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RHB-105 · 2 trials · 2 indications
Eradication of H. pylori confirmed via 13C Urea Breath Test (UBT) testing. Subjects with negative test results (eradication of H. pylori) were considered treatment successes. Subjects who tested positive for H. pylori infection (no eradication) were considered treatment failures.
Modified intent-to-treat (mITT) population analyzed included all participants whok received at least 1 dose of study drug and underwent a 13C Urea Breath Test (UBT) at Visit 4. Participants with negative test results were to be considered treatment successes. Patients who tested positive for H. pylori infection, and those with indeterminate, not assessable, or missing results were to be considered treatment failures. The statistical hypothesis that the active treatment is superior to 70% was to be tested against the alternative hypothesis that the active treatment is statistically indistinguishable or less than 70% effective using a one-sample Z-test.
| Arm | Type | Description |
|---|---|---|
| RHB-105 | EXPERIMENTAL | RHB-105 is an 'all-in-one' combination oral capsule consisting of combination therapy of Amoxicillin, Omeprazole and Rifabutin; as well as separate Riboflavin |
| Active Comparator | ACTIVE_COMPARATOR | Active comparator is an 'all-in-one' combination oral capsule consisting of combination therapy of Amoxicillin and Omeprazole; as well as separate Riboflavin |
| Placebo | PLACEBO_COMPARATOR | Capsules that look like the RHB-105 product but contain no active ingredient. |
| Name | Type | Description |
|---|---|---|
| RHB-105 | DRUG | The intended dose of RHB-105 (12.5 mg rifabutin, 250 mg amoxicillin, and 10 mg omeprazole capsules) 4 capsules every eight hours, is equivalent to a total daily dose of: * Rifabutin 150 mg * Amoxicillin 3000 mg * Omeprazole 120 mg One 50mg Riboflavin tablet to be taken once daily to maintain the blind. |
| Active Comparator | DRUG | The intended dose of the Active Comparator (250 mg amoxicillin, and 10 mg omeprazole capsules) 4 capsules every eight hours, equivalent to a total daily dose of: * Amoxicillin 3000 mg * Omeprazole 120 mg One 50mg Riboflavin tablet to be taken once daily to maintain the blind. |
| Placebo | DRUG | Subjects will take 4 placebo capsules every 8 hours with food for 14 days. |
Inclusion Criteria: 1. Be ages 18 - 70, inclusive; non-Asian males and females (This population has been demonstrated to have significantly elevated omeprazole levels as per the prescriber information for other omeprazole products). A person having origins in any of the original peoples of the Far ...
RHB-105 is an investigational small molecule being developed for the treatment of Helicobacter pylori infection and dyspepsia. It is a combination therapy designed to eradicate H. pylori, a bacterium associated with gastrointestinal conditions. RHB-105 is currently in Phase 3 clinical development and is not yet approved by regulatory authorities.
RHB-105 targets Helicobacter pylori, a bacterium that infects the stomach lining and can cause dyspepsia and other gastrointestinal disorders. The drug is designed to eradicate this infection, which is a key factor in the development of related conditions. Its mechanism involves a combination of active agents that work against the bacterium.
RHB-105 is being developed by Redhill Biopharma Ltd., a biopharmaceutical company listed on the stock exchange under the ticker RDHL. The company is conducting clinical trials to evaluate the safety and efficacy of RHB-105 for the treatment of Helicobacter pylori infection and associated dyspepsia.
RHB-105 is in Phase 3 clinical development. It has completed two Phase 3 trials, including the ERADICATE Hp and ERADICATE Hp2 studies. These trials were randomized, double-blind, and placebo-controlled, with the second trial also comparing RHB-105 to an active comparator. RHB-105 remains investigational and is not yet approved.
RHB-105 has been studied in two completed Phase 3 clinical trials. The first, NCT01980095, enrolled 119 participants with dyspepsia and H. pylori infection. The second, NCT03198507, enrolled 455 participants and compared RHB-105 to an active comparator. Both trials were conducted in the United States with adult participants.
RHB-105 is a distinct investigational drug developed by Redhill Biopharma. It is a combination therapy specifically formulated to treat Helicobacter pylori infection. While it may share similarities with existing treatments, RHB-105 is being evaluated as a novel option in Phase 3 trials, and no alternative names have been associated with it.