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Sickle Cell DiseaseAugust 2019

What the HOPE Trial Found — Voxelotor for Sickle Cell Disease

HOPE tested voxelotor, a daily pill that prevents sickled hemoglobin from clumping, in 274 people with sickle cell disease. After 24 weeks, the higher dose raised hemoglobin levels and reduced markers of red-cell breakdown.

What the trial was testing

The HOPE enrolled 449 patients with sickle cell disease. The study was sponsored by Pfizer and tracked outcomes across the full group of patients who matched the trial's eligibility profile.

It was a large trial designed to confirm whether the treatment works well enough for wider use. Trials at this stage are designed to produce evidence regulators and physicians can act on — not just observations to follow up later.

What the results showed

51% had a meaningful hemoglobin rise on voxelotor vs. 7% on the comparison pill.

New England Journal of Medicine · 2019 · NCT03036813

These findings — that of patients had a hemoglobin rise of more than 1 g/dL on voxelotor 1500 mg over 24 weeks — were published in the New England Journal of Medicine and represent the headline result of the study.

Researchers tracked outcomes across 449 patients enrolled in the trial. The result was consistent enough across the group that the team felt confident reporting it.

What this means for patients

For patients with sickle cell disease, this result changes the calculus on what to ask their care team about. Whether it changes day-to-day care depends on factors like disease subtype, prior treatments, and where the patient is in their care journey.

What you can do now

Voxelotor (Oxbryta) was FDA-approved based on this study. However, in 2024 the manufacturer withdrew it from the U.S. market because of concerns that it may increase the risk of pain crises and death. It is no longer available. Ask your hematologist about other sickle cell options including hydroxyurea, L-glutamine, crizanlizumab, and gene therapy.

Eligibility for the treatments mentioned above depends on specific test results and clinical history. Bring this summary, the trial name, and your most recent labs or pathology report to your next visit.