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Etavopivat for Sickle Cell Disease (Hibiscus 2 Trial)
Madera, CA
Phase 3
Recruiting
Research Sponsored by Novo Nordisk A/S
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age 12 years or above at the time of signing the informed consent
Confirmed diagnosis of sickle cell disease with documentation of SCD genotype (HbSS, HbSβ0-thalassemia or other sickle cell syndrome variants)
Must not have
Severe renal dysfunction or on chronic dialysis
Recent use or anticipated need for voxelotor or similar agent within 28 days prior to starting study treatment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (week 0) to week 52
Awards & highlights
Pivotal Trial
Summary
"This trial aims to see if a new medication called etavopivat can reduce the number of sickle cell pain crises in adults and adolescents with sickle cell disease. It will also look at
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Who is the study for?
This trial is for adults and adolescents with sickle cell disease. Participants should be experiencing vaso-occlusive crises, which are painful episodes due to blood vessel blockages. The study aims to include those who could benefit from reduced organ damage, improved exercise tolerance, and less fatigue.Check my eligibility
What is being tested?
The trial is testing Etavopivat's effectiveness in reducing the frequency of pain crises and improving overall health in sickle cell patients compared to a placebo. Patients will be randomly assigned to receive either Etavopivat or a placebo over approximately two years.See study design
What are the potential side effects?
As Etavopivat is new, side effects are still being studied but may include typical drug reactions such as nausea, headaches, or potential risks specific to its mechanism of action on red blood cells.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 12 years old or older.
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I have a confirmed diagnosis of sickle cell disease with a known genotype.
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I have had 1-15 pain crises due to sickle cell in the last year.
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Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have severe kidney problems or am on long-term dialysis.
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I haven't used, nor do I plan to use voxelotor or similar drugs within 28 days before starting the study treatment.
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I haven't had a blood transfusion in the last 60 days or my HbA1c is under 10%.
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I haven't taken strong CYP3A4 inducers in the last 2 weeks.
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My liver tests are not within normal limits.
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I have received cell-based therapy before.
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I haven't used erythropoietin or blood cell growth factors in the last 28 days.
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I have had 6 or more blood transfusions in the last year.
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I walked less than 100 meters in a 6-minute walk test.
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Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline (week 0) to week 52
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (week 0) to week 52
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in distance travelled during the 6-minute walking test (6MWT)
Change in standardised T-score on the Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue 7a Scale
Number of adjudicated Vaso-occlusive crisis (VOC) events with a medical contact
+1 moreSecondary study objectives
Change in Haemoglobin (Hb) greater than 1 grams per decilitre (g/dL)
Change in N-terminal pro b-type natriuretic peptide (NT-pro-BNP)
Change in absolute reticulocyte count
+8 moreAwards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: EtavopivatExperimental Treatment1 Intervention
Participants will be randomised to receive oral dose of Etavopivat.
Group II: PlaceboPlacebo Group1 Intervention
Participants will be randomised to receive oral dose of placebo.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Etavopivat
2024
Completed Phase 1
~40
Find a Location
Closest Location:Univ of OK Health Sciences Ctr· Oklahoma City, OK· 159 miles
Who is running the clinical trial?
Novo Nordisk A/SLead Sponsor
1,575 Previous Clinical Trials
3,831,546 Total Patients Enrolled
Clinical Transparency (dept. 2834)Study DirectorNovo Nordisk A/S
153 Previous Clinical Trials
1,540,548 Total Patients Enrolled