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Interferon

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

Phase 3
Waitlist Available
Research Sponsored by PharmaEssentia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Documented resistance/intolerance to prior HU for ET, referencing modified ELN criteria (Barosi, et al, 2007), whereby at least one of the following criteria is met: Platelet count >600 x 10^9/L at ≥2 g/day (or ≥2.5 g/day if subject body weight >80 kg) or maximally tolerated dose if <2 g/day after at least 3 months of HU, or Platelet count >400 x 10^9/L and WBC count <2.5 x 10^9/L at any dose and any duration of HU, or Platelet count >400 x 10^9/L and hemoglobin (HGB) <10 g/dL at any dose and any duration of HU, or Presence of HU-related toxicities at any dose and any duration of therapy (e.g., leg ulcers, mucocutaneous manifestations, pneumonitis, or HU-related fever), or Platelet count >450 x 10^9/L at any dose and any duration of HU. The actual dose and duration of HU must be recorded on the eCRF. Moreover, if patient received one dose of HU, the reason why subject was judged to be HU resistance/intolerance must be recorded on the eCRF.
HGB ≥11 g/dL at screening for males and 10 g/dL at screening for females
Must not have
Known risk factors for QT-prolongation (e.g., congenital long QT, known history of acquired QT-prolongations). Medications that can prolong QTc and induce hypokalemia will not be allowed in the study
Any contraindications or hypersensitivity to IFN-α or ANA and their excipients
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3, 6, 9, and 12 months
Awards & highlights
All Individual Drugs Already Approved
Approved for 5 Other Conditions
Pivotal Trial
No Placebo-Only Group

Summary

This trial is testing a new drug, P1101, to see if it is more effective and has fewer side effects than the current standard drug, ANA, for treating people with essential thrombocythemia who have not responded well to hydroxyurea.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Possible side effects include reactions related to the immune system, such as flu-like symptoms from interferons, and cardiovascular issues like heart palpitations from Anagrelide. Each drug may also cause general discomforts like headaches, fatigue, nausea, or dizziness.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have had a bad reaction or no improvement with hydroxyurea for my blood condition.
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My hemoglobin level is at least 11 g/dL if I'm male, or 10 g/dL if I'm female.
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My liver is functioning well according to recent tests.
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I am resistant or intolerant to hydroxyurea for my essential thrombocythemia.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I don't have a history of long QT syndrome and am not on medications that can prolong QTc.
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I am not allergic to IFN-α, ANA, or their ingredients.
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I need someone legally authorized to make decisions for me.
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I have a history of myeloproliferative neoplasms.
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I have a history of autoimmune disease like thyroid issues or arthritis.
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I haven't had any cancer except for some skin cancers or very early leukemia in the last 5 years.
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I have a serious brain or nerve disease.
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I have had a major organ transplant.
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I have severe eye problems due to an infection, diabetes, or high blood pressure.
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I do not have any active infections with symptoms throughout my body, except for HBV or HCV.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3, 6, 9, and 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3, 6, 9, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Absence of hemorrhagic or thrombotic events
Improvement or non-progression in disease-related signs
Large symptoms improvement or maintain non-progression
+1 more
Secondary study objectives
Change of CALR, MPL, and JAK-2 allelic burden over time
Durable response
Duration of peripheral blood count remission response
+7 more
Other study objectives
Bone marrow histological remission

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

Find a Location

Who is running the clinical trial?

EPS InternationalUNKNOWN
Medpace, Inc.Industry Sponsor
96 Previous Clinical Trials
29,703 Total Patients Enrolled
PharmaEssentiaLead Sponsor
22 Previous Clinical Trials
2,583 Total Patients Enrolled

Media Library

Ropeginterferon alfa-2b (Interferon) Clinical Trial Eligibility Overview. Trial Name: NCT04285086 — Phase 3
Essential Thrombocythemia Research Study Groups: Ropeginterferon alfa-2b (P1101), Anagrelide
Essential Thrombocythemia Clinical Trial 2023: Ropeginterferon alfa-2b Highlights & Side Effects. Trial Name: NCT04285086 — Phase 3
Ropeginterferon alfa-2b (Interferon) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04285086 — Phase 3
~0 spots leftby Nov 2024
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