Trial · NCT05134571
China Post-marketing Surveillance (PMS) Study of Aldurazyme®
NCT05134571, Phase 4, Completed, Genzyme, a Sanofi Company
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. China Post-marketing Surveillance (PMS) Study of Aldurazyme®. Trials, record NCT05134571. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05134571
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- China Post-marketing Surveillance (PMS) Study of Aldurazyme®
- NCT number
- NCT05134571
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 12 participants, actual
- Lead sponsor
- Genzyme, a Sanofi Company
- Conditions
- Mucopolysaccharidosis I
- Interventions
- Laronidase
- First posted
- 2021-11-26
- Last updated
- 2025-09-17
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Participants with adverse events (AEs) | Baseline to Week 27 | Incidence of AEs, serious adverse events (SAEs) and adverse events of special interest (AESIs) including infusion associated reactions (IARs) during the treatment emergent (TE) period |
| Primary | The incidence of Potentially clinically significant abnormality (PCSA) analyses for clinical laboratory, vital signs, and ECG parameters during the TE period | Baseline to Week 27 | |
| Primary | The percent change of uGAGs | Baseline to Week 26 | |
| Secondary | The percent change of uGAGs | Baseline to Week 2, Week 4, Week 8, Week 12 and Week 20 | |
| Secondary | The absolute change of uGAGs | Baseline to Week 2, Week 4, Week 8, Week 12, Week 20 and Week 26 | |
| Secondary | The percent change of liver volume (Abdominal B type ultrasound examination) | Baseline to Week 26 |
Source ClinicalTrials.gov
Outcomes0
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 |
|---|---|
| 41163043 | 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/NCT05134571
GET https://conductscience.org/api/trials/v1/NCT05134571/registered