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Etavopivat for Sickle Cell Anemia (FLORAL Trial)
Phase 3
Waitlist Available
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (week 0 of floral) to end of study (week 264, or earlier)
Awards & highlights
Pivotal Trial
No Placebo-Only Group
Summary
"This trial is testing a new medication called Etavopivat for treating blood disorders like sickle cell disease and thalassaemia. The medication aims to improve the function of haemoglobin,
Who is the study for?
This trial is for individuals with inherited blood disorders, specifically sickle cell disease or thalassaemia. Participants will be involved in the study for up to 264 weeks unless etavopivat gets approved sooner in their country.
What is being tested?
The study tests long-term safety and effectiveness of a new medication called etavopivat, which aims to treat anemia caused by sickle cell disease and thalassaemia by improving haemoglobin function.
What are the potential side effects?
As etavopivat is under development, specific side effects are being studied. Generally, potential side effects may include issues related to blood chemistry changes or reactions at the site of administration.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline (week 0 of floral) to end of study (week 264, or earlier)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (week 0 of floral) to end of study (week 264, or earlier)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of adverse reactions, reported for each indication and age group separately
Number of treatment emergent adverse events (TEAEs), reported for each indication and age group separately
Secondary study objectives
Annualised number of hospitalisations, reported for each age group separately
Annualised vaso-occlusive crisis (VOC) rates, reported for each age group separately
Average length of stay of hospitalisations, reported for each age group separately
+5 moreAwards & Highlights
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
5Treatment groups
Experimental Treatment
Group I: Participants ≥ 12 years old with transfusion-dependent thalassaemiaExperimental Treatment1 Intervention
Participants will receive an oral dose of Etavopivat A.
Group II: Participants ≥ 12 years old with sickle cell disease on chronic red blood cell (RBC) transfusionsExperimental Treatment1 Intervention
Participants will receive an oral dose of Etavopivat A.
Group III: Participants ≥ 12 years old with non-transfusion dependent thalassaemiaExperimental Treatment1 Intervention
Participants will receive an oral dose of Etavopivat A.
Group IV: Participants ≥ 11 months to less than (<) 12 years old with sickle cell diseaseExperimental Treatment2 Interventions
Participants ≥ 12 years of age will receive an oral dose of Etavopivat A and participants \< 12 years of age will receive an oral dose of Etavopivat B.
Group V: Participants greater than or equal to (≥) 12 years old with sickle cell diseaseExperimental Treatment1 Intervention
Participants will receive an oral dose of Etavopivat A.
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Who is running the clinical trial?
Novo Nordisk A/SLead Sponsor
1,560 Previous Clinical Trials
3,646,182 Total Patients Enrolled
2 Trials studying Anemia
78 Patients Enrolled for Anemia
Clinical Transparency (dept. 2834)Study DirectorNovo Nordisk A/S
141 Previous Clinical Trials
1,355,588 Total Patients Enrolled