Comparison · NCT03591575-5fdeba7f
Deferiprone vs Placebo: The Percentage of Patients in Each Treatment Group Who Still Have a Serum Ferritin Level < 1000 Micrograms Per Liter (μg/L) at Month 12
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. Deferiprone vs Placebo: The Percentage of Patients in Each Treatment Group Who Still Have a Serum Ferritin Level < 1000 Micrograms Per Liter (μg/L) at Month 12. Trial comparisons, record NCT03591575-5fdeba7f. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03591575-5fdeba7f
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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 | 0.656 | 0.483 | 0.796 | wilson | |
| Risk in group 2 | 0.375 | 0.229 | 0.547 | wilson | |
| Risk difference, group 1 minus group 2 | 0.281 | 0.0369 | 0.483 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.75 | 1.05 | 2.92 | log | |
| Odds ratio, group 1 over group 2 | 3.18 | 1.15 | 8.84 | log | |
| Number needed to treat, for one more participant with the outcome on Deferiprone than on Placebo | 3.56 | 2.07 | 27.1 | 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 | Deferiprone | Subjects in this group will receive deferiprone oral solution at a dosage up to 75 milligrams per kilogram of body weight (mg/kg) per day, divided into 3 equal doses~Deferiprone oral solution: Liquid formulation of deferiprone, with a concentration of 80 mg/mL | 21 | 32 | OG000 |
| Group 2 | Placebo | Subjects in this group will receive placebo solution at a volume equal to what they would receive if they were in the active arm, divided into 3 equal doses~Placebo: Liquid solution that matches deferiprone oral solution in appearance and taste | 12 | 32 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- The Percentage of Patients in Each Treatment Group Who Still Have a Serum Ferritin Level < 1000 Micrograms Per Liter (μg/L) at Month 12
- Description
Current treatment guidelines are that standard iron chelation therapy should begin after a serum ferritin level of 1000 μg/L has been reached; thus, patients who were at this level at two consecutive visits were removed from the study so that they could start on this therapy.
- Time frame
- 12 months
- Population
- Intent-to-Treat (ITT) population. For patients who withdrew early, imputed data were used to estimate the serum ferritin values that would likely have been seen at Month 12 had they continued.
Source ClinicalTrials.gov
Trial
- Title
- Safety and Efficacy of Early Treatment With Deferiprone in Infants and Young Children
- NCT number
- NCT03591575
- Phases
- PHASE4
- Conditions
- Beta Thalassemia Major Anemia, Iron Overload
- Interventions
- Deferiprone oral solution, Placebo
- Lead sponsor
- Chiesi Canada Corp
- Results first posted
- 2024-03-15
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03591575?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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