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Etavopivat for Sickle Cell Disease
Study Summary
This trial will study a new drug to treat sickle cell disease & inherited hemoglobinopathies. The aim is to reduce red blood cell sickling & hemolysis to improve blood flow & reduce anemia. #SickleCell #Hemoglobinopathies #Etavopivat
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Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I need regular blood transfusions to manage my condition.I have not had a spleen disorder in the last 14 days.I have had swollen fingers or toes in the last 14 days.I have severe kidney problems or am on long-term dialysis.I have not had chemotherapy or radiation in the last 2 years.I have had a stroke or brain bleed in the last 2 years.I have sickle cell disease with either HbSS or HbS/β0 thalassemia.I have had major surgery on my stomach or small intestine.I am currently pregnant or breastfeeding.I am currently being treated for a serious infection.I have received a red blood cell transfusion in the last 60 days.I do not have serious heart or lung conditions.I have been on a stable dose of hydroxyurea for 3 months without blood-related side effects.I have liver problems.
- Group 1: Etavopivat
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Is this experiment accessible to adults over the age of eighteen?
"The minimum age for eligibility in this medical trial is 12, whereas the upper limit of participation has been set at 21."
Has Etavopivat been given the greenlight by the FDA?
"The safety of etavopivat was assessed by our team at Power and scored a 2. As this is only in its second phase, there is some research that supports the drug's security but not yet any evidence to verify efficacy."
Are there still opportunities for people to join this experiment?
"Data hosted on clinicaltrials.gov reveals that the recruitment period for this investigation has expired, last edited on February 10th 2023. Despite this trial not being open to new participants, there are an abundance of other trials with 188 studies accepting applicants currently."
Who should consider participating in this clinical investigation?
"In order to be considered for this trial, a potential participant must have been diagnosed with sickle cell disease and lie in the 12-21 age range. In total, around a dozen patients are being admitted into the experiment."
What is the ambition of this clinical exploration?
"Forma Therapeutics, Inc., the clinical trial sponsor, has reported that their primary outcome will be measuring effect of etavopivat on oxygen ejection fraction (OEF) over a 24-week time frame. Secondary outcomes include: examining correlation between OEF and change in Hb levels; exploring connection between cerebral metabolic rate of oxygen (CMRO2) and alteration in Hb levels; as well as evaluation of adverse events experienced by participants with SCD. Finally, they aim to furnish tabulated information regarding deaths attributed to TEAEs or drug discontinuation caused by these events."
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