Comparison · NCT03759665-sae
Treatment With IB1001 vs Post-Treatment Washout: serious adverse events
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. Treatment With IB1001 vs Post-Treatment Washout: serious adverse events. Trial comparisons, record NCT03759665-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03759665-sae
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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 | 0.0667 | 0.0185 | 0.213 | wilson | |
| Risk in group 2 | 0 | 0 | 0.114 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0667 | -0.0567 | 0.213 | 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 harm, for one more participant with a serious adverse event on Treatment With IB1001 than on Post-Treatment Washout | 15 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Treatment With IB1001 | Parent Study: 6-weeks treatment with IB1001 administered orally. Patients ≥13 years old in Europe and ≥18 years old in the United States received a total daily dose of 4 g/day (administered as 3 doses per day).~Patients 6-12 years old received weight-tiered doses:~* Patients aged 6-12 years weighing 15 to \<25 kg took 2 g per day: 1g in the morning and 1 g in the evening.~* Patients aged 6-12 years weighing 25 to \<35 kg took 3 g per day: 1g in the morning, 1 g in the afternoon, and 1 g in the evening.~* Patients aged 6-12 years weighing ≥35 kg took 4 g per day: 2g in the morning, 1 g in the afternoon and 1g in the evening (as per adults)~IB1001: IB1001 (N-Acetyl-L-Leucine) is a modified amino-acid ester that is orally administered. | 2 | 30 | EG000 |
| Group 2 | Post-Treatment Washout | After the Parent Study 6-week treatment period, patients entered a 6-week post-treatment washout period. | 0 | 30 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- From signing of the informed consent form through to End of Study (Day 84, scheduled at 42 days post last IB1001dose).
Source ClinicalTrials.gov
Trial
- Title
- N-Acetyl-L-Leucine for GM2 Gangliosidosis (Tay-Sachs and Sandhoff Disease)
- NCT number
- NCT03759665
- Phases
- PHASE2
- Conditions
- GM2 Gangliosidosis, Tay-Sachs Disease, Sandhoff Disease
- Interventions
- IB1001
- Lead sponsor
- IntraBio Inc
- Results first posted
- 2024-03-12
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03759665?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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