Comparison · NCT01774487-bd2a8abf
Pentoxifylline - Group 1 vs Pentoxifylline - Group 2: Number of Participants With Normal Serum Conjugated Bilirubin Levels 12 Weeks After Starting PTX (Pentoxifylline) Therapy
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. Pentoxifylline - Group 1 vs Pentoxifylline - Group 2: Number of Participants With Normal Serum Conjugated Bilirubin Levels 12 Weeks After Starting PTX (Pentoxifylline) Therapy. Trial comparisons, record NCT01774487-bd2a8abf. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01774487-bd2a8abf
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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 | 0.75 | 0.409 | 0.929 | wilson | |
| Risk in group 2 | 0 | 0 | 0.793 | wilson | |
| Risk difference, group 1 minus group 2 | 0.75 | -0.114 | 0.929 | 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 Pentoxifylline - Group 1 than on Pentoxifylline - Group 2 | 1.33 | 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 | Pentoxifylline - Group 1 | Infants receiving the Kasai portoenterostomy (KP) will be given PTX for 12 weeks, and the number whose CB levels return to normal (0.0-0.3 mg/dL) will be calculated. Historically, \~60% of such infants have normal CB levels after 12 weeks. The study will determine whether PTX improves this percentage. | 6 | 8 | OG000 |
| Group 2 | Pentoxifylline - Group 2 | For Group 2: Infants not receiving the KP will be given PTX for 12 weeks, and the number whose CB levels stabilize (within 10% of starting level) will be calculated. Historically, \~10% of such infants have stable CB levels after 12 weeks. The study will determine whether PTX improves this percentage. | 0 | 1 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Number of Participants With Normal Serum Conjugated Bilirubin Levels 12 Weeks After Starting PTX (Pentoxifylline) Therapy
- Description
The investigators will track the serum conjugated bilirubin (CB) levels over the course of therapy in patients receiving 90 days of PTX (this laboratory test is drawn as part of routine care). Normal CB is 0.0-0.3 mg/dL, with a higher number of patients meeting this indicating a better outcome.
- Time frame
- 12 weeks after starting therapy
- Population
Source ClinicalTrials.gov
Trial
- Title
- Pentoxifylline Therapy in Biliary Atresia
- NCT number
- NCT01774487
- Phases
- PHASE2
- Conditions
- Biliary Atresia
- Interventions
- Pentoxifylline
- Lead sponsor
- Baylor College of Medicine
- Results first posted
- 2023-10-12
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01774487?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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