Trial Outcomes & Findings for ERADICATE Hp2 - Treating Helicobacter Pylori With RHB-105 Compared to Active Comparator (NCT NCT03198507)
NCT ID: NCT03198507
Last Updated: 2020-03-16
Results Overview
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.
COMPLETED
PHASE3
455 participants
43-71 days after initiation of treatment
2020-03-16
Participant Flow
This study was conducted between July 2017 and December 2018. A total of 62 centers in the US screened potential subjects and 55 centers randomized subjects into the study.
Participant milestones
| Measure |
RHB-105
RHB-105 (Rifabutin 150 mg, Amoxicillin 3000 mg, Omeprazole 120 mg)
|
Active Comparator
Active comparator (Amoxicillin 3000 mg, Omeprazole 120 mg)
|
|---|---|---|
|
Overall Study
STARTED
|
228
|
227
|
|
Overall Study
COMPLETED
|
227
|
227
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
RHB-105
RHB-105 (Rifabutin 150 mg, Amoxicillin 3000 mg, Omeprazole 120 mg)
|
Active Comparator
Active comparator (Amoxicillin 3000 mg, Omeprazole 120 mg)
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
ERADICATE Hp2 - Treating Helicobacter Pylori With RHB-105 Compared to Active Comparator
Baseline characteristics by cohort
| Measure |
RHB-105
n=228 Participants
RHB-105 (Rifabutin 150 mg, Amoxicillin 3000 mg, Omeprazole 120 mg)
|
Active Comparator
n=227 Participants
Active comparator (Amoxicillin 3000 mg, Omeprazole 120 mg)
|
Total
n=455 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
214 Participants
n=5 Participants
|
207 Participants
n=7 Participants
|
421 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
14 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Age, Continuous
|
45.9 years
STANDARD_DEVIATION 12.77 • n=5 Participants
|
47.2 years
STANDARD_DEVIATION 13.13 • n=7 Participants
|
46.5 years
STANDARD_DEVIATION 12.95 • n=5 Participants
|
|
Sex: Female, Male
Female
|
132 Participants
n=5 Participants
|
151 Participants
n=7 Participants
|
283 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
96 Participants
n=5 Participants
|
76 Participants
n=7 Participants
|
172 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
149 Participants
n=5 Participants
|
124 Participants
n=7 Participants
|
273 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
79 Participants
n=5 Participants
|
103 Participants
n=7 Participants
|
182 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Black or African American
|
35 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
88 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Native Hawaiian or Other Pacific Islander
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
184 Participants
n=5 Participants
|
167 Participants
n=7 Participants
|
351 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
228 participants
n=5 Participants
|
227 participants
n=7 Participants
|
455 participants
n=5 Participants
|
|
BMI
|
30.32 Kg/m^2
STANDARD_DEVIATION 6.027 • n=5 Participants
|
30.95 Kg/m^2
STANDARD_DEVIATION 6.886 • n=7 Participants
|
30.63 Kg/m^2
STANDARD_DEVIATION 6.470 • n=5 Participants
|
PRIMARY outcome
Timeframe: 43-71 days after initiation of treatmentPopulation: Full Analysis Set (FAS)
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.
Outcome measures
| Measure |
RHB-105
n=228 Participants
RHB-105 (Rifabutin 150 mg, Amoxicillin 3000 mg, Omeprazole 120 mg)
|
Active Comparator
n=227 Participants
Active comparator (Amoxicillin 3000 mg, Omeprazole 120 mg)
|
|---|---|---|
|
Number of Participants With Eradication of H. Pylori
|
191 Participants
|
131 Participants
|
SECONDARY outcome
Timeframe: 43-71 days after initiation of treatmentPopulation: 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
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.
Outcome measures
| Measure |
RHB-105
n=174 Participants
RHB-105 (Rifabutin 150 mg, Amoxicillin 3000 mg, Omeprazole 120 mg)
|
Active Comparator
n=171 Participants
Active comparator (Amoxicillin 3000 mg, Omeprazole 120 mg)
|
|---|---|---|
|
Number of Participants With H. Pylori Cultures That Presented Antibiotic Resistance and Susceptibility
Rifabutin Susceptible · Non-responder
|
27 Participants
|
72 Participants
|
|
Number of Participants With H. Pylori Cultures That Presented Antibiotic Resistance and Susceptibility
Rifabutin resistant · Responder
|
0 Participants
|
0 Participants
|
|
Number of Participants With H. Pylori Cultures That Presented Antibiotic Resistance and Susceptibility
Rifabutin resistant · Non-responder
|
0 Participants
|
0 Participants
|
|
Number of Participants With H. Pylori Cultures That Presented Antibiotic Resistance and Susceptibility
Rifabutin Susceptible · Responder
|
147 Participants
|
99 Participants
|
|
Number of Participants With H. Pylori Cultures That Presented Antibiotic Resistance and Susceptibility
Amoxicillin Resistant · Responder
|
9 Participants
|
4 Participants
|
|
Number of Participants With H. Pylori Cultures That Presented Antibiotic Resistance and Susceptibility
Amoxicillin Resistant · Non-responder
|
4 Participants
|
5 Participants
|
|
Number of Participants With H. Pylori Cultures That Presented Antibiotic Resistance and Susceptibility
Amoxicillin Susceptible · Responder
|
138 Participants
|
95 Participants
|
|
Number of Participants With H. Pylori Cultures That Presented Antibiotic Resistance and Susceptibility
Amoxicillin Susceptible · Non-responder
|
23 Participants
|
67 Participants
|
|
Number of Participants With H. Pylori Cultures That Presented Antibiotic Resistance and Susceptibility
Clarithromycin Resistant · Responder
|
21 Participants
|
22 Participants
|
|
Number of Participants With H. Pylori Cultures That Presented Antibiotic Resistance and Susceptibility
Clarithromycin Resistant · Non-responder
|
4 Participants
|
13 Participants
|
|
Number of Participants With H. Pylori Cultures That Presented Antibiotic Resistance and Susceptibility
Clarithromycin Susceptible · Responder
|
126 Participants
|
77 Participants
|
|
Number of Participants With H. Pylori Cultures That Presented Antibiotic Resistance and Susceptibility
Clarithromycin Susceptible · Non-responder
|
23 Participants
|
59 Participants
|
|
Number of Participants With H. Pylori Cultures That Presented Antibiotic Resistance and Susceptibility
Metronidazole Resistant · Responder
|
57 Participants
|
45 Participants
|
|
Number of Participants With H. Pylori Cultures That Presented Antibiotic Resistance and Susceptibility
Metronidazole Resistant · Non-responder
|
14 Participants
|
34 Participants
|
|
Number of Participants With H. Pylori Cultures That Presented Antibiotic Resistance and Susceptibility
Metronidazole Susceptible · Responder
|
90 Participants
|
53 Participants
|
|
Number of Participants With H. Pylori Cultures That Presented Antibiotic Resistance and Susceptibility
Metronidazole Susceptible · Non-responder
|
13 Participants
|
38 Participants
|
SECONDARY outcome
Timeframe: After first dose of study drug until 28 days following last dose.Population: Safety Population
The number of participants that presented treatment emergent adverse events (TEAE) during the study overall, TEAEs related to study drug and severe TEAEs.
Outcome measures
| Measure |
RHB-105
n=228 Participants
RHB-105 (Rifabutin 150 mg, Amoxicillin 3000 mg, Omeprazole 120 mg)
|
Active Comparator
n=227 Participants
Active comparator (Amoxicillin 3000 mg, Omeprazole 120 mg)
|
|---|---|---|
|
Number of Participants With Adverse Events That Are Related to Treatment
No. of subjects with any TEAE
|
83 Participants
|
72 Participants
|
|
Number of Participants With Adverse Events That Are Related to Treatment
No. of subjects with any study drug related TEAE
|
47 Participants
|
44 Participants
|
|
Number of Participants With Adverse Events That Are Related to Treatment
No. of subjects with any severe TEAE
|
4 Participants
|
4 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 43-71 days after initiation of treatmentPopulation: Pharmacokinetic Population (PKP)
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.
Outcome measures
| Measure |
RHB-105
n=207 Participants
RHB-105 (Rifabutin 150 mg, Amoxicillin 3000 mg, Omeprazole 120 mg)
|
Active Comparator
n=184 Participants
Active comparator (Amoxicillin 3000 mg, Omeprazole 120 mg)
|
|---|---|---|
|
Number of Participants With Eradication of H. Pylori in the Pharmacokinetic Population (PKP)
|
187 Participants
|
119 Participants
|
Adverse Events
RHB-105
Active Comparator
Serious adverse events
| Measure |
RHB-105
n=228 participants at risk
RHB-105 (Rifabutin 150 mg, Amoxicillin 3000 mg, Omeprazole 120 mg)
|
Active Comparator
n=227 participants at risk
Active comparator (Amoxicillin 3000 mg, Omeprazole 120 mg)
|
|---|---|---|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.44%
1/228 • Number of events 1 • Adverse Events and Serious Adverse Events reported from first study drug administration and until 28 days following the last dose of blinded study drug.
|
0.00%
0/227 • Adverse Events and Serious Adverse Events reported from first study drug administration and until 28 days following the last dose of blinded study drug.
|
|
Nervous system disorders
Acute Encephalopathy
|
0.00%
0/228 • Adverse Events and Serious Adverse Events reported from first study drug administration and until 28 days following the last dose of blinded study drug.
|
0.44%
1/227 • Number of events 1 • Adverse Events and Serious Adverse Events reported from first study drug administration and until 28 days following the last dose of blinded study drug.
|
Other adverse events
| Measure |
RHB-105
n=228 participants at risk
RHB-105 (Rifabutin 150 mg, Amoxicillin 3000 mg, Omeprazole 120 mg)
|
Active Comparator
n=227 participants at risk
Active comparator (Amoxicillin 3000 mg, Omeprazole 120 mg)
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
10.1%
23/228 • Number of events 23 • Adverse Events and Serious Adverse Events reported from first study drug administration and until 28 days following the last dose of blinded study drug.
|
7.9%
18/227 • Number of events 18 • Adverse Events and Serious Adverse Events reported from first study drug administration and until 28 days following the last dose of blinded study drug.
|
|
Gastrointestinal disorders
Nausea
|
4.8%
11/228 • Number of events 11 • Adverse Events and Serious Adverse Events reported from first study drug administration and until 28 days following the last dose of blinded study drug.
|
5.3%
12/227 • Number of events 12 • Adverse Events and Serious Adverse Events reported from first study drug administration and until 28 days following the last dose of blinded study drug.
|
|
Nervous system disorders
Headache
|
7.5%
17/228 • Number of events 17 • Adverse Events and Serious Adverse Events reported from first study drug administration and until 28 days following the last dose of blinded study drug.
|
7.0%
16/227 • Number of events 16 • Adverse Events and Serious Adverse Events reported from first study drug administration and until 28 days following the last dose of blinded study drug.
|
Additional Information
June Almenoff, Chief Scientific Officer
Redhill Biopharma Inc.
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60