A Study of Tividenofusp Alfa (DNL310) in Pediatric Participants With Hunter Syndrome
← catalyst calendarNCT04251026 · readout ≤ 1,654 d
Sponsored by Denali Therapeutics Inc. (industry) · DNLI — their whole pipeline →.
Phase
Phase 1/2
Status
Active, not recruiting
Study type
Interventional
Design
Non randomized · None · Treatment
Enrollment
47actual
Sites
7
Countries
Canada, Netherlands, United Kingdom +1
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 | 2020-07-16 | actual | When the study began enrolling |
| Primary completion | Feb 2031 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Feb 2031 | estimated | The whole study's end, after follow-up |
| First posted | 2020-01-31 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2025-08-07 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Mucopolysaccharidosis II
Intervention
- Drug: tividenofusp alfa
Primary outcomes
what the primary-completion date above is the date OFIncidence and severity of treatment-emergent adverse events (TEAEs)
measured 24 weeks, 104 weeks, and 357 weeks
Change from baseline in urine total glycosaminoglycan (GAG) concentrations
measured 24 weeks, 104 weeks, and 357 weeks
Incidence and severity of infusion-related reactions (IRRs)
measured 24 weeks, 104 weeks, and 357 weeks
Change from baseline in concomitant medications
measured 24 weeks, 104 weeks, and 357 weeks
Publications
- PMID 41467650 — linked by the registry
Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.
Permalink · DNLI's whole pipeline · Catalyst calendar · Every registered study · What changed