Trial · NCT06547112
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 17 of 17
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Absolute number and relative proportions of CD34+ cell subsets by extended immunophenotypic profiling using multicolor fluorescence activated cell sorting (mFACS) on the apheresis product | From day 5 through day 8 (up to 4 days) | |
| Secondary | Number of participants with adverse events | From day 4 to end of study visit (estimated to be 15-26 days) | |
| Secondary | Change in concomitant medication use | From baseline through end of study visit (estimated to be 15-26 days) | |
| Secondary | Treatment compliance | From day 4 to end of study visit (estimated to be 15-26 days) | |
| Secondary | Number of participants who dropout due to adverse events | From day 4 to end of study visit (estimated to be 15-26 days) | |
| Secondary | Change in blood pressure | From baseline through end of study visit (estimated to be 15-26 days) | |
| Secondary | Change in temperature | From baseline through end of study visit (estimated to be 15-26 days) | |
| Secondary | Change in heart rate | From baseline through end of study visit (estimated to be 15-26 days) | |
| Secondary | Change in respiratory rate | From baseline through end of study visit (estimated to be 15-26 days) | |
| Secondary | Change in oxygen saturation at room air | From baseline through end of study visit (estimated to be 15-26 days) | |
| Secondary | Kinetics of PD assessed by the number of CD34+ cells/μL in peripheral blood | 0, +2, +4, +8, + 12 hours in Cohorts 1 and 2, +16 hours in Cohort 2, and, if needed +36 hours in Cohort 1 or +40 hours in Cohort 2 | |
| Secondary | Apheresis yields assessed by total CD34+ cells/kg in apheresis product | At 12 hours in Cohort 1 and 16 hours in Cohort 2 | |
| Secondary | Proportion of participants who mobilize ≥2.0 × 10^6 CD34+ cells/kg | In up to 2 apheresis sessions - from day 5 through day 8 (up to 4 days) | |
| Secondary | Proportion of participants who mobilize ≥5.0 × 10^6 CD34+ cells/kg | In up to 2 apheresis sessions - from day 5 through day 8 (up to 4 days) | |
| Secondary | Proportion of participants who mobilize ≥6.0 × 10^6 CD34+ cells/kg | In up to 2 apheresis sessions - from day 5 through day 8 (up to 4 days) | |
| Secondary | Proportion of participants who mobilize ≥2.0 × 10^6 CD34+ cells/kg | In up to 1 apheresis session - from day 5 through day 8 (up to 4 days) | |
| Secondary | Proportion of participants who mobilize ≥5.0 × 10^6 CD34+ cells/kg | In up to 1 apheresis session - from day 5 through day 8 (up to 4 days) |
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.
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GET https://conductscience.org/api/trials/v1/NCT06547112/registered