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An open-label, multi-centre, rollover study to characterise long-term safety and efficacy of etavopivat in adults, adolescents and children who have sickle cell disease or thalassaemia and have completed a treatment period in an etavopivat study

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-510805-27-00
Acronym
NN7535-7822
Enrollment
46
Registered
2024-11-15
Start date
2025-01-09
Completion date
Unknown
Last updated
2025-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sickle Cell Disease and Thalassaemia

Brief summary

Number of TEAEs, reported for each indication and age group separately, Number of adverse reactions, reported for each indication and age group separately

Detailed description

Annualised VOC rates, reported for each age group separately, Change in VOCs, reported for each age group separately, Change in Hb concentration, reported for each age group separately, Annualised number of hospitalisations, reported for each age group separately, Average length of stay of hospitalisations, reported for each age group separately, Change in Hb concentration, Number of RBC units transfused, reported for each indication separately, Change in RBC units transfused, reported for each indication separately

Interventions

Sponsors

Novo Nordisk A/S
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
0 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Number of TEAEs, reported for each indication and age group separately, Number of adverse reactions, reported for each indication and age group separately

Secondary

MeasureTime frame
Annualised VOC rates, reported for each age group separately, Change in VOCs, reported for each age group separately, Change in Hb concentration, reported for each age group separately, Annualised number of hospitalisations, reported for each age group separately, Average length of stay of hospitalisations, reported for each age group separately, Change in Hb concentration, Number of RBC units transfused, reported for each indication separately, Change in RBC units transfused, reported for each indication separately

Countries

France, Germany, Greece, Italy, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026