Clinical trial for Sickle Cell Disease
Official title A Research Study Looking at Long-term Treatment With Etavopivat in People With Sickle Cell Disease or Thalassaemia
ClinicalTrials.gov ID: NCT06609226
What this study is testing
What is Etavopivat A?
An investigational oral medicine being studied for sickle cell disease.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study will examine how safe etavopivat is and how well it works over a long period of time.
- Who it's for
- Adults and children who have sickle cell disease or thalassemia.
- What's involved
- Participants will receive etavopivat and have regular visits and tests to monitor safety and effectiveness.
- Time commitment
- The study can last up to 264 weeks, but may end earlier if the drug is approved in the participant’s country.
- Phase 3: a large, late-stage study
- Time commitment: about 264 weeks
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 2 and older
You may be able to join if
- Participant must have ongoing participation in an etavopivat parent study for treatment of sickle cell disease (SCD) or thalassaemia and have...
- 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 full dose of etavopivat before...
- Participants on hydroxyurea (HU), crizanlizumab or l-glutamine oral powder (Endari®) treatment at the time of consent may be eligible if they have...
You likely can't join if
- Any disorder, except for conditions associated with SCD or thalassaemia, which in the investigator's opinion might jeopardise participant's safety or...
- 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 discontinuation.
- Use of haemoglobin S (HbS) polymerisation inhibitors within participation of the parent study or anticipated need for this agent during this study.
- Use of an experimental selectin antagonist (e.g., monoclonal antibody or small molecule) within the parent study or anticipated need for such agents...
- Use of erythropoietin or other haematopoietic growth factor treatment for more than 4 consecutive weeks during the parent study or anticipated need...
See the full eligibility criteria
- Participant must have ongoing participation in an etavopivat parent study for treatment of sickle cell disease (SCD) or thalassaemia and have completed at least a treatment period of the parent study.
- 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 full dose of etavopivat before transferring.
- Participants on hydroxyurea (HU), crizanlizumab or l-glutamine oral powder (Endari®) treatment at the time of consent may be eligible if they have been on a stable dose in the parent study as defined at the...
- Any disorder, except for conditions associated with SCD or thalassaemia, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
- 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 discontinuation.
- Use of haemoglobin S (HbS) polymerisation inhibitors within participation of the parent study or anticipated need for this agent during this study.
- Use of an experimental selectin antagonist (e.g., monoclonal antibody or small molecule) within the parent study or anticipated need for such agents during this study.
- Use of erythropoietin or other haematopoietic growth factor treatment for more than 4 consecutive weeks during the parent study or anticipated need of such agents for a maintenance treatment during this study.
- Receiving or use of concomitant medications that are strong inducers of cytochrome P450 (CYP) 3A4 within 2 weeks of the transfer visit or anticipated need for such agents during the study.
- Current participation in a study that is not a designated parent study, or planned participation in any other clinical study, for the duration of FLORAL.
The study team makes the final eligibility decision.
Where it is enrolling
- Los Angeles, California, United States
- Oakland, California, United States
- Atlanta, Georgia, United States
- Chicago, Illinois, United States
- New York, New York, United States
- Durham, North Carolina, United States
- Houston, Texas, United States
- Milwaukee, Wisconsin, United States
- Alexandria, Egypt, Egypt
- Alsharkia, Egypt, Egypt
- Cairo, Egypt
- Cairo, Egypt, Egypt
- Créteil, France
- Lyon, France
- Paris, France
- Kintampo, Bono East, Ghana
- Accra, Ghana
- Larissa, Thessaly, Greece
- Athens, Greece
- Pátrai, Greece
+ 18 more site(s).
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, but confirm specifics with the study team.
How long does this study last?
The study runs about 264 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 2 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Los Angeles, California, United States; Oakland, California, United States; Atlanta, Georgia, United States; Chicago, Illinois, United States; New York, New York, United States; Durham, North Carolina, United States and 32 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.