Ropeginterferon Alfa-2b for Essential Thrombocythemia
(SURPASS ET Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests Ropeginterferon alfa-2b for individuals with essential thrombocythemia (ET), a condition that causes an excess of platelets in the blood, potentially leading to clotting issues. The trial aims to evaluate the effectiveness and safety of this treatment compared to Anagrelide. It targets those who have tried hydroxyurea but experienced poor responses or intolerance. This trial may suit individuals with ET who have faced issues like blood clots or bleeding and have not found success with previous treatments. As a Phase 3 trial, this treatment represents the final step before FDA approval, offering hope for those seeking new, effective options.
Will I have to stop taking my current medications?
The trial requires a washout period (time without taking certain medications) of at least 7 days for hydroxyurea (HU) and 14 days for interferon before starting the study. Other medications that can prolong QTc and induce low potassium levels are not allowed during the study.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that ropeginterferon alfa-2b is generally well-tolerated by people with essential thrombocythemia. Studies have found no serious side effects directly related to the medication. Most participants managed the side effects, indicating that the treatment is relatively safe for humans.
In comparison, another study found that ropeginterferon alfa-2b had better safety outcomes than anagrelide, another treatment option for this condition. These findings, based on research, can help provide some peace of mind about the treatment's safety.12345Why do researchers think this study treatment might be promising for essential thrombocythemia?
Ropeginterferon alfa-2b is unique because it offers a new approach for managing essential thrombocythemia by using a long-acting interferon. Unlike standard treatments like hydroxyurea and anagrelide, which primarily target platelet production, ropeginterferon alfa-2b works by modulating the immune system to reduce platelet levels. Additionally, it is administered via a subcutaneous injection every two weeks, potentially improving patient compliance compared to daily oral medications. Researchers are excited about its potential for fewer side effects and long-term benefits in controlling the disease.
What evidence suggests that this trial's treatments could be effective for essential thrombocythemia?
Studies have shown that ropeginterferon alfa-2b, a treatment tested in this trial, effectively treats essential thrombocythemia (ET). One study found that 42.9% of patients experienced strong, lasting improvements at both 9 and 12 months. Research also indicates that ropeginterferon alfa-2b outperforms anagrelide, the other treatment option in this trial, particularly for those who did not respond well to previous treatments. This treatment has proven both effective and safe, making it a promising option for people with ET.12367
Who Is on the Research Team?
Toshiaki Sato, MD/PhD
Principal Investigator
PharmaEssentia Japan K.K.
Craig Zimmerman, PhD
Principal Investigator
PharmaEssentia USA Corp.
Are You a Good Fit for This Trial?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either P1101 or Anagrelide for 12 months as second-line therapy
Follow-up
Participants are monitored for safety and effectiveness after treatment
Open-label extension (optional)
Participants may opt into continuation of P1101 treatment long-term
What Are the Treatments Tested in This Trial?
Interventions
- Anagrelide
- Ropeginterferon alfa-2b
Trial Overview
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.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Pre-filled Syringe, Q2W, SC injection
Capsules, Daily, p.o.
Find a Clinic Near You
Who Is Running the Clinical Trial?
PharmaEssentia
Lead Sponsor
EPS International
Collaborator
Medpace, Inc.
Industry Sponsor
Dr. August J. Troendle
Medpace, Inc.
Chief Executive Officer since 1992
MD from the University of Maryland, School of Medicine; MBA from Boston University
Dr. Reinilde Heyrman
Medpace, Inc.
Chief Medical Officer since 2017
MD
Brightech International
Collaborator
Citations
1.
targetedonc.com
targetedonc.com/view/ropeginterferon-alfa-2b-succeeds-in-phase-3-essential-thrombocythemia-trialRopeginterferon Alfa-2b Succeeds in Phase 3 Essential ...
In the intent-to-treat (ITT) population, 42.9% (39/91) of patients treated with ropeginterferon alfa-2b had durable responses at 9 and 12 months ...
Topline results of the phase 3 SURPASS-ET trial.
Conclusions: Ropeg showed superior efficacy and safety compared to anagrelide as second-line therapy for ET. It represents a potential new ...
Ropeginterferon Alfa-2b Generates Superior Efficacy vs ...
Ropeginterferon alfa-2b showed superior efficacy over anagrelide in achieving durable responses in high-risk essential thrombocythemia patients.
A multicenter study to assess efficacy, safety, and tolerability of ...
A multicenter study to assess efficacy, safety, and tolerability of ropeginterferon alfa-2b-njft in patients with essential thrombocythemia in the US and ...
Real-World Evidence on Outcomes and Safety of ...
Ropeginterferon alfa-2b-njft (ropegIFN) has demonstrated superior efficacy over hydroxyurea in polycythemia vera (PV); however, real-world ...
6.
dailynews.ascopubs.org
dailynews.ascopubs.org/do/ropeginterferon-alfa-2b-demonstrates-superior-efficacy-and-safety-anagrelide-secondRopeginterferon Alfa-2b Demonstrates Superior Efficacy ...
In the phase 3 SURPASS-ET trial, ropeg showed superior efficacy and safety compared with anagrelide as second-line therapy for essential thrombocythemia.
7.
ashpublications.org
ashpublications.org/ashclinicalnews/news/8644/Ropeg-May-Provide-New-Treatment-Option-forRopeg May Provide New Treatment Option for Essential ...
Dr. Gill noted that 27.8% of patients in the ropeg arm achieved a partial molecular response, and 2.8% achieved a complete response, while none ...
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