Trial Outcomes & Findings for ERADICATE Hp - Treating Helicobacter Pylori With RHB-105 (NCT NCT01980095)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

119 participants

Primary outcome timeframe

28-56 days after completion of treatment

Results posted on

2019-09-24

Participant Flow

Participant milestones

Participant milestones
Measure	RHB-105 RHB-105 is an 'all-in-one' combination oral capsule consisting of 2 different antibiotics and a proton pump inhibitor combined in a single capsule. Total daily dose of: Rifabutin 150 mg, Amoxicillin 3000 mg and Omeprazole 120 mg	Placebo Capsules that look like the RHB-105 product but contain no active ingredient.
Overall Study STARTED	78	41
Overall Study Treated	77	41
Overall Study COMPLETED	63	30
Overall Study NOT COMPLETED	15	11

Reasons for withdrawal

Reasons for withdrawal
Measure	RHB-105 RHB-105 is an 'all-in-one' combination oral capsule consisting of 2 different antibiotics and a proton pump inhibitor combined in a single capsule. Total daily dose of: Rifabutin 150 mg, Amoxicillin 3000 mg and Omeprazole 120 mg	Placebo Capsules that look like the RHB-105 product but contain no active ingredient.
Overall Study Lost to Follow-up	6	7
Overall Study Withdrawal by Subject	2	3
Overall Study Poor compliance	5	0
Overall Study Safety issue	0	1
Overall Study Study drug discontinued	1	0
Overall Study Randomized by mistake	1	0

Baseline Characteristics

ERADICATE Hp - Treating Helicobacter Pylori With RHB-105

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	RHB-105 n=77 Participants RHB-105 is an 'all-in-one' combination oral capsule consisting of 2 different antibiotics and a proton pump inhibitor combined in a single capsule. Total daily dose of: Rifabutin 150 mg, Amoxicillin 3000 mg and Omeprazole 120 mg.	Placebo n=41 Participants Capsules that look like the RHB-105 product but contain no active ingredient.	Total n=118 Participants Total of all reporting groups
Age, Continuous	46.2 years STANDARD_DEVIATION 10.56 • n=5 Participants	45.8 years STANDARD_DEVIATION 9.52 • n=7 Participants	46 years STANDARD_DEVIATION 10.18 • n=5 Participants
Sex: Female, Male Female	28 Participants n=5 Participants	16 Participants n=7 Participants	44 Participants n=5 Participants
Sex: Female, Male Male	49 Participants n=5 Participants	25 Participants n=7 Participants	74 Participants n=5 Participants

PRIMARY outcome

Timeframe: 28-56 days after completion of treatment

Population: The mITT Population included all subjects who received at least 1 dose of randomized study treatment and underwent a 13C UBT test at Visit 4. This population consisted in 66 subjects in the RHB-105 group and 37 subjects in the placebo group.

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.

Outcome measures

Outcome measures
Measure	RHB-105 n=66 Participants RHB-105 is an 'all-in-one' combination oral capsule consisting of 2 different antibiotics and a proton pump inhibitor combined in a single capsule. Total daily dose of: * Rifabutin 150 mg * Amoxicillin 3000 mg * Omeprazole 120 mg	Placebo n=37 Participants Capsules that look like the RHB-105 product but contain no active ingredient. Placebo: Subjects will take 4 placebo capsules every 8 hours with food for 14 days.
The Occurrence of H. Pylori Eradication as Confirmed Via 13C UBT Testing H. pylori eradication success	59 Participants	1 Participants
The Occurrence of H. Pylori Eradication as Confirmed Via 13C UBT Testing H. pylori eradication failure	7 Participants	36 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 28-56 days after completion of SOC treatment

Population: Eradication Failure Subjects at Visit 4 were treated with standard of care therapy by the investigator and performed a 13C Urea Breath Test at Visit 8 to confirm H. pylori eradication. This population included 27 subjects in the placebo group and 4 subjects in the active drug eradication failure subjects.

The occurrence of H. pylori eradication in Placebo and Active Drug Eradication Failure Patients treated with Standard of Care (SOC) treatment

Outcome measures

Outcome measures
Measure	RHB-105 n=27 Participants RHB-105 is an 'all-in-one' combination oral capsule consisting of 2 different antibiotics and a proton pump inhibitor combined in a single capsule. Total daily dose of: * Rifabutin 150 mg * Amoxicillin 3000 mg * Omeprazole 120 mg	Placebo n=4 Participants Capsules that look like the RHB-105 product but contain no active ingredient. Placebo: Subjects will take 4 placebo capsules every 8 hours with food for 14 days.
H. Pylori Eradication H. pylori eradication success	17 Participants	2 Participants
H. Pylori Eradication H. pylori eradication failure	10 Participants	2 Participants

Adverse Events

RHB-105

Serious events: 1 serious events

Other events: 38 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 17 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	RHB-105 n=77 participants at risk RHB-105 is an 'all-in-one' combination oral capsule consisting of 2 different antibiotics and a proton pump inhibitor combined in a single capsule. Total daily dose of: Rifabutin 150 mg, Amoxicillin 3000 mg and Omeprazole 120 mg.	Placebo n=41 participants at risk Identical capsules that look like the RHB-105 product but contain no active ingredient.
Blood and lymphatic system disorders Anemia of Grade 3	1.3% 1/77 • Number of events 1 • 1 year and 10 months	0.00% 0/41 • 1 year and 10 months
Skin and subcutaneous tissue disorders Perirectal Abscess	0.00% 0/77 • 1 year and 10 months	2.4% 1/41 • Number of events 1 • 1 year and 10 months

Other adverse events

Other adverse events
Measure	RHB-105 n=77 participants at risk RHB-105 is an 'all-in-one' combination oral capsule consisting of 2 different antibiotics and a proton pump inhibitor combined in a single capsule. Total daily dose of: Rifabutin 150 mg, Amoxicillin 3000 mg and Omeprazole 120 mg.	Placebo n=41 participants at risk Identical capsules that look like the RHB-105 product but contain no active ingredient.
Gastrointestinal disorders Diarrhoea	14.3% 11/77 • Number of events 14 • 1 year and 10 months	9.8% 4/41 • Number of events 4 • 1 year and 10 months
Gastrointestinal disorders Abdominal tenderness	6.5% 5/77 • Number of events 5 • 1 year and 10 months	7.3% 3/41 • Number of events 3 • 1 year and 10 months
Gastrointestinal disorders Flatulence	2.6% 2/77 • Number of events 2 • 1 year and 10 months	7.3% 3/41 • Number of events 3 • 1 year and 10 months
Nervous system disorders Headache	13.0% 10/77 • Number of events 13 • 1 year and 10 months	9.8% 4/41 • Number of events 4 • 1 year and 10 months
Nervous system disorders Dizziness	3.9% 3/77 • Number of events 4 • 1 year and 10 months	7.3% 3/41 • Number of events 3 • 1 year and 10 months
Renal and urinary disorders Chromaturia	13.0% 10/77 • Number of events 10 • 1 year and 10 months	2.4% 1/41 • Number of events 1 • 1 year and 10 months

Additional Information

Dr. Ira Kalfus

RedHill Biopharma

Phone: 1-917-817-7517

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The PI agree that the Sponsor shall have the right to the first publication of the results of the Study. Following the first publication, the PI may publish data or results from the Study; subject to Sponsor for review and approval in writing at least sixty (60) days prior to the date of the publication. Sponsor may require changes and may extend the embargo to protect its intellectual property or other proprietary interests and to allow for the taking actions for this purpose.
Publication restrictions are in place

Restriction type: OTHER