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An Open-Label Trial of Losartan Potassium in Participants With Eosinophilic Esophagitis (EoE)

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ClinicalTrials.gov Identifier: NCT03029091
Recruitment Status : Recruiting
First Posted : January 24, 2017
Last Update Posted : September 21, 2018
Sponsor:
Collaborators:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institute of Allergy and Infectious Diseases (NIAID)
Office of Rare Diseases (ORD)
National Center for Advancing Translational Science (NCATS)
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati

Brief Summary:
The purpose of this study is to test the safety and effectiveness of Losartan potassium in subjects with Eosinophilic Esophagitis (EoE), both those with a connective tissue disorder (CTD) and those without a CTD.

Condition or disease Intervention/treatment Phase
Eosinophilic Esophagitis Drug: Losartan Potassium Phase 2

Detailed Description:

The purpose of this research study is to test the safety of Losartan potassium to see what effects (good and bad) it has on participants and their Eosinophilic Esophagitis (EoE). If a subject has Connective Tissue Disease (CTD) the researchers want to see what effects (good or bad) Losartan has on EoE.

EoE is an inflammatory disease in the esophagus (the tube leading from the mouth to the stomach) that is typically triggered by exposure to certain things in food. Connective Tissue Disorders (CTDs) are disorders that affect the connective tissues in the body, such as fat, bone, and cartilage.

Eosinophils release a protein called TGF-beta. Losartan may decrease the amount of the protein and therefore help EoE and CTD.

Losartan is a drug that is approved by the United States Food and Drug Administration (FDA) for use in adults and children over 6 years of age who have high blood pressure. This medication has not been studied in people with EoE.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Single Group Assignment
Intervention Model Description: This study is an open-label study, which means that all participants receive the study medicine.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Preliminary Open-Label Trial of Losartan Potassium in Participants With Eosinophilic Esophagitis (EoE) With or Without a Connective Tissue Disorder
Actual Study Start Date : January 19, 2017
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : August 2019


Arm Intervention/treatment
Experimental: Losartan treatment
Treatment with Losartan potassium
Drug: Losartan Potassium
Participants will receive Losartan potassium for 4 months.
Other Name: Losartan




Primary Outcome Measures :
  1. Change in Peak Esophageal Eosinophil Count [ Time Frame: 4 months ]
    Change from baseline in peak esophageal eosinophil count at the end of treatment visit (or early withdrawal)


Secondary Outcome Measures :
  1. Change in TGF-beta levels [ Time Frame: 4 months ]
    Change from baseline in blood and esophageal TGF-beta levels at end of treatment (or early withdrawal)



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Ages Eligible for Study:   5 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Written informed consent/assent
  • confirmed, active EoE (at Screening or within 12 weeks prior to enrollment)
  • does or does not have diagnosis of a connective tissue disorder (CTD)
  • has been on a high dose of proton pump inhibitor (PPI) for at least 8 weeks prior to a diagnostic endoscopy of EoE without histologic resolution (i.e., ≥ 15 eosinophils/HPF).
  • maintain the same diet throughout the duration of the study
  • female participants must be either:

    1. of non-childbearing potential (pre-menarchal or surgically sterile with documentation). OR
    2. have a negative urine pregnancy test at screening and at each monthly study visit.

Exclusion Criteria:

  • Any past or planned cardiac surgery.
  • An aortic root Z-score ≥ 3.0 on a previous echocardiogram.
  • Intolerance to losartan
  • A mean blood pressure measurement (both systolic and diastolic) at screening that is below the 2nd percentile for his/her age
  • Renal dysfunction
  • Another disorder that causes esophageal eosinophilia (e.g., hypereosinophilic syndrome, Churg Strauss vasculitis, eosinophilic granuloma, or a parasitic infection).
  • A diagnosis of hepatic insufficiency.
  • A history of abnormal gastric or duodenal biopsy or documented gastrointestinal disorders (e.g., Celiac Disease, Crohn's disease or Helicobacter pylori infection), not including chronic gastritis, chronic duodenitis, mucosal eosinophilia or other eosinophilic gastrointestinal disorders (EGIDs).
  • Use of anti-IgE monoclonal antibody (mAb), anti-tumor necrosis factor [TNF] mAb, anti-IL-5 agents, or anti-IL-13 within 6 months prior to study entry
  • Use of methotrexate, cyclosporine, interferon α, or other systemic immunosuppressive or immunomodulating agents within 3 months prior to the screening visit.
  • A stricture during endoscopy procedure that prevents passage of the endoscope
  • Taking or is planning to take an angiotensin receptor blocker (ARB), angiotensin-converting enzyme inhibitor (ACEI), beta blocker (BB), or calcium-channel blocker therapy at the screening visit or at any time during the study or has been taking any of these medications for 3 months prior to the screening visit.
  • Taking or planning to take hydrochlorothiazide, digoxin, warfarin, cimetidine, phenobarbital, rifampin, or fluconazole.
  • taking or planning to take potassium supplements or salt substitutes containing potassium.
  • A female participant who is pregnant or nursing or, if of childbearing potential, is not using a medically accepted, effective method of birth control (e.g., condom, oral/injectable/subcutaneous contraceptive, intrauterine device, or sexual abstinence).
  • Participated/participating in any investigative drug or device study within 30 days prior to study entry.
  • Participated/participating in any investigative biologics study within 3 months prior to study entry.
  • Unable to be confirmed, active EoE (at Screening or within 12 weeks prior to enrollment)

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): NCT03029091


Contacts
Contact: Heidi Poppendeck, MPH 513-803-3078 heidi.poppendeck@cchmc.org
Contact: Heather Foote (513) 803-1155 Heather.Foote@cchmc.org

Locations
United States, California
University of California, San Diego Recruiting
La Jolla, California, United States, 92093
Contact: Lea Jacinto    858-246-2144    ljacinto@ucsd.edu   
Principal Investigator: Seema Aceves, M.D., PhD         
United States, Illinois
Northwestern University Recruiting
Chicago, Illinois, United States, 60208
Contact: Angelika Zalewski    312-695-4054    angelika.zalewski@northwestern.edu   
Principal Investigator: Ikuo Hirano, M.D.         
United States, Ohio
Cincinnati Children's Hospital Medical Center Recruiting
Cincinnati, Ohio, United States, 45229
Contact: Heather Foote    513-803-1155    Heather.Foote@cchmc.org   
Principal Investigator: J. Pablo Abonia, MD         
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institute of Allergy and Infectious Diseases (NIAID)
Office of Rare Diseases (ORD)
National Center for Advancing Translational Science (NCATS)
Investigators
Principal Investigator: Marc E Rothenberg, MD, PhD Children's Hospital Medical Center, Cincinnati

Additional Information:
Responsible Party: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT03029091     History of Changes
Other Study ID Numbers: 2015-9021
First Posted: January 24, 2017    Key Record Dates
Last Update Posted: September 21, 2018
Last Verified: September 2018
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:
Esophagitis
Eosinophilic Esophagitis
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Eosinophilia
Leukocyte Disorders
Hematologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Losartan
Anti-Arrhythmia Agents
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action