Trial · NCT07110844
Registered outcomes33
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
21 to 33 of 33
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Secondary | Number of participants with liver response after treatment | 6 months and 18 months | Liver response is defined as 50% decrease in abnormal alkaline phosphatase value. |
| Secondary | Number of No Responses in the liver after treatment | 6 months and 18 months | No response in the liver is defined as ≤30% reduction in alkaline phosphatase (ALP) from baseline. |
| Secondary | Number of Partial Responses (PR) in participants who experienced liver response after treatment | 6 months and 18 months | Partial Response in the liver is defined as 31-60% reduction in ALP from baseline. |
| Secondary | Number of Very Good Partial Responses (VGPR) in participants who experienced liver response after treatment | 6 months and 18 months | VGPR in the liver is defined as \>60% reduction in ALP from baseline to a nadir \>2x lower limit of normal (LLN) |
| Secondary | Number of Complete Response (CR) in participants who experienced liver response after treatment | 6 months and 18 months | Complete Response in the liver is defined as Nadir ALP ≤2X LLN |
| Secondary | Number of participants with liver progression after treatment | 6 months and 18 months | Liver progression is defined as 50% increase of ALP from nadir value |
| Other | Hematologic event-free survival (Heme-EFS) | Throughout Cycle 2 and Cycle 6 (each cycle is 28 days) on Day 1; End of treatment visit (up to 6 months from treatment initiation), Post treatment follow-up (up to 18 months from treatment initiation) | Heme-EFS will be calculated as a time-to-event endpoint using Kaplan-Meier method. |
| Other | CD4 cell count | Baseline until 18 months from treatment initiation | CD4 cells will be measured in participants before and after treatment. |
| Other | CD8 cell count | Baseline until 18 months from treatment initiation | CD8 cells will be measured in participants before and after treatment. |
| Other | CD19 cell count | Baseline until 18 months from treatment initiation | CD19 cells will be measured in participants before and after treatment. |
| Other | IgG level | Baseline until 18 months from treatment initiation | IgG titers will be measured in participants before and after treatment. |
| Other | IgA level | Baseline until 18 months from treatment initiation | IgA titers will be measured in participants before and after treatment. |
| Other | IgM level | Baseline until 18 months from treatment initiation | IgM titers will be measured in participants before and after treatment. |
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/NCT07110844/registered?page=2