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A Study of Tividenofusp Alfa (DNL310) in Pediatric Participants With Hunter Syndrome

StatusActive, Not Recruiting
PhasePhase 1/2
Started
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Record History

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  1. Primary and study completion dates: Jul 2027 to Feb 2031v26
  2. Re-verified, no change to tracked fieldsv25
  3. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 45 to confirmed 47
    • Site details revised at 7 of 7 sites
    v24
  4. Site contacts updated at 1 of 7 sitesv23
  5. Interventions: DNL310 (Drug) to tividenofusp alfa (Drug)
    • Site contacts updated at 2 of 7 sites
    • Study title expanded, about 2 words
    v22
Show 20 earlier versionsHide 20 earlier versions
  1. Site contacts updated at 1 of 7 sitesv21
  2. Site contacts updated at 1 of 7 sitesv20
  3. Site contacts updated at 1 of 7 sitesv19
  4. Site contacts updated at 1 of 7 sitesv18
  5. Study sites: 5 to 7
    • Eligibility criteria expanded, about 38 words
    • Secondary endpoints: details revised at 2 of 14 entries
    v17
  6. Re-verified, no change to tracked fieldsv16
  7. Site contacts updated at 1 of 5 sitesv15
  8. Site contacts updated at 1 of 5 sitesv14
  9. Enrollment target: 30 to 45v13 Show 5 more changesShow less
    • Primary and study completion dates: Mar 2024 to Jul 2027
    • Eligibility criteria expanded, about 44 words
    • Secondary endpoints: 10 to 14
    • Study sites revised (5)
    • Study arms: 3 to 5
  10. Site contacts updated at 1 of 5 sitesv12
  11. Study sites: 4 to 5v11
  12. Site contacts updated at 2 of 4 sitesv10
  13. Site contacts updated at 1 of 4 sitesv9
  14. Enrollment target: 16 to 30v8 Show 7 more changesShow less
    • Primary and study completion dates: Jan 2023 to Mar 2024
    • Primary endpoints: 2 to 4
    • Eligibility criteria expanded, about 35 words
    • Secondary endpoints: 11 to 10
    • Site contacts updated at 1 of 4 sites
    • Study title revised
    • Study arms: 2 to 3
  15. Study sites: 3 to 4v7
  16. Study sites: 2 to 3v6
  17. Re-verified, no change to tracked fieldsv5
  18. Study sites: 1 to 2v4
  19. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Jun 2020 to Jul 16, 2020
    v3
  20. Re-verified, no change to tracked fieldsv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This is a multicenter, multiregional, open-label study to assess the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of tividenofusp alfa (DNL310), an investigational central nervous system (CNS)-penetrant enzyme replacement therapy (ERT), designed to treat both the peripheral and CNS manifestations of Mucopolysaccharidosis type II (MPS II; Hunter syndrome). Participants, whose physicians feel they are deriving benefit, will have the opportunity to be reconsented into a safety extension and then an open-label extension for continued evaluation.
Trial Details
NCT Number NCT04251026
Lead Sponsor Denali Therapeutics Inc.
Conditions
(from sponsor)		 Mucopolysaccharidosis II
Related terms Mucopolysaccharidosis II, Sudden Infant Death
Enrollment 47 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov