Retrospective Study on Caplacizumab-treated Pediatric Patients With Immune-mediated Thrombocytopenic Purpura (iTTP)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

4 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-06-08

Study Completion Date

2022-10-28

Brief Summary

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The purpose of this multi-country, retrospective data collection study (chart review) is to describe the effectiveness and safety of caplacizumab in pediatric patients with iTTP.

Detailed Description

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Pediatric patients who received caplacizumab will be identified for enrollment in the chart review. The eligibility period starts on August 30, 2018 in the United Kingdom (UK) and France and February 6, 2019 for the United States (US).

Data collection is fully retrospective and will be anchored to the patient's index event date. The index event date is defined as the date the patient initiated caplacizumab treatment. The study period begins at the index date and ends at the earliest date of chart abstraction initiation, 12 weeks after last dose of caplacizumab treatment, date of death, or loss to follow-upwhich ever comes first .

Conditions

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Immune-mediated Thrombocytopenic Purpura

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Interventions

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Caplacizumab

as in real world practice

Intervention Type DRUG

Other Intervention Names

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Cablivi®

Eligibility Criteria

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Inclusion Criteria

* Patient's aged ≤18 years at start of caplacizumab treatment initiation
* Patient has a diagnosis of iTTP documented in the medical records
* Patient was treated with caplacizumab within the eligibility period

Exclusion Criteria

* Patient declined use of data for study (where local regulations require patient notification of planned study)
* Patient's medical chart is missing or not retrievable

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Sciences and Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

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Sanofi-Aventis

Chilly-Mazarin, , France

Site Status

Countries

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France

Other Identifiers

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OBS17325

Identifier Type: -

Identifier Source: org_study_id