Helicobacter Pylori InfectionPhase 3ERADICATE Hp2NCT03198507
ERADICATE Hp2 - Treating Helicobacter Pylori With RHB-105 Compared to Active Comparator
A Phase 3 study testing RHB-105 and Active Comparator in people with Helicobacter Pylori Infection and Dyspepsia, run by RedHill Biopharma Limited at 55 sites in United States.
Trial summary
The "test and treat" strategy for treating dyspeptic patients who are H. pylori positive is rapidly becoming the standard of care. This study will test the effectiveness of RHB-105, a new triple therapy to treat H. pylori infection in dyspeptic patients against an active comparator. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Helicobacter Pylori Infection, Dyspepsia
- What is being tested?
- RHB-105 and Active Comparator
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 455 participants
- Where
- 55 sitesUnited States
- Study dates
- 18 Jun 2017to 13 Dec 2018
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 East, Southeast Asia, or the Indian subcontinent, including, for example, Cambodia, China, India, Japan, Korea, Malaysia, Pakistan, the Philippine Islands, Thailand, and Vietnam should be considered Asian, and forr this study Asian is defined as having at least one Asian grandparent (Shektar et al, 2014, FDA Guidance for Industry 2016);
- Positive for H. pylori by 13C Urea Breath Test (UBT) and confirmed positive via gastric biopsy for campylobacter-like organism (CLO) Rapid Urease Test, or H. pylori culture or histology;
- Symptoms consistent with dyspepsia of at least two weeks duration (defined as recurrent pain or discomfort centered in the upper abdomen, often with a relation to meals);
- Females must not be pregnant or lactating and:
- at no risk of pregnancy for one of the following reasons: postmenopausal for at least one year from the date of informed consent, status post hysterectomy or tubal ligation, OR
- are prepared to and agree to use of an intrauterine device (IUD) or practice double method birth control (barrier plus spermicide) from screening through to 30 days post-end of-treatment (EOT); Acceptable double contraceptive methods include barrier (condoms or diaphragms) plus spermicide
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- Hormonal contraceptives (birth control pills and hormone implants) are not acceptable contraception methods under this protocol;
- Males must be surgically sterilized or are prepared to and agree to practice double method (barrier plus spermicide) birth control from screening through to 30 days post-EOT;
- Agree to refrain from consuming alcohol from 1 week prior to screening to Test of Cure/Visit 5;
- Agree to refrain from taking antacids from screening through day 15 and for at least 24 hours prior to Test of Cure/Visit 5 and if applicable at least 24 hours prior to Visit 8/Test of Cure;
- Agree to refrain from taking H2 blockers at least 24 hours prior to screening 13C UBT and at least 24 hours prior to Test of Cure/Visit 5 and if applicable at least 24 hours prior to Visit 8/Test of Cure;
- Agree to refrain from taking sucralfate from one week prior to screening through Test of Cure/Visit5;
- Agree to refrain from taking bismuth containing medications such as Pepto-BismolTM or other proton pump inhibitors (PPIs) from two weeks prior to screening through Test of Cure/Visit 5;
- Agrees to refrain from consuming grapefruit, or any other food or supplement known to significantly affect CYP3A4 or CYP2C19 activity from screening to day 15;
- Provide written informed consent to participate as shown by a signature of subject on the consent form.
Who cannot join
- Have alarm symptoms/signs (including unexplained anemia [iron deficiency], melena / hematemesis, anorexia, dysphagia, jaundice, weight loss);
- Have received prior H. pylori eradication therapy;
- Use of antibiotics in the 4 weeks immediately prior to screening 13C UBT;
- Use of any proton pump inhibitors (PPIs) or bismuth-containing medications (such as Pepto-BismolTM) within the 2 weeks immediately prior to screening 13C UBT;
- Use of any of the following medications within seven days prior screening: alfentanil, allopurinol, amlodipine, anti-herpes agents, anti-retroviral agents, apixaban, aprepitant, aripiprazole, astemizole, atorvastatin, boceprevir, buspirone, carbamazepine, cisapride, citalopram dosed greater than 20 mg /d, clomipramine, clopidogrel and other oral anticoagulants, colchicine, dapsone, dihydroergotamine, digoxin, diltiazem, ergotamine, felodipine, fluconazole, gleevec, hormonal contraceptives that are not exclusively norethindrone or norgestrel, imipramine, itraconazole, ketoconazole, latuda, lovastatin, mycophenolate mofetil, nifedipine, nisoldipine, nitrendipine, phenytoin, pimozide, probenecid, proguanil, quinine, roflumilast, terfenadine and voriconazole;
- Use of amiodarone;
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- Presence of more than two active gastric and/or duodenal ulcers;
- History of gastric outlet obstruction; or hypersecretory state (e.g., Zollinger Ellison Syndrome);
- History of esophageal or gastric surgery, except for simple closure of perforated ulcer;
- History of gastric cancer;
- History of malignancy within the past five years except for basal cell carcinoma of the skin or carcinoma in situ of the cervix that has been treated with no evidence of recurrence;
- Positive screening laboratory results for human immunodeficiency virus (HIV) antibody (HIV1 or HIV2), or hepatitis B surface antigen (HBs Ag), or hepatitis C antibody (HCV Ab), unless patient has documented sustained viral response evidenced by prior and/or current absence of viral RNA at least 24 weeks after completing antiviral therapy;
- Current drug or alcohol abuse or history of drug or alcohol abuse in the past 5 years from screening;
- Known hypersensitivity or suspected history of hypersensitivity reactions to any of the study drugs or related drugs, including cephalosporins and penicillin;
- Clinical evidence of any disease that in the opinion of the investigator might interfere with the subject's ability to participate in the trial;
- History of QT prolongation (QTc greater than 450ms in males and 460ms in females), or ventricular arrhythmia, including torsades de pointes;
- Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT) >3x Upper Limit of Normal (ULN), or Alkaline Phosphatase (APO4) >2x ULN, or Total Bilirubin >2x ULN. Subjects with confirmed diagnosis of Gilbert's Syndrome are excluded if Total Bilirubin > 2.5x ULN;
- Unable to communicate well with the Investigators and to comply with the study requirements;
- Involved in any other experimental drug or device protocol (outside of this RHB-105-02 study) within the 4 weeks immediately prior to screening visit through end of study;
- Subjects with creatinine clearance less than 30 ml/min at screening via estimated Cockcroft-Gault (eCGF) formula: eCGF or estimated creatinine clearance = [140 - age in years] * weight (kg) / 72 * Serum Creatinine (mg/dl) [multiply estimated rate by 0.85 for women], using actual body weight at screening.
Trial locations and contacts
55 sites in 1 country.
55 sites in 1 country
United States55 sites
Research Site
Anaheim, California, 92801
Research Site
Athens, Georgia, 30607
Research Site
Aventura, Florida, 33180
Research Site
Baltimore, Maryland, 21215
Research Site
Bristol, Connecticut, 06010
Research Site
Brockton, Massachusetts, 02302
Research Site
Charlottesville, Virginia, 22911
Research Site
Chesterfield, Missouri, 48047
Research Site
Chevy Chase, Maryland, 20815
Research Site
Christiansburg, Virginia, 24073
Research Site
Chula Vista, California, 91910
Research Site
Clearwater, Florida, 33765
Research Site
Concord, North Carolina, 28025
Research Site
Coral Springs, Florida, 33071
Research Site
Davidson, North Carolina, 28036
Research Site
Dothan, Alabama, 36305
Research Site
Elwood, Indiana, 46036
Research Site
Fayetteville, North Carolina, 28304
Research Site
Great Neck, New York, 11023
Research Site
Greenville, North Carolina, 27834
Research Site
Greenville, South Carolina, 29615
Research site
Hermitage, Tennessee, 37076
Research Site
Homestead, Florida, 33030
Research site
Houston, Texas, 77043
Research Site
Houston, Texas, 77079
Research Site
Houston, Texas, 77084
Research Center
Houston, Texas, 77090
Research site
Houston, Texas, 77098
Research Site
Jacksonville, Florida, 28546
Research Site
Las Vegas, Nevada, 89119
Research Site
Las Vegas, Nevada, 89128
Research Site
Lauderdale Lakes, Florida, 33319
Research Site
Lomita, California, 90717
Research Site
Longview, Texas, 75605
Research Site
Lynchburg, Virginia, 24502
Research Site
Macon, Georgia, 31201
Research Site
Marietta, Georgia, 30060
Research Site
Metairie, Louisiana, 70006
Research Site
Miami, Florida, 33144
Research Site
Miami, Florida, 33165
Research site
Milwaukee, Wisconsin, 53215
Research Site
Nashville, Tennessee, 37203
Research Site
North Little Rock, Arkansas, 72117
Research Site
Ogden, Utah, 84405
Research Site
Orange City, Florida, 32763
Research Site
Palm Harbor, Florida, 34684
Research Site
Phoenix, Arizona, 85018
Research Site
Richardson, Texas, 75082
Research Site
San Antonio, Texas, 78229
Research site
San Carlos, California, 94070
Research Site
Shreveport, Louisiana, 71105
Research Site
Sioux Falls, South Dakota, 57108
Research Site
Tucson, Arizona, 85710
Research Site
Tulsa, Oklahoma, 74135
Research Site
Wyoming, Missouri, 49519
About this study
Official title: A Randomized Double Blind Active Comparator Controlled Phase III Study to Assess the Safety and Efficacy of RHB-105 in the Treatment of Confirmed Helicobacter Pylori (H. Pylori) Infection
The "test and treat" strategy for treating dyspeptic patients who are H. pylori positive is rapidly becoming the standard of care. This study will test the effectiveness of RHB-105, a new triple therapy to treat H. pylori infection in dyspeptic patients against an active comparator.
Read the detailed description
This is a, randomized, double blind, active comparator-controlled study of RHB-105 in adult subjects complaining of epigastric discomfort that have been screened and found to be positive for H. pylori infection via 13C UBT and gastric biopsy.
The biopsy samples will also be used to conduct H. pylori antibiotic susceptibility/resistance assessment.
The study will be conducted at up to 65 sites in the USA. Eligible subjects will be randomized in a ratio of 1:1 between the RHB-105 arm (n=222) and the active comparator arm (n=222). Subjects will receive RHB-105 or active comparator for 14 consecutive days. Eradication of H. pylori infection will be determined at Visit 5 based on 13C UBT testing conducted between 43 and 71 days after initiation of study drug therapy.
All subjects who meet inclusion and exclusion criteria and have positive13C UBT will undergo upper endoscopy with sampling for culture and sensitivity testing (to rifabutin, amoxicillin, clarithromycin, and metronidazole) prior to randomization. After test of cure at Visit 5, all H. pylori eradication failures will receive susceptibility directed Standard of Care therapy based on initial culture results for subjects, and undergo repeat upper endoscopy for post treatment antibiotic susceptibility/resistance assessment.
- Conditions
- Helicobacter Pylori Infection, Dyspepsia
- Being tested
- RHB-105, Active Comparator
- Medical subject headings
- Dyspepsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RHB-105Drug
Also called Amoxicillin, Omeprazole and Rifabutin
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 ComparatorDrug
Also called Amoxicillin and Omeprazole
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: RHB-105 |
| 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 Receives: Drug: Active Comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Eradication of H. Pylori
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.
Measured: 43-71 days after initiation of treatment
Secondary outcomes (2)
Number of Participants With H. Pylori Cultures That Presented Antibiotic Resistance and Susceptibility
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.
Measured: 43-71 days after initiation of treatment
Number of Participants With Adverse Events That Are Related to Treatment
The number of participants that presented treatment emergent adverse events (TEAE) during the study overall, TEAEs related to study drug and severe TEAEs.
Measured: After first dose of study drug until 28 days following last dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2017
- Study start18 Jun 2017
- Primary completion24 Oct 2018
- Study completion13 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Helicobacter Pylori InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 455 participants (actual)
Sponsor and investigators
- Lead sponsor
- RedHill Biopharma Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Graham, MD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03198507
- Sponsor's protocol ID
- RHB-105-02
- Acronym
- ERADICATE Hp2
- Status last verified
- Aug 2018
- First submitted
- 7 Jun 2017
- Last updated
- 16 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Howden CW, Sheldon KL, Almenoff JS, Chey WD. Pitfalls of Physician-Directed Treatment of Helicobacter pylori: Results from Two Phase 3 Clinical Trials and Real-World Prescribing Data. Dig Dis Sci. 2022 Sep;67(9):4382-4386. doi: 10.1007/s10620-021-07323-5. Epub 2021 Dec 4.
PubMed 34862940Graham DY, Canaan Y, Maher J, Wiener G, Hulten KG, Kalfus IN. Rifabutin-Based Triple Therapy (RHB-105) for Helicobacter pylori Eradication: A Double-Blind, Randomized, Controlled Trial. Ann Intern Med. 2020 Jun 16;172(12):795-802. doi: 10.7326/M19-3734. Epub 2020 May 5.
PubMed 32365359
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Double Blind Active Comparator Controlled Phase III Study to Assess the Safety and Efficacy of RHB-105 in the Treatment of Confirmed Helicobacter Pylori (H. Pylori) Infection
- ClinicalTrials.gov ID
- NCT03198507
- Acronym / sponsor ID
- ERADICATE Hp2 / RHB-105-02
- Conditions
- Helicobacter Pylori Infection, Dyspepsia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 455 participants (actual)
- Lead sponsor
- RedHill Biopharma LimitedIndustry (pharma, biotech, devices)
- Study start
- 18 Jun 2017 (actual)
- Primary completion
- 24 Oct 2018 (actual)
- Study completion
- 13 Dec 2018 (actual)
- First posted
- 26 Jun 2017 (actual)
- Results
- Posted 16 Mar 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The "test and treat" strategy for treating dyspeptic patients who are H. pylori positive is rapidly becoming the standard of care. This study will test the effectiveness of RHB-105, a new triple therapy to treat H. pylori infection in dyspeptic patients against an active comparator.
Detailed description
This is a, randomized, double blind, active comparator-controlled study of RHB-105 in adult subjects complaining of epigastric discomfort that have been screened and found to be positive for H. pylori infection via 13C UBT and gastric biopsy.
The biopsy samples will also be used to conduct H. pylori antibiotic susceptibility/resistance assessment.
The study will be conducted at up to 65 sites in the USA. Eligible subjects will be randomized in a ratio of 1:1 between the RHB-105 arm (n=222) and the active comparator arm (n=222). Subjects will receive RHB-105 or active comparator for 14 consecutive days. Eradication of H. pylori infection will be determined at Visit 5 based on 13C UBT testing conducted between 43 and 71 days after initiation of study drug therapy.
All subjects who meet inclusion and exclusion criteria and have positive13C UBT will undergo upper endoscopy with sampling for culture and sensitivity testing (to rifabutin, amoxicillin, clarithromycin, and metronidazole) prior to randomization. After test of cure at Visit 5, all H. pylori eradication failures will receive susceptibility directed Standard of Care therapy based on initial culture results for subjects, and undergo repeat upper endoscopy for post treatment antibiotic susceptibility/resistance assessment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RHB-105 | Experimental | Drug: RHB-105RHB-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 | Drug: Active ComparatorActive comparator is an 'all-in-one' combination oral capsule consisting of combination therapy of Amoxicillin and Omeprazole; as well as separate Riboflavin |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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 East, Southeast Asia, or the Indian subcontinent, including, for example, Cambodia, China, India, Japan, Korea, Malaysia, Pakistan, the Philippine Islands, Thailand, and Vietnam should be considered Asian, and forr this study Asian is defined as having at least one Asian grandparent (Shektar et al, 2014, FDA Guidance for Industry 2016);
- Positive for H. pylori by 13C Urea Breath Test (UBT) and confirmed positive via gastric biopsy for campylobacter-like organism (CLO) Rapid Urease Test, or H. pylori culture or histology;
- Symptoms consistent with dyspepsia of at least two weeks duration (defined as recurrent pain or discomfort centered in the upper abdomen, often with a relation to meals);
- Females must not be pregnant or lactating and:
- Males must be surgically sterilized or are prepared to and agree to practice double method (barrier plus spermicide) birth control from screening through to 30 days post-EOT;
Key exclusion criteria (20 listed)
- Have alarm symptoms/signs (including unexplained anemia [iron deficiency], melena / hematemesis, anorexia, dysphagia, jaundice, weight loss);
- Have received prior H. pylori eradication therapy;
- Use of antibiotics in the 4 weeks immediately prior to screening 13C UBT;
- Use of any proton pump inhibitors (PPIs) or bismuth-containing medications (such as Pepto-BismolTM) within the 2 weeks immediately prior to screening 13C UBT;
- Use of any of the following medications within seven days prior screening: alfentanil, allopurinol, amlodipine, anti-herpes agents, anti-retroviral agents, apixaban, aprepitant, aripiprazole, astemizole, atorvastatin, boceprevir, buspirone, carbamazepine, cisapride, citalopram dosed greater than 20 mg /d, clomipramine, clopidogrel and other oral anticoagulants, colchicine, dapsone, dihydroergotamine, digoxin, diltiazem, ergotamine, felodipine, fluconazole, gleevec, hormonal contraceptives that are not exclusively norethindrone or norgestrel, imipramine, itraconazole, ketoconazole, latuda, lovastatin, mycophenolate mofetil, nifedipine, nisoldipine, nitrendipine, phenytoin, pimozide, probenecid, proguanil, quinine, roflumilast, terfenadine and voriconazole;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RHB-105Also: Amoxicillin, Omeprazole and RifabutinThe 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. | Drug | RHB-105 |
| Active ComparatorAlso: Amoxicillin and OmeprazoleThe 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. | Drug | Active Comparator |
Primary outcome
Number of Participants With Eradication of H. Pylori
Time frame: 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.
2 secondary outcomes
Number of Participants With H. Pylori Cultures That Presented Antibiotic Resistance and Susceptibility
Time frame: 43-71 days after initiation of treatment
Number of Participants With Adverse Events That Are Related to Treatment
Time frame: After first dose of study drug until 28 days following last dose.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34862940Howden CW, Sheldon KL, Almenoff JS, Chey WD. Pitfalls of Physician-Directed Treatment of Helicobacter pylori: Results from Two Phase 3 Clinical Trials and Real-World Prescribing Data. Dig Dis Sci. 2022 Sep;67(9):4382-4386. doi: 10.1007/s10620-021-07323-5. Epub 2021 Dec 4.
- Derived from this study: PubMed 32365359Graham DY, Canaan Y, Maher J, Wiener G, Hulten KG, Kalfus IN. Rifabutin-Based Triple Therapy (RHB-105) for Helicobacter pylori Eradication: A Double-Blind, Randomized, Controlled Trial. Ann Intern Med. 2020 Jun 16;172(12):795-802. doi: 10.7326/M19-3734. Epub 2020 May 5.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Graham, MD principal investigator
Baylor College of Medicine
55 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing RHB-105 and Active Comparator in people with Helicobacter Pylori Infection and Dyspepsia, run by RedHill Biopharma Limited at 55 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 55 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Eradication of H. Pylori (time frame: 43-71 days after initiation of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03198507, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2020.