Trial · NCT07282210
Efficacy and Safety of SIL-8301 for Control of Hemolysis in a Uniform Sickle Cell Disease Endotype
NCT07282210, Phase 2, Recruiting, Biossil Inc.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy and Safety of SIL-8301 for Control of Hemolysis in a Uniform Sickle Cell Disease Endotype. Trials, record NCT07282210. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07282210
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of SIL-8301 for Control of Hemolysis in a Uniform Sickle Cell Disease Endotype
- NCT number
- NCT07282210
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 65 participants, estimated
- Lead sponsor
- Biossil Inc.
- Conditions
- Sickle Cell Disease, Sickle Cell Anaemia, Sickle Cell Anemia
- Interventions
- Senicapoc, Placebo
- First posted
- 2025-12-15
- Last updated
- 2026-11-02
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Hb response rate | 24 Weeks | Proportion of participants achieving an increase in Hb of \> 1 g/dL from baseline |
| Secondary | Change from baseline in Hb (g/dL) | 24 Weeks | |
| Secondary | Change from baseline in lactate dehydrogenase (LDH) (u/L) | 24 Weeks | |
| Secondary | Change from baseline in indirect bilirubin (µmol/L) | 24 Weeks | |
| Secondary | Change from baseline in reticulocyte count (%) | 24 Weeks | |
| Secondary | Proportion of participants with a Hb increase of > 2g/dL from baseline | 24 Weeks | |
| Secondary | Percent change from baseline in urine albumin-creatinine ratio (uACR) | 24 Weeks | |
| Secondary | Change from baseline in overall score and subscale domain scores of the Participant-Reported Outcomes Measurement Information System (PROMIS) | 24 Weeks | The PROMIS-29 assessment for adult participants assesses depressive symptoms, anxiety, physical function, pain interference, fatigue, sleep disturbance, and ability to participate in social roles and activities. The PROMIS Pediatric-25 assessment for participants \<18 years of age assesses depressive symptoms, anxiety, physical function and mobility, pain interference, fatigue, and peer relationships. For both PROMIS assessments, a higher score indicates worse symptoms except for higher physical function values which indicate better physical function. |
| Secondary | Sickle cell disease complication rate | 24 Weeks | Proportion of participants experiencing at least one new or worsening hemolytic complication at any time during the study |
| Secondary | Proportion of participants with at least one category of improvement from baseline in Clinician and Patient Global Impression of Change | 24 Weeks |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07282210
GET https://conductscience.org/api/trials/v1/NCT07282210/registered