Trial · NCT05345171
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Plasma Ammonia as Measured by 24-Hour Ammonia (AUC0-24) | Week 36 | |
| Primary | Complete Responder Rate at the Final Study Visit After DTX301 Exposure | Up to 64 Weeks Post DTX301 Infusion | |
| Secondary | Percentage of Complete Responders or Responders After DTX301 Exposure | Up to 64 Weeks Post DTX301 Infusion | |
| Secondary | Annualized Event Rate of Hyperammonemic Crises (HACs) Pre-DTX301 Exposure vs Post-DTX301 Exposure | Pre-enrollment, Baseline, Up to 64 Weeks Post DTX301 Infusion | |
| Secondary | Annualized Event Rate of Interim Clinical Events (ICEs) Pre-DTX301 Exposure vs Post-DTX301 Exposure | Pre-enrollment, Baseline, Up to 64 Weeks Post DTX301 Infusion | |
| Secondary | Change from Baseline in Plasma Ammonia (AUC0-24) | Baseline, Up to Week 36 | |
| Secondary | Change in Plasma Ammonia (AUC0-24) After DTX301 Exposure | Up to 64 Weeks Post DTX301 Infusion | |
| Secondary | Percentage of Participants Who Have Achieved Complete Management Response (CMR) or Management Response (MR) After DTX301 Exposure | Up to 64 Weeks Post DTX301 Infusion | |
| Secondary | Change in Baseline Disease Management (Dietary Protein and Total Scavenger Medication Use) With Plasma Ammonia (AUC0-24) | Up to 64 Weeks Post DTX301 Infusion | |
| Secondary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, Related TEAEs, Related Serious TEAEs and Adverse Events of Special Interest (AESIs) | Up to Week 324 | |
| Secondary | Number of Participants With Anti-OTC Antibodies | Up to Week 324 | |
| Secondary | Long-Term Durability of Response | Up to 64 Weeks Post DTX301 Infusion | Based Upon Number of Complete Responders or Responders That Have ≥ 2 Consecutive Visits as a Complete Responder or Responder and Do Not Return to a Lower Responder Status for \> 1 Consecutive Visit |
| Secondary | Change in Plasma Ammonia (AUC0-24) for Participants Who Have an Elevated Ammonia AUC0-24 at Baseline | Baseline, Up to 64 Weeks Post DTX301 Infusion |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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 list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT05345171/registered