Summary

for people ages 5-25 (full criteria)
at La Jolla, California and other locations
study started
estimated completion:
Seema Aceves

Description

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.

Official Title

A Preliminary Open-Label Trial of Losartan Potassium in Participants With Eosinophilic Esophagitis (EoE) With or Without a Connective Tissue Disorder

Details

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.

Keywords

Eosinophilic Esophagitis Esophagitis Losartan Losartan Potassium

Eligibility

You can join if…

Open to people ages 5-25

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

You CAN'T join if...

  • 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)

Locations

  • University of California, San Diego accepting new patients
    La Jolla California 92093 United States
  • Northwestern University accepting new patients
    Chicago Illinois 60208 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Children's Hospital Medical Center, Cincinnati
Links
Study information on the Consortium for Eosinophilic Gastrointestinal Disorders (CEGIR) website
ID
NCT03029091
Phase
Phase 2
Lead Scientist
Seema Aceves
Study Type
Interventional
Last Updated