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Trial · NCT05785468

A Retrospective, Observational Study on the Response to Caplacizumab Treatment in aTTP Patients: the Italian Experience (ROSCAPLI)

NCT05785468, Unknown, Fondazione Policlinico Universitario Agostino Gemelli IRCCS

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. A Retrospective, Observational Study on the Response to Caplacizumab Treatment in aTTP Patients: the Italian Experience (ROSCAPLI). Trials, record NCT05785468. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05785468

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
A Retrospective, Observational Study on the Response to Caplacizumab Treatment in aTTP Patients: the Italian Experience (ROSCAPLI)
NCT number
NCT05785468
Status
Unknown
Enrollment
1 participants, estimated
Lead sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Conditions
Thrombotic Thrombocytopenic Purpura
Interventions
Caplacizumab
First posted
2023-03-27
Last updated
2023-03-27

Source ClinicalTrials.gov

Registered outcomes7

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
Primarydescription and quantification of clinical response in terms of platelet count recovery in patients with aTTP treated t with caplacizumab18 months
The primary objective in this study is the description of clinical response in terms of platelet count recovery in patients with aTTP treated with caplacizumab , in addition to PEX and immunosuppression in the real-world setting.
PrimaryThe primary objective in this study is the quantification of clinical response in terms of platelet count recovery in patients with aTTP treated t with caplacizumab18 months
The primary objective in this study is the quantification of clinical response in terms of platelet count recovery in patients with aTTP treated with caplacizumab , in addition to PEX and immunosuppression in the real-world setting.
Secondaryevaluation of number of exacerbations,rate of relapse and TTP-related mortality18 monthsSecondary objectives include: a) Number of exacerbations, defined as recurrent thrombocytopenia within 30 days after the end of therapy;
Secondaryevaluation of number of exacerbations,rate of relapse and TTP-related mortality18 monthsSecondary objectives include: b) Rate of relapse, defined as a TTP event occurring more than 30 days after the end of daily plasma exchange;
Secondaryevaluation of number of exacerbations,rate of relapse and TTP-related mortality18 months
Secondary objectives include: c) Refractoriness; defined by the lack of a doubling of platelet count after 4 days of treatment and a lactate dehydrogenase level that remained above the upper limit of the normal range
Secondaryevaluation of number of exacerbations,rate of relapse and TTP-related mortality18 monthsSecondary objectives include: d) TTP-related mortality
Secondaryevaluation of number of exacerbations,rate of relapse and TTP-related mortality18 monthsSecondary objectives include: e) Evaluation of adverse events

Outcomes0

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.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

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/NCT05785468

GET https://conductscience.org/api/trials/v1/NCT05785468/registered