NCT05263193

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

Retrospective Data Collection of Pediatric Patients With Immune-mediated Thrombotic Thrombocytopenic Purpura (iTTP) Treated With Caplacizumab

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 4 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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

• Immune-mediated Thrombocytopenic Purpura

Interventions

Type	Name	Description
DRUG	Caplacizumab	as in real world practice

Timeline

• Start date: 2022-06-08
• Primary completion: 2022-10-28
• Completion: 2022-10-28
• First posted: 2022-03-02
• Last updated: 2022-12-14

Locations

1 site across 1 country: France

Regulatory

• FDA-regulated drug study