SIL-8301 (senicapoc) is being developed for the chronic treatment of patients with sickle cell disease in both adults and children. this study wants to compare the effects of senicapoc to dummy treatment (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.
Official registry: https://clinicaltrials.gov/study/NCT07282210 · Biossil Inc. · enrollment listed as 65
Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
If you join, the listed intervention(s) are Senicapoc, or Placebo. The registry lists allocation as randomized. SIL-8301 (senicapoc) is being developed for the chronic treatment of patients with sickle cell disease in both adults and children.
They plan to enroll about 65 people at 4 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.
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
Interventions: Senicapoc, Placebo
Primary outcome (registry wording): Hb response rate
Head of Clinical Operations
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
This study is not a treatment protocol and no experimental treatments are involved. Study participants may be seen as needed for clinical, translational and basic research studies, or as medically indicated.
NCT00081523 · Official ClinicalTrials.gov record · National Heart, Lung, and Blood Institute (NHLBI)
This study will collect representative blood samples from healthy children and adults and from children and adults who have unique red blood cell features that are related to sickle cell disease. Sickle cell disease is a blood disease that limits the ability of red blood cells to carry oxygen throughout the body.
NCT00542230 · Official ClinicalTrials.gov record · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Background: Some people with the same disorder on a genetic level have more complications than others. Researchers want to look for a link between the PKLR gene and sickle cell disease (SCD) symptoms.
NCT03685721 · Official ClinicalTrials.gov record · National Heart, Lung, and Blood Institute (NHLBI)
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary