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

NCT03198507 | Completed Phase 3 Results FDA Drug

• 1 other identifier: RHB-105-02
• Study Type: interventional
• Target: 455
• Locations: 1 country
• Sites: 55

Brief 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.

Conditions

Helicobacter Pylori Infection; Dyspepsia

Outcome Measures

Primary Outcomes (1)

• 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.

  43-71 days after initiation of treatment

Secondary Outcomes (2)

• Number of Participants With H. Pylori Cultures That Presented Antibiotic Resistance and Susceptibility

  43-71 days after initiation of treatment

• Number of Participants With Adverse Events That Are Related to Treatment

  After first dose of study drug until 28 days following last dose.

Other Outcomes (1)

• Number of Participants With Eradication of H. Pylori in the Pharmacokinetic Population (PKP)

  43-71 days after initiation of treatment

Study Arms (2)

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

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

Drug: Active Comparator

Interventions

RHB-105 DRUG

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.

Also known as: Amoxicillin, Omeprazole and Rifabutin

RHB-105

Active Comparator DRUG

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.

Also known as: Amoxicillin and Omeprazole

Active Comparator

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• RedHill Biopharma Limited: lead

Study Sites (55)

Research Site

Dothan, Alabama, 36305, United States

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Phoenix, Arizona, 85018, United States

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Tucson, Arizona, 85710, United States

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North Little Rock, Arkansas, 72117, United States

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Anaheim, California, 92801, United States

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Chula Vista, California, 91910, United States

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Lomita, California, 90717, United States

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San Carlos, California, 94070, United States

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Bristol, Connecticut, 06010, United States

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Aventura, Florida, 33180, United States

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Clearwater, Florida, 33765, United States

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Coral Springs, Florida, 33071, United States

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Homestead, Florida, 33030, United States

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Jacksonville, Florida, 28546, United States

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Lauderdale Lakes, Florida, 33319, United States

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Miami, Florida, 33144, United States

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Miami, Florida, 33165, United States

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Orange City, Florida, 32763, United States

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Palm Harbor, Florida, 34684, United States

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Athens, Georgia, 30607, United States

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Macon, Georgia, 31201, United States

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Marietta, Georgia, 30060, United States

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Elwood, Indiana, 46036, United States

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Metairie, Louisiana, 70006, United States

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Shreveport, Louisiana, 71105, United States

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Baltimore, Maryland, 21215, United States

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Chevy Chase, Maryland, 20815, United States

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Brockton, Massachusetts, 02302, United States

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Chesterfield, Missouri, 48047, United States

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Wyoming, Missouri, 49519, United States

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Las Vegas, Nevada, 89119, United States

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Las Vegas, Nevada, 89128, United States

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Great Neck, New York, 11023, United States

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Concord, North Carolina, 28025, United States

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Davidson, North Carolina, 28036, United States

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Fayetteville, North Carolina, 28304, United States

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Greenville, North Carolina, 27834, United States

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Tulsa, Oklahoma, 74135, United States

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Greenville, South Carolina, 29615, United States

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Sioux Falls, South Dakota, 57108, United States

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Hermitage, Tennessee, 37076, United States

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Nashville, Tennessee, 37203, United States

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Houston, Texas, 77043, United States

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Houston, Texas, 77079, United States

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Houston, Texas, 77084, United States

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Research Center

Houston, Texas, 77090, United States

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Houston, Texas, 77098, United States

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Longview, Texas, 75605, United States

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Richardson, Texas, 75082, United States

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San Antonio, Texas, 78229, United States

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Ogden, Utah, 84405, United States

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Charlottesville, Virginia, 22911, United States

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Christiansburg, Virginia, 24073, United States

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Lynchburg, Virginia, 24502, United States

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Milwaukee, Wisconsin, 53215, United States

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Related Publications (2)

• 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.

  PMID: 34862940 DERIVED

• Graham 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.

  PMID: 32365359 DERIVED

MeSH Terms

Conditions

Dyspepsia

Interventions

Amoxicillin; Omeprazole; Rifabutin

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Pyridines; Heterocyclic Compounds, 1-Ring; Benzimidazoles; Rifamycins; Heterocyclic Compounds, 4 or More Rings; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds

Results Point of Contact

• Title: June Almenoff, Chief Scientific Officer
• Organization: Redhill Biopharma Inc.

jalmenoff@redhillus.com

(984) 444 7010

Study Officials

• David Graham, MD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2017
• First Posted: June 26, 2017
• Study Start: June 18, 2017
• Primary Completion: October 24, 2018
• Study Completion: December 13, 2018
• Last Updated: March 16, 2020
• Results First Posted: March 16, 2020

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (55)