Senicapoc for Controlling Red Blood Cell Breakdown in Sickle Cell Disease
Tests senicapoc against placebo in sickle cell disease with ongoing red cell breakdown.
Plain-language title generated from the registry record
Registry title: Efficacy and Safety of SIL-8301 for Control of Hemolysis in a Uniform Sickle Cell Disease Endotype
Key facts
- Where
- Montreal and Toronto, CanadaSee the 4 sites
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 16 and 50 years old?
Source: NCT07282210, who can take part
Where in Canada
- Centre Hospitalier de l'Universite de Montreal (CHUM)Montreal, CanadaTaking people
- McGill University Health CentreMontreal, CanadaTaking people
- The Hospital for Sick ChildrenToronto, CanadaTaking people
- University Health Network, Toronto General HospitalToronto, CanadaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Biossil Inc.
- Trial code
- NCT07282210
- Record updated
- 2 November 2026
- Original description
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 evidence of ongoing hemolysis and a baseline Hb of 9.5 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. Eligible participants that complete the 24 weeks will have an opportunity to receive senicapoc for up to 2 years in an optional open label extension.Read full original descriptionShow less
A Multicenter, Randomized, Double-blind, Placebo-controlled Study With an Open-label Extension to Determine Efficacy and Safety of SIL-8301 in Sickle Cell Disease (SCD) Patients With a Predominantly Hemolytic Phenotype
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 evidence of ongoing hemolysis and a baseline Hb of 9.5 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. Eligible participants that complete the 24 weeks will have an opportunity to receive senicapoc for up to 2 years in an optional open label extension.
Inclusion: Documented diagnosis of sickle cell disease (SCD); 16-50 years of age; Hemoglobin (Hb) ≤ 9.5 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; Steady-state hemolysis; Current treatment with hydroxyurea.
Exclusion: Receipt of senicapoc in a previous investigational study; 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; Current Red Blood Cell (RBC) transfusion or exchange transfusion program.