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Efficacy and Safety of SIL-8301 for Control of Hemolysis in a Uniform Sickle Cell Disease Endotype

RecruitingPhase 2Ages 16 Years - 35 YearsAllBiossil Inc.
NCT07282210 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

SIL-8301 (senicapoc) is being developed for the chronic treatment of patients with sickle cell disease in both adults and children. The purpose of this study is to compare the effects of senicapoc to placebo in patients with sickle cell disease that have had fewer than 2 acute sickle-related painful crises per year over the preceding 2 years, and have a predominantly hemolytic phenotype, defined as presence or history of at least one hemolytic complication and a baseline Hb of 9 g/dL or less, despite receiving hydroxyurea (an oral drug used for treatment of sickle cell disease) as standard of care. Participants will take senicapoc or matching placebo daily and continue on hydroxyurea as prescribed for up to 24 weeks.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Documented diagnosis of sickle cell disease * 16-35 years of age * Hb ≤ 9.0 g/dL * History of no more than 1 acute SCD-related painful crises requiring a visit to a medical facility per year within the preceding 2 years * History of at least one hemolytic complication * Current treatment with hydroxyurea Exclusion Criteria: * Receipt of senicapoc in a previous investigational study * Current Red Blood Cell (RBC) transfusion or exchange transfusion program * History of pulmonary hypertension * Active cardiovascular, neurologic, endocrine, hepatic, or renal disorders * Diagnosis of cancer (except non-melanoma skin cancer in situ, cervical cancer in situ, or breast cancer in situ) within the last 5 years * History of liver disease
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What it tests

  • Senicapoc
  • Placebo
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Where

4 sites
The Hospital for Sick Children
Toronto, Canada
University Health Network, Toronto General Hospital
Toronto, Canada
Centre Hospitalier de l'Université de Montréal (CHUM)
Montreal, Canada
McGill University Health Centre
Montreal, Canada
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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