NCT07282210RecruitingPhase 2
Efficacy and Safety of SIL-8301 for Control of Hemolysis in a Uniform Sickle Cell Disease Endotype
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
Source: ClinicalTrials.gov · Last updated 2 Nov 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 65 (estimated)
- First submitted
- 13 Nov 2025
- Start date
- Nov 2026
- Primary completion date
- Oct 2029
- Lead sponsor
- Biossil Inc.
- Diseases
- Sickle cell disease
- NCT number
- NCT07282210
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 65
- From Nov 2026 to the primary completion date, Oct 2029
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Receipt of senicapoc in a previous investigational study
Other illness
- 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
Other
- Current Red Blood Cell (RBC) transfusion or exchange transfusion program
Who the study is looking for
- 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
Age in the registry: 16 years to 50 years · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centre Hospitalier de l'Universite de Montreal (CHUM) Coordinator of this site? Confirm its status | Montreal | Canada | Recruiting |
| McGill University Health Centre Coordinator of this site? Confirm its status | Montreal | Canada | Recruiting |
| The Hospital for Sick Children Coordinator of this site? Confirm its status | Toronto | Canada | Recruiting |
| University Health Network, Toronto General Hospital Coordinator of this site? Confirm its status | Toronto | Canada | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.