Efficacy and Safety of SIL-8301 for Control of Hemolysis in a Uniform Sickle Cell Disease Endotype
Recruiting · NCT07282210 · Interventional (participants receive a specific treatment) · Lead sponsor: Biossil Inc.
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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
Where it is running
4 locations listed.
- The Hospital for Sick Children - Toronto, Ontario, Canada
- University Health Network, Toronto General Hospital - Toronto, Ontario, Canada
- Centre Hospitalier de l'Université de Montréal (CHUM) - Montreal, Quebec, Canada
- McGill University Health Centre - Montreal, Quebec, Canada