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Mitapivat for Thalassemia (ENERGIZE-T Trial)
ENERGIZE-T Trial Summary
This trial will compare the effect of the drug mitapivat versus a placebo on transfusion burden in people with transfusion-dependent alpha- or beta-thalassemia.
ENERGIZE-T Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowENERGIZE-T Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.ENERGIZE-T Trial Design
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Who is running the clinical trial?
Media Library
- My kidney function is reduced, with an eGFR less than 45 mL/min/1.73m^2.I have a liver or bile duct disorder.I haven't had cancer, except for certain skin, cervical, or breast cancers, in the last 5 years.I have a confirmed diagnosis of sickle cell disease or hemoglobin C disease.I have needed 6 to 20 blood transfusions in the last 6 months without going more than 6 weeks without one.I haven't had major surgery in the last 6 months and don't plan any during the study.I am currently on medication for an infection.I have been diagnosed with thalassemia based on DNA analysis.I haven't had blood cell boosters in the last 36 weeks.I have been treated with luspatercept, and my last dose was over 36 weeks ago.I haven't taken anabolic steroids in the last 4 weeks, but I may be on stable testosterone treatment for low testosterone.I am allergic to mitapivat or its ingredients.I do not have any health conditions that my doctor thinks would make this study unsafe for me.I have had gene therapy or a bone marrow/stem cell transplant before.My hydroxyurea dose has been the same for at least 16 weeks.I haven't had serious heart or lung problems in the last 6 months.I have not taken strong CYP3A4/5 inhibitors or inducers for the required time before joining.
- Group 1: Placebo
- Group 2: Mitapivat
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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
How many different staff members are managing this research project?
"There are 17 sites across the country where this trial is taking place. If you enroll in the study, pick a location that is close to minimize travel requirements."
Are there any opportunities for patients to enroll in this research project?
"From what is published on clinicaltrials.gov, it appears that this experiment is still looking for individuals to take part in it. The trial was first advertised on 11/30/2021 and the most recent update was 11/8/2022."
Could you please provide a list of other clinical trials that have utilized Mitapivat?
"The first study investigating mitapivat was completed in 2015 at Stanford University. As of now, 12 studies have been wrapped up with 9 more currently underway. The majority of these ongoing investigations are taking place out of Philadelphia, Pennsylvania."
Could you share how many test subjects are involved in this experiment?
"The information available on clinicaltrials.gov supports that this study is looking for volunteers. The trial was originally posted on November 30th, 2021 and the most recent update occurred on November 8th, 2022. A total of 240 patients will be accepted at 17 different sites."
Has this investigation been done before?
"Agios Pharmaceuticals, Inc. first sponsored a clinical trial for Mitapivat in 2015. Since the initial study with 52 patients, there have been 9 more trials conducted in 54 cities across 28 countries."
Are there any severe side effects associated with taking Mitapivat?
"Mitapivat's safety was given a 3 because there is clinical evidence affirming its efficacy and multiple rounds of data to support its safety."
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