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

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ClinicalTrials.gov Identifier: NCT03198507
Recruitment Status : Recruiting
First Posted : June 26, 2017
Last Update Posted : June 28, 2017
Sponsor:
Information provided by (Responsible Party):
RedHill Biopharma Limited

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.

Condition or disease Intervention/treatment Phase
Helicobacter Pylori Infection Dyspepsia Drug: RHB-105 Drug: Active Comparator Phase 3

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 444 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : June 18, 2017
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: RHB-105
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

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.

Other Name: Amoxicillin, Omeprazole and Rifabutin
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

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.

Other Name: Amoxicillin and Omeprazole



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. H. pylori culture antibiotic resistance and susceptibility of H. pylori in culture. [ Time Frame: 42-70 days after initiation of treatment ]
    Eradication of H. pylori will be summarized within subgroups formed by the presence of H. pylori susceptibility and resistance to amoxicillin, clarithromycin, metronidazole and rifabutin determined based upon samples obtained prior to initiating study treatment.

  2. The plasma concentrations of amoxicillin, omeprazole, rifabutin, and the rifabutin metabolite 25-O-desacetyl-rifabutin. [ Time Frame: Day 13 after initiation of treatment ]
    The plasma concentrations of amoxicillin, omeprazole, rifabutin, and the rifabutin metabolite 25-O-desacetyl-rifabutin on Day 13 following the most recent dose.

  3. Number of participants with abnormal laboratory values and/or adverse events that are related to treatment [ Time Frame: Up to 71 days after initiation of treatment ]
    A summary of the occurrence and severity of treatment emergent adverse events during the study and changes from baseline in hematology and chemistry laboratory values.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Be ages 18 - 70, inclusive; males and females;
  2. 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;
  3. 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);
  4. Females must not be pregnant or lactating and:

    1. 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
    2. are prepared to and agree to practice double method birth control (barrier plus spermicide) from screening through to 30 days post-end of-treatment (EOT);
  5. 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;
  6. Agrees to refrain from consuming alcohol from 2 days prior to screening to day 15;
  7. Agrees to refrain from taking antacids or H2 blockers from screening through day 15;
  8. Agrees to refrain from taking bismuth containing medications such as Pepto-BismolTM or other proton pump inhibitors (PPIs) from screening through Test of Cure/Visit 5;
  9. 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;
  10. Provide written informed consent to participate as shown by a signature of subject on the consent form

Exclusion Criteria:

  1. Have alarm symptoms/signs (including unexplained anemia [iron deficiency], melena / hematemesis, anorexia, dysphagia, jaundice, weight loss);
  2. Have received prior H. pylori eradication therapy;
  3. Use of any bismuth-containing medications (such as Pepto-BismolTM) or antibiotics in the 4 weeks immediately prior to screening visit;
  4. Use of any proton pump inhibitors (PPIs) within the 2 weeks immediately prior to screening;
  5. Use of H2 blocker the evening prior to 13C UBT collection;
  6. 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;
  7. Use of amiodarone;
  8. Presence of more than two active gastric and/or duodenal ulcers;
  9. History of gastric outlet obstruction; or hypersecretory state (e.g., Zollinger Ellison Syndrome);
  10. History of esophageal or gastric surgery, except for simple closure of perforated ulcer;
  11. History of gastric cancer;
  12. 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;
  13. Current drug or alcohol abuse or history of drug or alcohol abuse in the past 10 years;
  14. Known hypersensitivity or suspected history of hypersensitivity reactions to any of the study drugs or related drugs, including cephalosporins, macrolides and penicillin;
  15. Clinical evidence of any disease that in the opinion of the investigator might interfere with the subject's ability to participate in the trial;
  16. History of QT prolongation or ventricular arrhythmia, including torsades de pointes;
  17. AST or ALT >3x ULN (Upper Limit of Normal), or APO4 (Alkaline Phosphatase) >2x ULN, or Total Bilirubin >2x ULN. Subjects with confirmed diagnosis of Gilbert's Syndrome are excluded if Total Bilirubin > 2.5x ULN;
  18. Unable to communicate well with the Investigators and to comply with the study requirements;
  19. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03198507


Contacts
Contact: Ira N Kalfus, MD +972-3-541-3131 ira@redhillbio.com

Locations
United States, Florida
Research Site Recruiting
Homestead, Florida, United States, 33030
Research Site Not yet recruiting
Jacksonville, Florida, United States, 28546
United States, New York
Research Site Recruiting
Great Neck, New York, United States, 11023
United States, Virginia
Research Site Recruiting
Charlottesville, Virginia, United States, 22911
Sponsors and Collaborators
RedHill Biopharma Limited
Investigators
Principal Investigator: David Graham, MD Baylor College of Medicine

Responsible Party: RedHill Biopharma Limited
ClinicalTrials.gov Identifier: NCT03198507     History of Changes
Other Study ID Numbers: RHB-105-02
First Posted: June 26, 2017    Key Record Dates
Last Update Posted: June 28, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Infection
Helicobacter Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Dyspepsia
Signs and Symptoms, Digestive
Signs and Symptoms
Amoxicillin
Rifabutin
Omeprazole
Riboflavin
Anti-Bacterial Agents
Anti-Infective Agents
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Photosensitizing Agents
Dermatologic Agents
Antibiotics, Antitubercular
Antitubercular Agents