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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT03029091
Date of registration: 20/01/2017
Prospective Registration: Yes
Primary sponsor: Children's Hospital Medical Center, Cincinnati
Public title: An Open-Label Trial of Losartan Potassium in Participants With Eosinophilic Esophagitis (EoE)
Scientific title: A Preliminary Open-Label Trial of Losartan Potassium in Participants With Eosinophilic Esophagitis (EoE) With or Without a Connective Tissue Disorder
Date of first enrolment: May 23, 2017
Target sample size: 15
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT03029091
Study type:  Interventional
Study design:  Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).  
Phase:  Phase 2
Countries of recruitment
United States
Contacts
Name:     Marc E Rothenberg, MD, PhD
Address: 
Telephone:
Email:
Affiliation:  Children's Hospital Medical Center, Cincinnati
Key inclusion & exclusion 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, swallowed steroid and PPI therapies 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 (e.g., liver failure, history of liver
transplantation or persistent liver transaminase elevation).

- 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-immunoglobulin (Ig)E 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 a, 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)



Age minimum: 5 Years
Age maximum: 25 Years
Gender: All
Health Condition(s) or Problem(s) studied
Eosinophilic Esophagitis
Intervention(s)
Drug: Losartan Potassium
Primary Outcome(s)
Change From Baseline in Peak Eosinophil Count [Time Frame: Baseline, 16 weeks]
Number of Serious and Grade 3 or Higher Adverse Events [Time Frame: 20 weeks after the start of treatment (16 weeks treatment and 4 weeks follow-up)]
Secondary Outcome(s)
Change From Baseline in PedsQL EoE [Time Frame: Baseline, 16 weeks]
Change From Baseline in PEESS V2.0 [Time Frame: Baseline,16 weeks]
Change From Baseline in Total Endoscopic Reference Score [Time Frame: Baseline, 16 weeks]
Change From Baseline in Total Histology Scoring System [Time Frame: Baseline, 16 weeks]
Percent of Participants in Complete and Partial Histologic Remission at 16 Weeks [Time Frame: 16 weeks]
Secondary ID(s)
2015-9021
U54AI117804
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
National Center for Advancing Translational Science (NCATS)
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Office of Rare Diseases (ORD)
Ethics review
Results
Results available: Yes
Date Posted: 10/08/2020
Date Completed:
URL: https://clinicaltrials.gov/ct2/show/results/NCT03029091
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