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A research study to evaluate how well etavopivat works in people with sickle cell disease - Hibiscus 2
EU CTIS ID: 2023-509175-16-00
What this study is testing
To demonstrate superiority of treatment with etavopivat versus placebo in adolescents and adults with sickle cell disease
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Male or female
- Age 12 years or above at the time of signing the informed consent
- Confirmed diagnosis of sickle cell disease (SCD): Documentation of SCD genotype (HbSS, HbSβ0-thalassemia or other sickle cell syndrome variants) based on prior history of laboratory testing or screening test results from central laboratory.
- Have 2−15 episodes of documented vaso-occlusive crises (VOCs) within the 12 months prior to screening. Documentation must exist in the participant’s medical record prior to randomisation. Events based solely on participant recall without supporting documentation should not be counted towards eligibility.
- Hb ≥5.0 and ≤10.0 g/dL (≥50 and ≤100 g/L) at screening.
You likely can't join if
- Use of voxelotor or similar agent within 28 days prior to starting study treatment or anticipated need for this agent during the study
- Severe renal dysfunction (estimated glomerular filtration rate [eGFR] at screening, calculated by the central laboratory <30 mL/min/1.73 m2) or on chronic dialysis.
- Travelled distance on standardized 6-minute walking test below 100m at screening.
- Use of a selectin antagonist (e.g., crizanlizumab, monoclonal antibody or small molecule) within 28 days or 5 half-lives (whichever is longer) prior to starting study treatment or anticipated need for such agents during the study.
- Receiving regularly scheduled blood (RBC) transfusion therapy (also termed chronic, prophylactic, or preventive transfusion) or ≥6 transfusion events in the previous 12 months (i.e., an average of 1 transfusion event every 60 days).
- Participants who have received an RBC transfusion for any reason within 60 days of the screening period or 60 days of the randomisation day are only eligible if HbA (adult Hb) <10% by Hb electrophoresis is documented prior to starting study treatment.
See the full eligibility criteria
- Male or female
- Age 12 years or above at the time of signing the informed consent
- Confirmed diagnosis of sickle cell disease (SCD): Documentation of SCD genotype (HbSS, HbSβ0-thalassemia or other sickle cell syndrome variants) based on prior history of laboratory testing or screening test results from central laboratory.
- Have 2−15 episodes of documented vaso-occlusive crises (VOCs) within the 12 months prior to screening. Documentation must exist in the participant’s medical record prior to randomisation. Events based solely on participant recall without supporting documentation should not be counted towards eligibility.
- Hb ≥5.0 and ≤10.0 g/dL (≥50 and ≤100 g/L) at screening.
- Use of voxelotor or similar agent within 28 days prior to starting study treatment or anticipated need for this agent during the study
- Severe renal dysfunction (estimated glomerular filtration rate [eGFR] at screening, calculated by the central laboratory <30 mL/min/1.73 m2) or on chronic dialysis.
- Travelled distance on standardized 6-minute walking test below 100m at screening.
- Use of a selectin antagonist (e.g., crizanlizumab, monoclonal antibody or small molecule) within 28 days or 5 half-lives (whichever is longer) prior to starting study treatment or anticipated need for such agents during the study.
- Receiving regularly scheduled blood (RBC) transfusion therapy (also termed chronic, prophylactic, or preventive transfusion) or ≥6 transfusion events in the previous 12 months (i.e., an average of 1 transfusion event every 60 days).
- Participants who have received an RBC transfusion for any reason within 60 days of the screening period or 60 days of the randomisation day are only eligible if HbA (adult Hb) <10% by Hb electrophoresis is documented prior to starting study treatment.
- Receiving or use of concomitant medications that are strong inducers of CYP3A4 within 2 weeks of starting study treatment or anticipated need for such agents during the study.
- Use of erythropoietin or other haematopoietic growth factor treatment within 28 days of starting study treatment or anticipated need for such agents during the study.
- Receipt of prior cellular-based therapy (e.g., haematopoietic cell transplant, gene modification therapy).
- Hepatic dysfunction characterized by: Alanine aminotransferase (ALT) >4.0 × upper limit of normal (ULN) or Direct bilirubin >3.0 × ULN.
- Participants who are not taking or are unable to take antimalarial prophylaxis at the time of consent and during the study if they live in areas of endemic malaria where prophylaxis is recommended.
The study team makes the final eligibility decision.
Where it's taking place
- Turkey
- Australia
- Uganda
- Saudi Arabia
- Oman
- Brazil
- Nigeria
- India
- United States
- Lebanon
- Canada
- Ghana
- United Kingdom
- Colombia
- Kenya
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years, 0-17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Turkey; Australia; Uganda; Saudi Arabia; Oman; Brazil and 9 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.