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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3, 6, 9, and 12 months
Awards & highlights
SURPASS ET Trial 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.Check my eligibility
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.See study design
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.
SURPASS ET Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have had a bad reaction or no improvement with hydroxyurea for my blood condition.
Select...
My hemoglobin level is at least 11 g/dL if I'm male, or 10 g/dL if I'm female.
Select...
My liver is functioning well according to recent tests.
Select...
I am resistant or intolerant to hydroxyurea for my essential thrombocythemia.
SURPASS ET Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3, 6, 9, and 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3, 6, 9, and 12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Absence of hemorrhagic or thrombotic events
Improvement or non-progression in disease-related signs
Large symptoms improvement or maintain non-progression
+1 moreSecondary outcome measures
Change of CALR, MPL, and JAK-2 allelic burden over time
Durable response
Duration of peripheral blood count remission response
+7 moreOther outcome measures
Bone marrow histological remission
Side effects data
From 2015 Phase 4 trial • 150 Patients • NCT0020264425%
Headache
24%
Palpitations
12%
Hypertension
8%
Diarrhoea
8%
Arthralgia
7%
Vertigo
7%
Asthenia
5%
Epistaxis
5%
Anaemia
5%
Chest pain
5%
Upper respiratory tract infection
5%
Urinary tract infection
4%
Ischaemic stroke
3%
Nasopharyngitis
3%
Pharyngitis
1%
Cerebral infarction
1%
Neurological decompensation
1%
Vasculitis cerebral
1%
Left ventricular failure
1%
Sepsis
1%
Aphasia
1%
Bladder cancer
1%
Respiratory distress
1%
Adenoid cystic carcinoma
1%
Type 2 diabetes mellitus
1%
Pulmonary embolism
1%
Ovarian cyst
1%
Crohn's disease
1%
Tachycardia
1%
Laryngitis
1%
Upper gastrointestinal haemorrhage
1%
Sudden death
1%
Ear infection
1%
Leukopenia
1%
Hypertensive crisis
1%
Peripheral artery thrombosis
1%
Iron deficiency anaemia
1%
Angina unstable
1%
Traumatic haematoma
1%
Hyperglycaemia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Anagrelide
Hydroxyurea
SURPASS ET 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
94 Previous Clinical Trials
29,441 Total Patients Enrolled
PharmaEssentiaLead Sponsor
20 Previous Clinical Trials
1,238 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I don't have a history of long QT syndrome and am not on medications that can prolong QTc.I have taken hydroxyurea for essential thrombocythemia and stopped at least 14 days before joining.I have had a bad reaction or no improvement with hydroxyurea for my blood condition.I am not allergic to IFN-α, ANA, or their ingredients.I need someone legally authorized to make decisions for me.I have a history of myeloproliferative neoplasms.I am over 60 with a positive JAK2V617 test or have had blood clots or bleeding due to my condition.I have a history of autoimmune disease like thyroid issues or arthritis.I haven't had any cancer except for some skin cancers or very early leukemia in the last 5 years.My hemoglobin level is at least 11 g/dL if I'm male, or 10 g/dL if I'm female.I have a serious brain or nerve disease.My liver is functioning well according to recent tests.I have never had interferon treatment or tested negative for anti-P1101 antibodies.I am intolerant or resistant to ANA treatment.I have had a major organ transplant.I am resistant or intolerant to hydroxyurea for my essential thrombocythemia.I have severe eye problems due to an infection, diabetes, or high blood pressure.I do not have any active infections with symptoms throughout my body, except for HBV or HCV.I have never had interferon treatment or tested negative for anti-P1101 antibodies.I agree to use birth control during and up to 28 days after the study, and I will not breastfeed if participating.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Ropeginterferon alfa-2b (P1101)
- Group 2: Anagrelide
Awards:
This trial has 4 awards, including:- 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.
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the regulatory agency's stance on Ropeginterferon alfa-2b?
"There is some efficacy data and multiple rounds of safety data available from Phase 3 trials, so Ropeginterferon alfa-2b was given a score of 3 for safety."
Answered by AI
What goals does this research hope to realize?
"The primary goal of this study, to be evaluated at 9 and 12 months, is large symptom improvement or maintaining lack of progression. Additionally, researchers will track changes in CALR, MPL, and JAK-2 allelic burden over time (termed the "response rate"), as well as the longitudinal rate of change in ELN response rates over the course of the year-long study."
Answered by AI
What other scientific papers exist that mention Ropeginterferon alfa-2b?
"Ropeginterferon alfa-2b was first studied in 2015 at the Mayo Clinic in Arizona. As of now, there have been 20 completed trials and 7 active studies. A notable number of these latter investigations are being conducted in Vancouver, British Columbia."
Answered by AI
How many participants are accepted into this research project?
"In order to carry out this research, 160 patients that meet the required criteria must be recruited. The sponsor company, Medpace Inc., will delegate the trial between multiple locations like St. Paul's Hospital in Vancouver and Mayo Clinic in Phoenix."
Answered by AI
What are the typical conditions that Ropeginterferon alfa-2b is used to treat?
"The conditions of polycythemia vera (pv), splenomegaly, and thrombocythemia can all be treated by Ropeginterferon alfa-2b."
Answered by AI
In how many different geographical locations is this study being conducted?
"Right now, medical professionals are looking for patients to fill 14 different sites across North America. If you enroll in this trial, it would be convenient to choose a location near you to reduce travel time and costs."
Answered by AI
Can patients still enroll in this research project?
"The online clinical trials database does show that this study is still taking in patients. This trial began recruitment on August 25th, 2020 and the listing was updated December 30th, 2021. There are 160 total participants needed for this trial, spread out over 14 locations."
Answered by AI
Who else is applying?
What state do they live in?
Washington
How old are they?
65+
What site did they apply to?
St. Paul's Hospital
What portion of applicants met pre-screening criteria?
Met criteria
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