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Status:

COMPLETED

Antibody Treatment for Advanced Celiac Disease

Lead Sponsor:

National Cancer Institute (NCI)

Collaborating Sponsors:

Mayo Clinic

Conditions:

Celiac Disease

Celiac Sprue

Eligibility:

All Genders

18-100 years

Phase:

PHASE1

Brief Summary

Background: \- Celiac disease is a condition where the immune system attacks the cells of the small intestine. The intestine becomes inflamed and cannot digest food properly. The disease most often c...

Detailed Description

Background: * Celiac disease is a complex inflammatory disorder with an autoimmune component characterized by a dramatic expansion of intraepithelial cytotoxic T lymphocytes that usually regress on a...

Eligibility Criteria

Inclusion

  • INCLUSION CRITERIA
  • 1.1.1 Patients must be greater than or equal to 18-years-old.
  • 1.1.2 All patients must have a pathologically confirmed diagnosis of refractory celiac disease(RCD) defined by internationally accepted criteria of persistent and recurrent symptoms(diarrhea, weight loss, and abdominal pain) associated with intestinal damage, characterized by partial to total villous atrophy with intraepithelial lymphocytes defined by \> 25 intraepithelial lymphocytes per 100 epithelial cells.
  • 1.1.3 Persistence of the above signs and symptoms despite strict adherence to a gluten-free diet for 6-12 months
  • 1.1.4 Patients are to have had circulating antibodies to transglutaminase-1 or similar celiac specific serology
  • 1.1.5 Patients must have a life expectancy of \> 3 months
  • 1.1.6 Patients must have a creatinine of less than 2.0 mg/dL or if the patient has an elevated creatinine measured creatinine clearance (Ccr) must be \> 60 mL/min/1.73m(2)
  • 1.1.7 Patients must have a serum alkaline phosphatase, ALT (SGPT) and AST (SGOT) less than 3x the upper limits of normal (ULN)
  • 1.1.8 Patients must have a total bilirubin of less than 2.5 x ULN
  • 1.1.9 Women of childbearing potential must have a negative beta HCG pregnancy test at initial screening and within 3 days prior to registration
  • 1.1.10 Patients receiving a stable dose (\> 4 weeks) of corticosteroid therapy equal to 20 mg of prednisone per day or less are eligible
  • 1.1.11 Patients with a history of curatively treated basal cell carcinoma or intraepithelial neoplasia of the uterine surface will be allowed on the study
  • 1.1.12 Patients must be able to understand and sign an informed consent
  • EXCLUSION CRITERIA
  • 1.2.1 Patients enrolled in another therapeutic study
  • 1.2.2 Patients with a history of venous thrombosis
  • 1.2.3 Patients with antibodies to Hu-Mik-Beta-1
  • 1.2.4 A contraindication to monoclonal antibody therapy including adverse events related to prior monoclonal antibody therapy. Patients who have received prior antibody therapy will have permanent medical records reviewed by the study investigator.
  • 1.2.5 Any uncontrolled or chronic bacterial, mycobacterial or other viral (e.g., herpes virus), fungal, parasitic or protozoal infection
  • 1.2.6 History of malignancy (active or within the previous 5 years)
  • 1.2.7 Patients with HIV infection (antibody positive) with positive confirmatory molecular tests
  • 1.2.8 Patients who have chronic hepatitis B or chronic hepatitis C
  • 1.2.9 Pregnant or breastfeeding women. Women who not using an acceptable method of contraception. Acceptability of various methods of contraception will be determined by the investigator. Postmenopausal or surgically sterile women who have documentation of postmenopausal status or surgical sterility availability prior to enrollment.
  • 1.2.10 Patients with significant co-morbidities including uncontrolled hypertension (diastolic B/P \> 115 mm/Hg), unstable angina, congestive heart failure (\> N.Y.H.A. Class II), poorly controlled diabetes, severe chronic pulmonary disease, coronary angioplasty or myocardial infarction within the last 6 months or uncontrolled atrial or ventricular cardiac arrhythmias.
  • 1.2.11 Abnormal screening/baseline tests exceeding the limits outlined below:
  • Total white blood cell count (WBC) \<300/mm(3)
  • Platelet count \<85,000/mm(3)
  • INR greater than or equal to 1.5
  • Serum creatinine level \> 1.5 mg/dL
  • Serum alanine transaminase, aspartate transaminase or creatinine kinase \> 2 x the upper limits of normal
  • 1.2.12 Patients with a history of a psychiatric disorder that may interfere with the understanding and compliance with this protocol, and the required follow-up
  • 1.2.13 Exclusion at the discretion of the PI or delegate if participation in the study is deemed too risky (e.g., clinically significant pleural or pericardial effusion or ascites)
  • 1.2.14 Inability to give informed consent
  • 1.2.15 History of diverticulitis

Exclusion

    Key Trial Info

    Start Date :

    June 12 2013

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    December 20 2019

    Estimated Enrollment :

    5 Patients enrolled

    Trial Details

    Trial ID

    NCT01893775

    Start Date

    June 12 2013

    End Date

    December 20 2019

    Last Update

    January 18 2020

    Active Locations (1)

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    Page 1 of 1 (1 locations)

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    Mayo Clinic, Rochester

    Rochester, Minnesota, United States, 55905