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Trial record 12 of 12 for:    RedHill Biopharma

ERADICATE Hp - Treating Helicobacter Pylori With RHB-105 (ERADICATE Hp)

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ClinicalTrials.gov Identifier: NCT01980095
Recruitment Status : Completed
First Posted : November 8, 2013
Results First Posted : January 10, 2017
Last Update Posted : September 24, 2019
Sponsor:
Information provided by (Responsible Party):
RedHill Biopharma Limited

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Conditions Dyspepsia
Helicobacter Pylori Infection
Interventions Drug: RHB-105
Drug: Placebo
Enrollment 119
Recruitment Details  
Pre-assignment Details  
Arm/Group Title RHB-105 Placebo
Hide Arm/Group Description

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

Capsules that look like the RHB-105 product but contain no active ingredient.
Period Title: Overall Study
Started 78 [1] 41 [1]
Treated 77 [2] 41
Completed 63 30
Not Completed 15 11
Reason Not Completed
Lost to Follow-up             6             7
Withdrawal by Subject             2             3
Poor compliance             5             0
Safety issue             0             1
Study drug discontinued             1             0
Randomized by mistake             1             0
[1]
Protocol planned for 90 patients, protocol amendment increase up to 120 patients.
[2]
Of 78 patients randomized, 1 patient erroneously randomized and not treated
Arm/Group Title RHB-105 Placebo Total
Hide Arm/Group Description

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.

Capsules that look like the RHB-105 product but contain no active ingredient. Total of all reporting groups
Overall Number of Baseline Participants 77 41 118
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 77 participants 41 participants 118 participants
46.2  (10.56) 45.8  (9.52) 46  (10.18)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 77 participants 41 participants 118 participants
Female
28
  36.4%
16
  39.0%
44
  37.3%
Male
49
  63.6%
25
  61.0%
74
  62.7%
1.Primary Outcome
Title The Occurrence of H. Pylori Eradication as Confirmed Via 13C UBT Testing
Hide Description 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.
Time Frame 28-56 days after completion of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title RHB-105 Placebo
Hide Arm/Group Description:

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

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.

Overall Number of Participants Analyzed 66 37
Measure Type: Count of Participants
Unit of Measure: Participants
H. pylori eradication success
59
  89.4%
1
   2.7%
H. pylori eradication failure
7
  10.6%
36
  97.3%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection RHB-105
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments [Not Specified]
Method One-sample Z-test, RHB-105 subjects only
Comments [Not Specified]
2.Other Pre-specified Outcome
Title H. Pylori Eradication
Hide Description The occurrence of H. pylori eradication in Placebo and Active Drug Eradication Failure Patients treated with Standard of Care (SOC) treatment
Time Frame 28-56 days after completion of SOC treatment
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo Subjects Active Drug Eradication Failure Subjects
Hide Arm/Group Description:
These patients failed h.pylori eradication on study drug (placebo) and were subsequently treated with standard of care therapy as per the investigator
These patients failed h.pylori eradication on study drug (active) and were subsequently treated with standard of care therapy as per the investigator.
Overall Number of Participants Analyzed 27 4
Measure Type: Count of Participants
Unit of Measure: Participants
H. pylori eradication success
17
  63.0%
2
  50.0%
H. pylori eradication failure
10
  37.0%
2
  50.0%
Time Frame 1 year and 10 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title RHB-105 Placebo
Hide Arm/Group Description 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. Identical capsules that look like the RHB-105 product but contain no active ingredient.
All-Cause Mortality
RHB-105 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
RHB-105 Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/77 (1.30%)      1/41 (2.44%)    
Blood and lymphatic system disorders     
Anemia of Grade 3  1/77 (1.30%)  1 0/41 (0.00%)  0
Skin and subcutaneous tissue disorders     
Perirectal Abscess  0/77 (0.00%)  0 1/41 (2.44%)  1
1
Term from vocabulary, MedDRA (16.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
RHB-105 Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   38/77 (49.35%)      17/41 (41.46%)    
Gastrointestinal disorders     
Diarrhoea  11/77 (14.29%)  14 4/41 (9.76%)  4
Abdominal tenderness  5/77 (6.49%)  5 3/41 (7.32%)  3
Flatulence  2/77 (2.60%)  2 3/41 (7.32%)  3
Nervous system disorders     
Headache  10/77 (12.99%)  13 4/41 (9.76%)  4
Dizziness  3/77 (3.90%)  4 3/41 (7.32%)  3
Renal and urinary disorders     
Chromaturia  10/77 (12.99%)  10 1/41 (2.44%)  1
1
Term from vocabulary, MedDRA (16.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Ira Kalfus
Organization: RedHill Biopharma
Phone: 1-917-817-7517
EMail: ira@redhillbio.com
Layout table for additonal information
Responsible Party: RedHill Biopharma Limited
ClinicalTrials.gov Identifier: NCT01980095     History of Changes
Other Study ID Numbers: RHB-105-01
First Submitted: November 4, 2013
First Posted: November 8, 2013
Results First Submitted: November 13, 2016
Results First Posted: January 10, 2017
Last Update Posted: September 24, 2019