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

Sanofi

Status: Completed

Conditions: Immune-mediated Thrombocytopenic Purpura

Treatments: Drug: Caplacizumab

Study type: Observational

Funder types: Industry

Identifiers

NCT05263193

OBS17325

Details and patient eligibility

About

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.

Full description

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 .

Enrollment: 4 patients

Sex: All

Ages: Under 18 years old

Volunteers: No Healthy Volunteers

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