Comparison · NCT03198507-ac1bd0ac
RHB-105 vs Active Comparator: Number of Participants With Eradication of H. Pylori in the Pharmacokinetic Population (PKP)
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. RHB-105 vs Active Comparator: Number of Participants With Eradication of H. Pylori in the Pharmacokinetic Population (PKP). Trial comparisons, record NCT03198507-ac1bd0ac. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03198507-ac1bd0ac
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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 | 0.903 | 0.855 | 0.937 | wilson | |
| Risk in group 2 | 0.647 | 0.575 | 0.712 | wilson | |
| Risk difference, group 1 minus group 2 | 0.257 | 0.176 | 0.335 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.4 | 1.24 | 1.57 | log | |
| Odds ratio, group 1 over group 2 | 5.11 | 2.94 | 8.86 | log | |
| Number needed to treat, for one more participant with the outcome on RHB-105 than on Active Comparator | 3.9 | 2.98 | 5.7 | from the risk difference interval |
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 | RHB-105 | RHB-105 (Rifabutin 150 mg, Amoxicillin 3000 mg, Omeprazole 120 mg) | 187 | 207 | OG000 |
| Group 2 | Active Comparator | Active comparator (Amoxicillin 3000 mg, Omeprazole 120 mg) | 119 | 184 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- OTHER_PRE_SPECIFIED
- Title
- Number of Participants With Eradication of H. Pylori in the Pharmacokinetic Population (PKP)
- Description
A pre-specified responder analysis of eradication of H. pylori confirmed via 13C Urea Breath Test (UBT) was performed in the PK population.~The PK population was generated based on the measurement of plasma concentrations of amoxicillin, omeprazole, rifabutin, and the rifabutin metabolite 25-O-desacetyl-rifabutin (on Day 13). It included those subjects in the FAS who had demonstrable presence of any component of investigational drug at Visit 3 or had no levels detected \>250 hours after the last dose. For all subjects, the reason for exclusion from the PKP was the absence of any pharmacokinetic component of study drug at Visit 3 within 250 hours of the last reported dose. Two hundred fifty hours was selected to account for approximately 10 times the terminal half-life of rifabutin.
- Time frame
- 43-71 days after initiation of treatment
- Population
- Pharmacokinetic Population (PKP)
Source ClinicalTrials.gov
Trial
- Title
- ERADICATE Hp2 - Treating Helicobacter Pylori With RHB-105 Compared to Active Comparator
- NCT number
- NCT03198507
- Phases
- PHASE3
- Conditions
- Helicobacter Pylori Infection, Dyspepsia
- Interventions
- RHB-105, Active Comparator
- Lead sponsor
- RedHill Biopharma Limited
- Results first posted
- 2020-03-16
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03198507?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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