Trial · NCT04251026
A Study of Tividenofusp Alfa (DNL310) in Pediatric Participants With Hunter Syndrome
NCT04251026, Phase 1, Phase 2, Active not recruiting, Denali Therapeutics Inc.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study of Tividenofusp Alfa (DNL310) in Pediatric Participants With Hunter Syndrome. Trials, record NCT04251026. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04251026
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Tividenofusp Alfa (DNL310) in Pediatric Participants With Hunter Syndrome
- NCT number
- NCT04251026
- Status
- Active not recruiting
- Phases
- Phase 1, Phase 2
- Enrollment
- 47 participants, actual
- Lead sponsor
- Denali Therapeutics Inc.
- Conditions
- Mucopolysaccharidosis II
- Interventions
- tividenofusp alfa
- First posted
- 2020-01-31
- Last updated
- 2025-08-07
- Other registries' IDs
- eudract:2019-004909-27
Source ClinicalTrials.gov
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence and severity of treatment-emergent adverse events (TEAEs) | 24 weeks, 104 weeks, and 357 weeks | |
| Primary | Change from baseline in urine total glycosaminoglycan (GAG) concentrations | 24 weeks, 104 weeks, and 357 weeks | |
| Primary | Incidence and severity of infusion-related reactions (IRRs) | 24 weeks, 104 weeks, and 357 weeks | |
| Primary | Change from baseline in concomitant medications | 24 weeks, 104 weeks, and 357 weeks | |
| Secondary | Percentage change from baseline in cerebrospinal fluid (CSF) of heparan sulfate | 24 weeks | |
| Secondary | Participants with improvement in individual disease progression in the Vineland Adaptive Behavior Scale Adaptive Behavior Composite (ABC) score | 49 weeks | |
| Secondary | Participants with improvement in individual disease progression in the Vineland Adaptive Behavior Scale subdomain scores | 49 weeks | |
| Secondary | PK parameter: Maximum observed concentration (Cmax) of DNL310 in serum | 24 weeks | |
| Secondary | PK parameter: Trough concentration (Cmin) of DNL310 in serum | 24 weeks | |
| Secondary | PK parameter: Time to maximum observed concentration (tmax) of DNL310 in serum | 24 weeks |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 41467650 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04251026
GET https://conductscience.org/api/trials/v1/NCT04251026/registered