment groups

Experimental Treatment

Active Control

Group I: Ropeginterferon alfa-2b (P1101)Experimental Treatment1 Intervention

Pre-filled Syringe, Q2W, SC injection

Group II: AnagrelideActive Control2 Interventions

Capsules, Daily, p.o.