A Non-interventional, Post-Marketing Study to Describe Outcome of Nitisinone Treatment in HT-1 Patients
← catalyst calendarNCT06227429 · readout in 315 d
Sponsored by Swedish Orphan Biovitrum (industry) · SOBI.ST — their whole pipeline →.
Phase
—
Status
Withdrawn
Study type
Observational
Enrollment
0actual
Sites
4
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
Why the sponsor stopped it
No patients were prescribed to the study treatment due to the generic treatment being available.
As filed on the registry record, in the sponsor's own words.
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | Sep 2025 | estimated | When the study began enrolling |
| Primary completion | 2027-06-30 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2027-06-30 | estimated | The whole study's end, after follow-up |
| First posted | 2024-01-26 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2025-12-23 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Hereditary Tyrosinemia, Type I
Intervention
- Drug: Nitisinone — also filed as Orfadin®
Primary outcome
what the primary-completion date above is the date OFOccurrence of hepatic, renal or hematological adverse events (AEs) or death
measured Data will be collected for all routine visits completed during the study period which is at least 12 months but no more than 3.5 years.
Permalink · SOBI.ST's whole pipeline · Catalyst calendar · Every registered study · What changed