Trial · NCT04720261
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | To evaluate the feasibility of a personalized caplacizumab regimen in aTTP based on ADAMTS13 activity monitoring assessed by a composite criteria including mortality, refractoriness and/or exacerbation at 30 days post-PE treatment | 30 days post-PE treatment | composite endpoint defined by the occurrence of at least one the following events during the 30 days post-PE treatment: death, refractoriness or exacerbation. |
| Secondary | Response to treatment (platelet count recovery) | 30 days post-PE treatment | to platelet count recovery (as defined by a platelet count ≥ 150 G/L with a subsequent interruption of daily PE within 5 days) |
| Secondary | Durable remission achievement | 90 days post-PE treatment | Occurrence of durable remission achievement (platelet count ≥ 150 G/L for ≥ 30 consecutive days following PE interruption); |
| Secondary | Mortality at D90 post-PE treatment | 90 days post-PE treatment | Occurrence of death within 90 days post-PE treatment |
| Secondary | Refractoriness at D30 post-PE treatment | Day 30 post-PE treatment | Occurrence of refractoriness at D30 post-PE treatment; |
| Secondary | Exacerbation at D30 post-PE treatment | Day 30 post-PE treatment | Occurrence of exacerbations at D30 post-PE treatment |
| Secondary | Duration of plasma exchange (PE) treatment and the associated plasma volumes | 30 days | Duration of daily PE with the corresponding plasma volume |
| Secondary | Duration of plasma exchange (PE) treatment and the associated plasma | 30 days | Total number of PE and the corresponding plasma volume during the full study drug treatment period |
| Secondary | Occurrence of neurological sequelae treatment | Day 90 post-PE treatment | Neurological assessment based on Rankin score |
| Secondary | Evaluate the Quality of life | Day 90 post-PE treatment | Quality of life based on global post-traumatic score (PCL-S SCALE) at baseline, D90 post-PE treatment |
| Secondary | Evaluate the cost of the strategy | Day 90 post-PE treatment | Costs of the patients' management (Direct hospital medical expenses, Suppléments, direct costs of home care, caplacizumab injections, rehospitalizations) of patients treated with the regimen according to the study |
| Secondary | To perform a safety analysis | 90 days post-PE treatment | Occurrence of AE and SAE during the study |
| Secondary | Occurrence of cognitive sequelae treatment | Day 90 post-PE treatment | Cognitive assessment based on MMS score |
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/NCT04720261/registered