A Post-authorization Study to Describe the Safety and Efficacy of Emapalumab for the Treatment of pHLH in Treatment Experienced Chinese Patients
← catalyst calendarSponsored by Swedish Orphan Biovitrum (industry) · SOBI.ST — their whole pipeline →.
Phase
Phase 4
Status
Completed
Study type
Interventional
Design
Na · None · Treatment
Enrollment
13actual
Sites
7
Country
China
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2023-02-03 | actual | When the study began enrolling |
| Primary completion | 2025-02-21 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2025-08-08 | actual | The whole study's end, after follow-up |
| First posted | 2023-02-24 | actual | When this record first appeared on the registry |
| Results posted | 2026-03-13 | actual | When the sponsor posted results to the registry |
| Record updated | 2026-03-13 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Primary Hemophagocytic Lymphohistiocytosis
Intervention
- Drug: Emapalumab-Lzsg 5 MG/ML [Gamifant] — also filed as Gamifant
Primary outcome
what the primary-completion date above is the date OFPermanent Discontinuation of Study Drug Due to Emapalumab-related Adverse Event
measured Until conditioning for hematopoietic stem cell transplant (HSCT), likely within 6 months from first dose
Posted documents
hosted by the registry — we link, never re-serveStudy Protocolposted 2022-06-01 · 885 KB · Prot_000.pdf
Statistical Analysis Planposted 2025-08-06 · 497 KB · SAP_001.pdf
Permalink · SOBI.ST's whole pipeline · Catalyst calendar · Every registered study · What changed