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Voxelotor for Sickle Cell Anemia (VoxSCAN Trial)
VoxSCAN Trial Summary
This trial will test whether the new drug Voxelotor can improve hemoglobin levels and reduce the incidence of worsening anemia in patients with sickle cell disease.
VoxSCAN Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowVoxSCAN Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2022 Phase 4 trial • 25 Patients • NCT04400487VoxSCAN Trial Design
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- I have sickle cell disease (either HbSS or HbS/β^0 thalassemia).My liver enzyme (ALT) levels are more than four times the normal limit.I am a woman who can have children and have a negative pregnancy test before starting the study drug.I agree to use contraception or abstain from sex during and for 30 days after the study.I don't have conditions affecting drug absorption or active serious infections, and haven't had cancer treatment in the past 2 years.I, or my guardian, have signed the consent forms as per the guidelines.I can take pills and will follow the treatment and testing schedule.I am on chronic dialysis or my creatinine level is 1.5 mg/dL or higher.I do not have significant heart disease or conditions affecting my heart's rhythm.I have had a blood transfusion or experienced specific sickle cell complications recently.I am between 4 and 30 years old.I have not taken any experimental drugs recently, don't smoke heavily, and can follow the study's procedures.I have been on a stable dose of hydroxyurea for 3 months without blood-related side effects.I agree to use birth control or abstain from sex during and 30 days after the study.
- Group 1: Voxelotor
- 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 investigation into a new therapeutic approach?
"Ever since 2016, Voxelotor has been subject to rigorous medical research. Global Blood Therapeutics were the first sponsor of a study in 2016 that involved 155 participants and granted it Phase 2 drug approval. Currently, 7 studies are being conducted around 39 cities and 14 countries worldwide."
Has there been any prior research on the efficacy of Voxelotor?
"Presently, there are seven investigations into the efficacy of Voxelotor. Of those studies, three occupy their final phase in the clinical trial process. Whilst Philadelphia is a hub for this research, 139 other sites across America also facilitate trials with this medication."
Is enlistment currently available for this trial?
"Affirmative. The records provided by clinicaltrials.gov suggest that the recruitment for this medical study is ongoing, with an initial posting on March 28th 2022 and most recent update on August 23rd 2022. A total of 12 patients are needed from two distinct sites to complete the trial."
Has Voxelotor received clearance from the FDA?
"Limited clinical data exists to attest to the safety of Voxelotor, thus it received a rating of 2. This Phase 2 trial has yet to reveal any evidence that supports its efficacy."
Is this research program open to participants under the age of seventy?
"Eligible candidates for this investigation must be aged between 4 and 17 years old. Additionally, there are 212 trials involving minors and 239 studies dedicated to patients above the age of 65."
How many participants have enrolled in this research project?
"Affirmative. Clinicaltrials.gov confirms that, as of August 23rd 2022, this medical experiment is actively recruiting patients to fill 12 positions in 2 different locations since its commencement on March 28th 2022."
Is there an opportunity for me to join this investigation?
"This medical trial is accepting up to twelve participants between the ages of four and seventeen who have been diagnosed with anemia, sickle cell. Several criteria must be met for consideration including: written informed parental/guardian consent and participant assent acquired in accordance with International Conference on Harmonization (ICH) guidelines, stability of hydroxyurea therapy dosage within three months preceding study commencement, ability to orally ingest medications combined with willingness to adhere to daily voxelotor administration and scheduled DCS/NIRS assessments, negative pregnancy test at screening if female patient is sexually active or barriers methods such as contraception required by male patients during their participation"
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