NCT05744063

A Post-authorization Study to Describe the Safety and Efficacy of Emapalumab for the Treatment of pHLH in Treatment Experienced Chinese Patients

An Open Label, Single Arm, Multi-Centre, Post-authorization Study to Describe the Safety and Efficacy of Emapalumab for the Treatment of Primary Hemophagocytic Lymphohistiocytosis in Treatment Experienced Chinese Patients

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Swedish Orphan Biovitrum · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

The goal of this post-authorization study is to describe safety and efficacy of emapalumab in treatment experienced Chinese patients with pHLH.

Detailed description

This is an open-label, multi center, single arm, post-authorization study aiming to describe safety and efficacy of emapalumab in treatment experienced Chinese patients with confirmed or suspected primary hemophagocytic lymphohistiocytosis (pHLH). The main objectives of the study are to collect safety and efficacy data on emapalumab in treatment experienced Chinese pHLH patients

Conditions

• Primary Hemophagocytic Lymphohistiocytosis

Interventions

Type	Name	Description
DRUG	Emapalumab-Lzsg 5 MG/ML [Gamifant]	iv

Timeline

• Start date: 2023-02-03
• Primary completion: 2025-02-21
• Completion: 2025-08-08
• First posted: 2023-02-24
• Last updated: 2026-03-13
• Results posted: 2026-03-13

Locations

7 sites across 1 country: China