Trial · NCT03198507

ERADICATE Hp2 - Treating Helicobacter Pylori With RHB-105 Compared to Active Comparator

NCT03198507, Phase 3, Completed, RedHill Biopharma Limited; results first posted 2020-03-16

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. ERADICATE Hp2 - Treating Helicobacter Pylori With RHB-105 Compared to Active Comparator. Trials, record NCT03198507. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03198507

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: ERADICATE Hp2 - Treating Helicobacter Pylori With RHB-105 Compared to Active Comparator
NCT number: NCT03198507
Status: Completed
Phases: Phase 3
Enrollment: 455 participants, actual
Lead sponsor: RedHill Biopharma Limited
Conditions: Helicobacter Pylori Infection, Dyspepsia
Interventions: RHB-105, Active Comparator
First posted: 2017-06-26
Last updated: 2020-03-16
Results first posted: 2020-03-16

Source ClinicalTrials.gov

Registered outcomes4

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Number of Participants With Eradication of H. Pylori	43-71 days after initiation of treatment	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.
Secondary	Number of Participants With H. Pylori Cultures That Presented Antibiotic Resistance and Susceptibility	43-71 days after initiation of treatment	The primary endpoint was summarized within subgroups formed by the presence of H. pylori susceptibility and resistance to amoxicillin, clarithromycin, metronidazole, and rifabutin from H. pylori cultures from samples obtained prior to initiating study treatment (i.e. baseline). A participant is considered a responder when H. pylori is eradicated after treatment as confirmed via 13C Urea Breath Test (UBT). A participant is considered a non-responder when H. pylori is not eradicated after treatment.
Secondary	Number of Participants With Adverse Events That Are Related to Treatment	After first dose of study drug until 28 days following last dose.	The number of participants that presented treatment emergent adverse events (TEAE) during the study overall, TEAEs related to study drug and severe TEAEs.
Other	Number of Participants With Eradication of H. Pylori in the Pharmacokinetic Population (PKP)	43-71 days after initiation of treatment	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.

Source ClinicalTrials.gov

Outcomes4

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Participants With Eradication of H. Pylori	43-71 days after initiation of treatment	Full Analysis Set (FAS)	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants With H. Pylori Cultures That Presented Antibiotic Resistance and Susceptibility	43-71 days after initiation of treatment	n is the number of cultures obtained from the in the FAS population in each treatment group with H. pylori resistant/susceptible to Rifabutin, Amoxicillin, Clarithromycin or Metronidazole at baseline	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants With Adverse Events That Are Related to Treatment	After first dose of study drug until 28 days following last dose.	Safety Population	Participants	COUNT_OF_PARTICIPANTS
OTHER_PRE_SPECIFIED	Number of Participants With Eradication of H. Pylori in the Pharmacokinetic Population (PKP)	43-71 days after initiation of treatment	Pharmacokinetic Population (PKP)	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group42

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
Number of Participants With Eradication of H. Pylori	RHB-105		191	Participants
Number of Participants With Eradication of H. Pylori	Active Comparator		131	Participants
Number of Participants With H. Pylori Cultures That Presented Antibiotic Resistance and Susceptibility	RHB-105	Rifabutin resistant / Responder	0	Participants
Number of Participants With H. Pylori Cultures That Presented Antibiotic Resistance and Susceptibility	Active Comparator	Rifabutin resistant / Responder	0	Participants
Number of Participants With H. Pylori Cultures That Presented Antibiotic Resistance and Susceptibility	RHB-105	Rifabutin resistant / Non-responder	0	Participants
Number of Participants With H. Pylori Cultures That Presented Antibiotic Resistance and Susceptibility	Active Comparator	Rifabutin resistant / Non-responder	0	Participants
Number of Participants With H. Pylori Cultures That Presented Antibiotic Resistance and Susceptibility	RHB-105	Rifabutin Susceptible / Responder	147	Participants
Number of Participants With H. Pylori Cultures That Presented Antibiotic Resistance and Susceptibility	Active Comparator	Rifabutin Susceptible / Responder	99	Participants
Number of Participants With H. Pylori Cultures That Presented Antibiotic Resistance and Susceptibility	RHB-105	Rifabutin Susceptible / Non-responder	27	Participants
Number of Participants With H. Pylori Cultures That Presented Antibiotic Resistance and Susceptibility	Active Comparator	Rifabutin Susceptible / Non-responder	72	Participants

1 to 10 of 42Source ClinicalTrials.gov

See all 42 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	RHB-105	228
Overall Study	STARTED	Active Comparator	227
Overall Study	COMPLETED	RHB-105	227
Overall Study	COMPLETED	Active Comparator	227
Overall Study	NOT COMPLETED	RHB-105	1
Overall Study	NOT COMPLETED	Active Comparator	0

Source ClinicalTrials.gov

Adverse events10

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Diarrhoea	Gastrointestinal disorders	RHB-105	23	228	23
other	Diarrhoea	Gastrointestinal disorders	Active Comparator	18	227	18
other	Nausea	Gastrointestinal disorders	RHB-105	11	228	11
other	Nausea	Gastrointestinal disorders	Active Comparator	12	227	12
other	Headache	Nervous system disorders	RHB-105	17	228	17
other	Headache	Nervous system disorders	Active Comparator	16	227	16
serious	Diabetic ketoacidosis	Metabolism and nutrition disorders	RHB-105	1	228	1
serious	Diabetic ketoacidosis	Metabolism and nutrition disorders	Active Comparator	0	227	0
serious	Acute Encephalopathy	Nervous system disorders	RHB-105	0	228	0
serious	Acute Encephalopathy	Nervous system disorders	Active Comparator	1	227	1

Source ClinicalTrials.gov

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	RHB-105	0	228
Total, all-cause mortality	Active Comparator	0	227
Total, other adverse events	RHB-105	51	228
Total, other adverse events	Active Comparator	46	227
Total, serious adverse events	RHB-105	1	228
Total, serious adverse events	Active Comparator	1	227

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
32365359	DERIVED	PubMed
34862940	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons4

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
RHB-105 vs Active Comparator: Number of Participants With Eradication of H. Pylori	Trial comparisons
RHB-105 vs Active Comparator: Number of Participants With Eradication of H. Pylori in the Pharmacokinetic Population (PKP)	Trial comparisons
RHB-105 vs Active Comparator: deaths from any cause	Trial comparisons
RHB-105 vs Active Comparator: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

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
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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