A Research Study Looking at Long-term Treatment With Etavopivat in People With Sickle Cell Disease or Thalassaemia
NCT06609226 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 480
Last updated 2026-03-24
Summary
Etavopivat is a new medicine under development for treating blood disorders like sickle cell disease and thalassaemia. Sickle cell disease and thalassaemia are inherited blood disorders that affect haemoglobin. Haemoglobin is the protein that carries oxygen through the body. This study is looking into how safe treatment with etavopivat is and how well it works over a long period of time. The study will last for up to 264 weeks, but it will end earlier if etavopivat is approved in the participant's country.
Conditions
Interventions
- DRUG
-
Etavopivat A
Participants will receive an oral dose of Etavopivat A.
- DRUG
-
Etavopivat B
Participants will receive an oral dose of Etavopivat B.
- DRUG
-
Etavopivat C
Participants will receive an oral dose of Etavopivat C.
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Clinical Transparency (dept. 2834) · Novo Nordisk A/S
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 2 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-01-10
- Primary Completion
- 2030-12-30
- Completion
- 2030-12-30
- FDA Drug
- Yes
Countries
- United States
- Canada
- Egypt
- France
- Germany
- Ghana
- Greece
- India
- Italy
- Kenya
- Lebanon
- Nigeria
- Oman
- Saudi Arabia
- Spain
- Turkey (Türkiye)
- United Kingdom
Study Locations
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