At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Etavopivat A (drug), Etavopivat B (drug), Etavopivat C (drug)
- How long the study runs
- Study runs about 71 months (dates as stated)
- About the drug or intervention
- Etavopivat A — drug: Participants will receive an oral dose of Etavopivat A. · Etavopivat B — drug: Participants will receive an oral dose of Etavopivat B. · Etavopivat C — drug: Participants will receive an oral dose of Etavopivat C.
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 2 Years and over
- Who
- All
- Number of participants
- 480
- Started
- 2025-01-10
- Last checked
- 2026-09
Plain English Summary
What is this study?
- • Testing a new treatment for sickle cell disease
- • Phase3 - 480 participants
- • Etavopivat is a new medicine under development for treating blood disorders like sickle cell disease and thalassaemia
Who can take part?
- • Ages 2 Years and over
- • Diagnosed with sickle cell disease
Where?
- • London - Evelina London Children's Hospital - Haemophilia
- • London - Guy's Hospital - Haematology
- • London - Guy's Hospital
- • London - King's College Hospital - Paediatric Research
- • +4 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 2 Years and over
- Who can join: All genders
Treatment history
Treatments you must have had:
- ✓ derived clinical benefit from treatment with etavopivat, as determined by the investigator
What the study is looking for
- ✓Participant must have ongoing participation in an etavopivat parent study for treatment of sickle cell disease (SCD)...
- ✓Participant must have derived clinical benefit from treatment with etavopivat, as determined by the investigator.
- ✓Any participant with dose reduction or temporary discontinuation will need to be successfully rechallenged to the...
Who cannot take part
- ✗Any disorder, except for conditions associated with SCD or thalassaemia, which in the investigator's opinion might...
- ✗Participant withdrew or had permanent treatment discontinuation from an etavopivat clinical study.
- ✗Participants on permanent dose reduction (greater than \[\>\] 28 days or more) or ongoing temporary treatment...
- ✗Use of any of the following within the timeframes prior to the transfer visit as stated:
- ✗Use of haemoglobin S (HbS) polymerisation inhibitors within participation of the parent study or anticipated need...
See the full criteria
Where Is This Study? (8 UK sites)
Evelina London Children's Hospital - Haemophilia
London SE1 7EH, United Kingdom
Guy's Hospital - Haematology
London SE1 9RT, United Kingdom
Guy's Hospital
London SE1 9RT, United Kingdom
King's College Hospital - Paediatric Research
London SE5 9RS, United Kingdom
Kings College Hospital - Haematology
London SE5 9RS, United Kingdom
Imperial College London
London W12 0NN, United Kingdom
Manchester Royal Infirmary
Manchester M13 9WL, United Kingdom
Royal Hallamshire Hospital
Sheffield S10 2JF, United Kingdom
How to Get in Touch
Novo Nordisk
Sponsor contactCONTACT
