Trial · NCT06897358
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 18 of 18
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Safety & Tolerability | From baseline to the end of 24 weeks of treatment | To assess the number of AEs/SAEs and number of participants with AEs/SAEs |
| Secondary | Impact of leniolisib on lymphoproliferation measured as index lesions | From baseline to the end of 24 weeks of treatment | Percent change from baseline in lymphadenopathy measured as the sum of product of diameters (SPD) in the index lesions selected per the Cheson methodology |
| Secondary | Impact of leniolisib on lymphoproliferation measured as non-index lesions | From baseline to the end of 24 weeks of treatment | Percent change from baseline in lymphadenopathy measured as SPD of measurable non-index lesions selected as per the Cheson methodology |
| Secondary | Impact of leniolisib on spleen size | From baseline to the end of 24 weeks of treatment | Percent change from baseline in splenomegaly measured by three-dimensional (3D) volume and bi-dimensional (2D) size of spleen |
| Secondary | Impact of leniolisib on hemoglobin | From baseline to the end of 24 weeks of treatment | Hemoglobin will be evaluated over time |
| Secondary | Impact of leniolisib on platelets | From baseline to the end of 24 weeks of treatment | Platelet count will be evaluated over time |
| Secondary | Impact of leniolisib on neutrophils | From baseline to the end of 24 weeks of treatment | Absolute neutrophil counts will be evaluated over time |
| Secondary | Impact of leniolisib on GLILD or other PID-related ILD | From baseline to the end of 24 weeks of treatment | The change in CT evidence of GLILD or other PID-related ILD over time will be compared using the Hartmann Scoring Methodology |
| Secondary | Impact of leniolisib on pulmonary function in FEV1 | From baseline to the end of 24 weeks of treatment | Change in FEV1 will be evaluated |
| Secondary | Impact of leniolisib on pulmonary function in FVC | From baseline to the end of 24 weeks of treatment | Change in FVC will be evaluated |
| Secondary | Impact of leniolisib on pulmonary function in TLC | From baseline to the end of 24 weeks of treatment | Change in TLC will be evaluated |
| Secondary | Impact of leniolisib on pulmonary function in DLCO | From baseline to the end of 24 weeks of treatment | Change in DLCO will be evaluated |
| Secondary | Impact of leniolisib on B and T cell subsets of interest | From baseline to the end of 24 weeks of treatment | The percentages of naïve B cells, CD21low B cells, and T regulatory cells over time |
| Secondary | Impact of leniolisib on CXCL13 and soluble IL-2Rα levels | From baseline to the end of 24 weeks of treatment | The levels of CXCL13 and soluble IL-2Rα over time |
| Secondary | To assess the PK of leniolisib in CVID (Cmax) | From baseline to the end of 24 weeks of treatment | PK parameters for leniolisib defined by Cmax |
| Secondary | To assess the PK of leniolisib in CVID (AUC0-t) | From baseline to the end of 24 weeks of treatment | PK parameters for leniolisib defined by AUC0-t |
| Secondary | To assess the PK of leniolisib in CVID (Tmax) | From baseline to the end of 24 weeks of treatment | PK parameters for leniolisib defined by Tmax |
| Secondary | To assess the PK of leniolisib in CVID (T½) | From baseline to the end of 24 weeks of treatment | PK parameters for leniolisib defined by T½ |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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 list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT06897358/registered