Comparison · NCT03729362-d28a0645
Cipaglucosidase Alfa/Miglustat vs Alglucosidase Alfa/Placebo: Number of Participants Improving on Both 6MWD and % Predicted FVC at Week 52
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. Cipaglucosidase Alfa/Miglustat vs Alglucosidase Alfa/Placebo: Number of Participants Improving on Both 6MWD and % Predicted FVC at Week 52. Trial comparisons, record NCT03729362-d28a0645. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03729362-d28a0645
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.165 | 0.101 | 0.258 | wilson | |
| Risk in group 2 | 0 | 0 | 0.0941 | wilson | |
| Risk difference, group 1 minus group 2 | 0.165 | 0.0509 | 0.258 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | log | a group has no participants with the outcome | |||
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to treat, for one more participant with the outcome on Cipaglucosidase Alfa/Miglustat than on Alglucosidase Alfa/Placebo | 6.07 | 3.88 | 19.6 | from the risk difference interval |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Cipaglucosidase Alfa/Miglustat | Cipaglucosidase alfa co-administered with miglustat every 2 weeks (Q2W) | 14 | 85 | OG000 |
| Group 2 | Alglucosidase Alfa/Placebo | Alglucosidase alfa co-administered with placebo every 2 weeks (Q2W) | 0 | 37 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants Improving on Both 6MWD and % Predicted FVC at Week 52
- Description
A composite subject-level response of the 2 relevant clinical outcomes, 6MWD and FVC (% predicted), was assessed. Prespecified thresholds were used for assessment of improvement consistent with published minimal clinically important difference values for comparable instruments in similar disease.
- Time frame
- Week 52
- Population
Analysis was performed on ITT-LOCF population. In the cipaglucosidase alfa/miglustat group, 1 subject who had no post-baseline FVC value was counted as not improved and included in the analysis. In the alglucosidase alfa/placebo group, the outlier subject was not included in the analysis.
Source ClinicalTrials.gov
Trial
- Title
- A Study Comparing ATB200/AT2221 With Alglucosidase Alfa/Placebo in Adult Subjects With Late-onset Pompe Disease
- NCT number
- NCT03729362
- Phases
- PHASE3
- Conditions
- Pompe Disease (Late-onset)
- Interventions
- Cipaglucosidase Alfa, Miglustat, Alglucosidase Alfa, Placebo
- Lead sponsor
- Amicus Therapeutics
- Results first posted
- 2023-09-11
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03729362?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
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
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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