Sickle Cell Disease study: Senicapoc
Official title Efficacy and Safety of SIL-8301 for Control of Hemolysis in a Uniform Sickle Cell Disease Endotype
ClinicalTrials.gov ID: NCT07282210
What this study is testing
What is Senicapoc?
An investigational oral tablet being studied as a potential chronic treatment for sickle cell disease. It is designed to block the Gardos potassium channel in red blood cells, which may reduce cell dehydration and hemolysis.
Also referred to as SIL-8301.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study will compare senicapoc to a placebo to see if it improves hemolysis in sickle cell disease patients who still have low hemoglobin despite hydroxyurea.
- Who it's for
- Adults or children with sickle cell disease, fewer than 2 painful crises per year, a hemolytic complication, hemoglobin 9 g/dL or less, and already taking hydroxyurea.
- What's involved
- Participants will take a daily pill of senicapoc or a matching placebo while continuing their hydroxyurea treatment for up to 24 weeks.
- Time commitment
- The trial lasts about 24 weeks and includes regular study visits during that time.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 2 years
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 16 to 50
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility criteria
- 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
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- Toronto, Ontario, Canada
- Montreal, Quebec, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The study runs about 2 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 16 years to 50 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Toronto, Ontario, Canada; Montreal, Quebec, Canada. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.